| Changes to trial information |
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Public title |
21/07/2020 |
edit |
Therapeutic effect of physical activitiy associated with melatonin or synbiotic consumption on biological, psycho-cognitive and physiological adaptations in multiple sclerosis patients |
Therapeutic effect of physical activity associated with melatonin or synbiotic consumption on biological, psycho-cognitive and physiological adaptations in multiple sclerosis patients |
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Trial description |
21/01/2023 |
a sentence has been added to clarify that we will evaluate the effect of training alone and melatonin alone in addition to the effect of their combination |
Multiple sclerosis (MS) is an inflammatory, neurodegenerative and demyelinating disease of the central nervous system (CNS). The practice of adapted physical activity is part of medical care of people with (MS) which makes it possible to alleviate most of the disorders associated with MS (psycho-cognitive and balance disorder, muscle strength deficit and aerobic capacity impairment).Moreover, intense physical exercise leads to inflammation, oxidative stress and muscle damage. Melatonin (MEL) plays a neuroprotective role in MS-related neurodegeneration due to its anti-apoptotic, anti-inflammatory and antioxidant properties, also due to its role in remyelination process. Furthermore, sleep disturbances observed in people suffering from (MS) are due to the decrease in nocturnal concentrations of This hormone which is known as the "sleep hormone". In an animal model, the combined therapy of melatonin and exercise was studied showing that this combination reduced the side effects of fatigue and exercise-induced deficiency in spinal cord rats. However, studies on humans with (MS) are rare or non-existent. In addition, it has been shown that the alteration of the intestinal microbiota is associated with the development of MS. In this sense, the benefits of probiotic ingestion on inflammation, lipid profil and the degree of neurological disability linked to MS, have been demonstrated. However, no study has linked the effects of probiotic supplementation associated with physical activity in people with MS. Therefore, objectives of this study would be to evaluate the impact of melatonin and/or synbiotic supplementation associated with combined training (endurance, strength) on neuroimaging, psycho-physiological, immune and biochemical adaptations and psycho-cognitive performances. Application to MS : Bring new therapeutic strategies aimed at promoting neuroprotection, reducing inflammation and improving immune, physical and psychophysiological capabilities in MS patient. |
Multiple sclerosis (MS) is an inflammatory, neurodegenerative and demyelinating disease of the central nervous system (CNS). The practice of adapted physical activity is part of medical care of people with (MS) which makes it possible to alleviate most of the disorders associated with MS (psycho-cognitive and balance disorder, muscle strength deficit and aerobic capacity impairment).Moreover, intense physical exercise leads to inflammation, oxidative stress and muscle damage. Melatonin (MEL) plays a neuroprotective role in MS-related neurodegeneration due to its anti-apoptotic, anti-inflammatory and antioxidant properties, also due to its role in remyelination process. Furthermore, sleep disturbances observed in people suffering from (MS) are due to the decrease in nocturnal concentrations of This hormone which is known as the "sleep hormone". In an animal model, the combined therapy of melatonin and exercise was studied showing that this combination reduced the side effects of fatigue and exercise-induced deficiency in spinal cord rats. However, studies on humans with (MS) are rare or non-existent. In addition, it has been shown that the alteration of the intestinal microbiota is associated with the development of MS. In this sense, the benefits of probiotic ingestion on inflammation, lipid profil and the degree of neurological disability linked to MS, have been demonstrated. However, no study has linked the effects of probiotic supplementation associated with physical activity in people with MS. Therefore, objectives of this study would be to evaluate the impact of melatonin and/or synbiotic supplementation associated with combined training (endurance, strength) on neuroimaging, psycho-physiological, immune and biochemical adaptations and psycho-cognitive performances. The effects of training alone and melatonin alone on the these parameters will be also investigated in this project. Application to MS : Bring new therapeutic strategies to attenuate MS disorders |
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Trial phase |
03/03/2023 |
The experimental protocol has been completed and the statistical analyzes as well as the interpretation of certain data have been carried out |
Not Applicable |
Phase-3 |
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Anticipated trial start date |
22/12/2020 |
Given the increased deterioration of the health situation due to the COVID-19 pandemic, the practical work of the project has been postponed until the beginning of 2022 in order to ensure the safety of our patients |
01 Jan 2021 |
01 Jan 2022 |
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Actual trial start date |
02/12/2024 |
The actual trial start date was added in response to the reviewer's request |
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03 Jan 2022 |
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Anticipated date of last follow up |
22/12/2020 |
Given the increased deterioration of the health situation due to the COVID-19 pandemic, the practical work of the project has been postponed until the beginning of 2022 in order to ensure the safety of our patients |
30 Jun 2021 |
30 Jun 2022 |
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Completion date |
02/12/2024 |
The completion date was added in response to the reviewer's request |
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30 Jun 2022 |
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Final no of participants |
03/03/2023 |
Now the final sample size is concluded since the experimental procedure has been completed. |
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49 |
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Recruitment status |
21/07/2020 |
sorry, I made a mistake |
Closed to recruitment,follow-up continuing |
Not yet recruiting |
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Recruitment status |
12/04/2022 |
Recruitment is now completed |
Not yet recruiting |
Completed |
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| Study Design |
Masking / blinding |
12/04/2022 |
Blinding is also used for care provider |
Outcome Assessors, Participants |
Outcome Assessors, Care giver/Provider, Participants |
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| Intervention |
Intervention List |
28/06/2023 |
Clarify and update the tests used for assessments |
Control Group, Evaluation without physical training, 3 milligram of placebo per night (Galpharma Laboratories, Sfax, Tunisia), 12 weeks, This group will not be subjected to any physical activity throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of placebo (3 mg per nigth) (made made from starch and cellulose by Galpharma Laboratories, Sfax, Tunisie). The protocol consisted on two Blood samples, two neuroimaging, two subjective psycho-cognitive evaluations and two physiological and physical evaluations, 48 hours, pre and post 12 weeks of placebo ingestion only. One evaluation of Aerobic capacity and respiratory volumes will be measured using an Incremental exercise test and spirometry, 48h pre intervention. The inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). The blood samples will be conducted 48 hours pre and post intervention. Approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning at the Laboratory of Biochemistry. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. All biochemical parameters will be measured using automated analyzers (Beckman CX 9; IMX (Abbott)). For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: Static and dynamic balance measurements will be performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. Isokinetic knee strength will be measured with a Cybex® Norm II Medimex. Psycho-cognitive assessment will be performed using questionnaires., 15, Placebo |
Control Group, Evaluation without physical training, 3 milligram of placebo per night (Galpharma Laboratories, Sfax, Tunisia), 12 weeks, This group will not be subjected to any physical activity throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of placebo (3 mg per nigth) (made made from starch and cellulose by Galpharma Laboratories, Sfax, Tunisie). The protocol consisted on evaluating aerobic capacity, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post 12 weeks of placebo ingestion only. The inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure)., 15, Placebo |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
28/06/2023 |
To adjust intervnetion |
Control Group, Evaluation without physical training, 3 milligram of placebo per night (Galpharma Laboratories, Sfax, Tunisia), 12 weeks, This group will not be subjected to any physical activity throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of placebo (3 mg per nigth) (made made from starch and cellulose by Galpharma Laboratories, Sfax, Tunisie). The protocol consisted on evaluating aerobic capacity, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post 12 weeks of placebo ingestion only. The inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure)., 15, Placebo |
Control Group, Evaluation without physical training, 3 milligram of placebo per night (Galpharma Laboratories, Sfax, Tunisia), 12 weeks, This group will not be subjected to any physical activity throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of placebo (3 mg/nigth) (starch and cellulose by Galpharma Laboratories, Sfax, Tunisie). The protocol consisted on evaluating aerobic capacity, respiratory function, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post 12 weeks of placebo ingestion only. Inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. Aerobic capacity and pulmonary function were assessed using incremental cardiopulmonary test and spirometryFor physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography. For physical evaluation: walking analysis (Bessou locometer), Isokinetic knee strength (Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure), 15, Placebo |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
28/06/2023 |
To clarify and update the intervention |
Experimental Group, Training and melatonin supplementation , daily supplementation: 3 miligrams of melatonin (MEL) per night (Jamieson Laboratories, Toronto, Canada)
physical activity: 3 sessions per week, 12 weeks, The protocol consisted on two Blood samples, two neuroimaging, two subjective psycho-cognitive evaluations and two physiological and physical evaluations, 48 hours, pre and post concurrent training (three sessions/ week) for 12 weeks associated with a daily melatonin supplementation (3 mg / day). To evaluate the 12 weeks intervention effects, assessments will bmade prior to the initiation of melatonin supplementation and at the end of training period. One evaluation of Aerobic capacity and respiratory volumes will be measured using an Incremental exercise test and spirometry, 48h pre intervention. The inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). The blood samples will be conducted 48 hours pre and post intervention. Approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning at the Laboratory of Biochemistry. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. Biochemical parameters will be measured using automated analyzers (Beckman CX 9; IMX (Abbott)). For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: Static and dynamic balance measurements will be performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. Isokinetic knee strength will be measured with a Cybex® Norm II Medimex. Psycho-cognitive assessment will be performed using questionnaires. Participants of this group were asked to consume (orally) 3 mg of melatonin from the jamieson brand, each night 30 minutes before sleeping and to return the next day to perform a combined session (endurance then strength exercises) for 12 weeks., 15, |
Experimental Group, Training and melatonin supplementation , daily supplementation: 3 miligrams of melatonin (MEL) per night (Jamieson Laboratories, Toronto, Canada)
physical activity: 3 sessions per week, 12 weeks, The protocol consisted on evaluating aerobic capacity, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/ week) for 12 weeks associated with a daily melatonin supplementation (3 mg / day). Participants of this group were asked to consume (orally) 3 mg of melatonin from the jamieson brand, each night 30 minutes before sleeping and to return the next day to perform a combined session (endurance then strength exercises) for 12 weeks. For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure). , 15, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
29/06/2023 |
To adjust intervention |
Experimental Group, Training and melatonin supplementation , daily supplementation: 3 miligrams of melatonin (MEL) per night (Jamieson Laboratories, Toronto, Canada)
physical activity: 3 sessions per week, 12 weeks, The protocol consisted on evaluating aerobic capacity, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/ week) for 12 weeks associated with a daily melatonin supplementation (3 mg / day). Participants of this group were asked to consume (orally) 3 mg of melatonin from the jamieson brand, each night 30 minutes before sleeping and to return the next day to perform a combined session (endurance then strength exercises) for 12 weeks. For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure). , 15, |
Experimental Group, Training and melatonin supplementation , daily supplementation: 3 miligrams of melatonin (MEL) per night (Jamieson Laboratories, Toronto, Canada)
physical activity: 3 sessions per week, 12 weeks, The protocol consisted on evaluating aerobic capacity, respiratory function, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/week) for 12 weeks associated with melatonin supplementation (3 mg/night). Participants had to consume (orally) 3 mg of melatonin from the jamieson brand, each night 30 minutes before sleep and to return the next day to perform a combined session (endurance then strength exercises) for 12 weeks. For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Aerobic capacity and pulmonary function were assessed using incremental cardiopulmonary test and spirometry. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure)., 15, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
28/06/2023 |
To clarify the intervention and the evaluated parameters |
Experimental Group, Training and synbiotic supplementation , Daily supplemntation: 60 billion per night (Jamieson Laboratories, Toronto, Canada)
physical activity: 3 sessions per week , 12 weeks, The protocol consisted on two Blood samples, two subjective psycho-cognitive evaluations and two physiological and physical evaluations, 48 hours, pre and post concurrent training (three sessions/ week) for twelve weeks associated with a synbiotic supplementation (3 mg / day) for this group. To evaluate the 12 weeks of intervention effects, assessments will be made prior to the initiation of daily synbiotic supplementation and at the end of the 6-week training period. One evaluation of Aerobic capacity and respiratory volumes will be measured using an Incremental exercise test and spirometry, 48h pre intervention. The blood samples will be conducted 48 hours pre and post intervention. Approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning at the Laboratory of Biochemistry. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. Biochemical parameters will be measured using automated analyzers (Beckman CX 9; IMX (Abbott)). For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: Static and dynamic balance measurements will be performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. Isokinetic knee strength will be measured with a Cybex® Norm II Medimex. Psycho-cognitive assessment will be performed using questionnaires. Participants of this group were asked to consume (orally) 60 billion of synbiotic the jamieson brand per night and to return the next day to perform a combined training session (endurance then strength exercises) for 12 weeks, 15, |
Experimental Group, Training and synbiotic supplementation , Daily supplemntation: 60 billion per night (Jamieson Laboratories, Toronto, Canada)
physical activity: 3 sessions per week , 12 weeks, The protocol consisted on evaluating aerobic capacity, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/ week) for twelve weeks associated with a synbiotic supplementation (3 mg / day). Participants of this group were asked to consume (orally) 60 billion of synbiotic from the jamieson brand per night and to return the next day to perform a combined training session (endurance then strength exercises) for 12 weeks. For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure)., 15, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
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| Intervention |
Intervention List |
29/06/2023 |
To adjust the intervention |
Experimental Group, Training and synbiotic supplementation , Daily supplemntation: 60 billion per night (Jamieson Laboratories, Toronto, Canada)
physical activity: 3 sessions per week , 12 weeks, The protocol consisted on evaluating aerobic capacity, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/ week) for twelve weeks associated with a synbiotic supplementation (3 mg / day). Participants of this group were asked to consume (orally) 60 billion of synbiotic from the jamieson brand per night and to return the next day to perform a combined training session (endurance then strength exercises) for 12 weeks. For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure)., 15, |
Experimental Group, Training and synbiotic supplementation , Daily supplemntation: 60 billion per night (Jamieson Laboratories, Toronto, Canada)
physical activity: 3 sessions per week , 12 weeks, The protocol consisted on evaluating aerobic capacity, respiratory function, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/ week) for twelve weeks associated with a synbiotic supplementation (3 mg / day). Participants of this group were asked to consume (orally) 60 billion of synbiotic from the jamieson brand per night and to return the next day to perform a combined training session (endurance then strength exercises) for 12 weeks. For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Aerobic capacity and pulmonary function were assessed using incremental cardiopulmonary test and spirometry. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure)., 15, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
28/06/2023 |
To clarify the intervention |
Experimental Group, Training and placebo supplemntation, daily supplemntation: 3 milligrams of placebo (Galpharma Laboratories, Sfax, Tunisie)
physical training: 3 sessions per week, 12 weeks, The protocol consisted on two Blood samples, two neuroimaging, two subjective psycho-cognitive evaluations and two physiological and physical evaluations, 48 hours, pre and post concurrent training (three sessions/ week) for 12 weeks associated with a placebo supplementation (3 mg / day) for this group. One evaluation of Aerobic capacity and respiratory volumes will be measured using an Incremental exercise test and spirometry, 48h pre intervention. The inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). The blood samples were conducted 48 hours pre and post intervention. Approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning at the Laboratory of Biochemistry. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. Biochemical parameters will be measured using automated analyzers (Beckman CX 9; IMX (Abbott)). For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: Static and dynamic balance measurements will be performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. Isokinetic knee strength will be measured with a Cybex® Norm II Medimex. Psycho-cognitive assessment will be performed using questionnaires. Participants of this group were asked to ingest 3 mg of placebo (made from starch and cellulose in the laboratory of the local faculty of pharmacy) and to return the next day to perform a combined training session (endurance then strength training) for 12 weeks. Before starting the protocol, participants were familiarized with training exercises during 1 week., 15, |
Experimental Group, Training and placebo supplemntation, daily supplemntation: 3 milligrams of placebo (Galpharma Laboratories, Sfax, Tunisie)
physical training: 3 sessions per week, 12 weeks, The protocol consisted on evaluating aerobic capacity, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/ week) for 12 weeks associated with a placebo supplementation (3 mg / day). Participants of this group were asked to ingest 3 mg of placebo (made from starch and cellulose in the laboratory of the local faculty of pharmacy) and to return the next day to perform a combined training session (endurance then strength training) for 12 weeks. Before starting the protocol, participants were familiarized with training exercises during 1 week (3 to 4 sessions of familiarization). For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue a, 15, |
|
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
28/06/2023 |
To clarify the intervention |
Experimental Group, Training and placebo supplemntation, daily supplemntation: 3 milligrams of placebo (Galpharma Laboratories, Sfax, Tunisie)
physical training: 3 sessions per week, 12 weeks, The protocol consisted on evaluating aerobic capacity, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/ week) for 12 weeks associated with a placebo supplementation (3 mg / day). Participants of this group were asked to ingest 3 mg of placebo (made from starch and cellulose in the laboratory of the local faculty of pharmacy) and to return the next day to perform a combined training session (endurance then strength training) for 12 weeks. Before starting the protocol, participants were familiarized with training exercises during 1 week (3 to 4 sessions of familiarization). For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue a, 15, |
Experimental Group, Training and placebo supplemntation, daily supplemntation: 3 milligrams of placebo (Galpharma Laboratories, Sfax, Tunisie)
physical training: 3 sessions per week, 12 weeks, The protocol consisted on evaluating aerobic capacity, pulmonary function, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post concurrent training (three sessions/week) for 12 weeks associated with a placebo supplementation (3 mg/day). Participants were asked to ingest 3 mg of placebo (made from starch and cellulose in the laboratory of the local faculty of pharmacy) and to return the next day to perform a combined training session. Familiarization was perfomed before training (3-4 sessions). For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aerobic capacity and pulmonary function were assesed using incremental cardiopulmonary test and spirometry, respectively. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure). , 15, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
21/01/2023 |
This group was added to clarify that we will evaluate also the effect of melatonin alone by comparing data of melatonin group versus those of placebo group |
|
Experimental Group, Melatonin group, 3 milligram of melatonin per night , 12 weeks, This group will not be subjected to any physical activity throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of melatonin (3 mg per nigth) (Jamieson laboratories, Canada). The protocol consisted on two Blood samples, two neuroimaging, two subjective psycho-cognitive evaluations and two physiological and physical evaluations, 48 hours, pre and post 12 weeks of placebo ingestion only. One evaluation of Aerobic capacity and respiratory volumes will be measured using an Incremental exercise test and spirometry, 48h pre intervention. The inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). The blood samples will be conducted 48 hours pre and post intervention. Approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning at the Laboratory of Biochemistry. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. All biochemical parameters will be measured using automated analyzers (Beckman CX 9; IMX (Abbott)). For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: Static and dynamic balance measurements will be performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. Isokinetic knee strength will be measured with a Cybex® Norm II Medimex. Psycho-cognitive assessment will be performed using questionnaires., 15, |
|
Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
|
| Intervention |
Intervention List |
28/06/2023 |
To adjust the intervention |
Experimental Group, Melatonin group, 3 milligram of melatonin per night , 12 weeks, This group will not be subjected to any physical activity throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of melatonin (3 mg per nigth) (Jamieson laboratories, Canada). The protocol consisted on two Blood samples, two neuroimaging, two subjective psycho-cognitive evaluations and two physiological and physical evaluations, 48 hours, pre and post 12 weeks of placebo ingestion only. One evaluation of Aerobic capacity and respiratory volumes will be measured using an Incremental exercise test and spirometry, 48h pre intervention. The inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). The blood samples will be conducted 48 hours pre and post intervention. Approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning at the Laboratory of Biochemistry. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. All biochemical parameters will be measured using automated analyzers (Beckman CX 9; IMX (Abbott)). For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: Static and dynamic balance measurements will be performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. Isokinetic knee strength will be measured with a Cybex® Norm II Medimex. Psycho-cognitive assessment will be performed using questionnaires., 15, |
Experimental Group, Melatonin group, 3 milligram of melatonin per night , 12 weeks, The protocol consisted on evaluating aerobic capacity, respiratory function, physiological and physical parameters, psycho-cognitive performance, sleep quality, quality of life and perceptual records (pain and fatigue), and conducting two Blood samples and two neuroimageries, 48 hours, pre and post 12 weeks of melatonin ingestion only (3mg/night, 30 minutes before sleep). For neuroimaging: the inflammatory Lesions of central nervous system will be evaluated via cerebral and medullar Magnetic resonance imaging (MRI). For biological parameters (vitamins, hormones, oxidative stress, muscle damage, routine biochemical parameters, inflammation, extraction of messenger RNA from blood mononuclear cells): approximately 10 ml of venous blood will be taken from the arteriovenous fistula after supine rest in the morning. Samples will be immediately centrifuged at 3000 rpm and 4°C for 10 min. Aerobic capacity and pulmonary function were assesed using incremental cardiopulmonary test and spirometry, respectively. For physiological evaluation: central and peripheral fatigue will be investigated using an Electromyography (EMG). For physical evaluation: walking analysis (using Bessou locometer), Isokinetic knee strength (using Cybex dynamometer), manual dexterity (using nine hole peg test), fall risk (using four square step test), Static and dynamic postural balance (force platform, in eyes open and eyes closed conditions) will be assessed. For subjective evaluation: sleep quality, Psycho-cognitive performance, quality of life, fatigue and pain perceptions will be evaluated using questionnaires and cognitive tests (TMT, MoCA; SDMT, BVMT, Rey–Osterrieth complex figure). , 15, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Outcome |
OutCome List |
28/06/2023 |
Clarify and detail the parameters assessed |
Primary Outcome, 1- Change in Psychological parameters will be measured using hospital anxiety depression scale (HADS) which contains 14 items, divided into 2 subscales of 7 items (Anxiety or HADS-A; Depression or HADS-D). 2- change in cognitive function will be assessed using Simple reaction time (TRS), reaction time of choice (TRC) and Montreal cognitive assessment (MOCA) which assesses different cognitive domains: attention and concentration, executive functions, memory, language, Visio-constructional skills, conceptual thinking, calculations and orientation, 3-change in Sexual Function will be evaluated by Questionnaire on Intimacy and Sexuality Related to Multiple Sclerosis (QMS 19).4- Change in fatigue will be assessed by Fatigue severity scale (FSS): contains 9 questions which the patient answers on a Likert type scale ranging from 1 to 7, The higher is the score, the more is the fatigue. 5- change in sleep quality will be evaluated using Sleep Diary, Spiegel Sleep Questionnaire: includes 6 questions, its total score varies between 0 and 30 and whose score less than 18 corresponds to sleep disorders and Actimetry. 6- Change in Quality of life will be evaluated by The Short Form Health Survey (SF12) which includes 12 items divided into 8 dimensions (physical activity, life and relationships with others, physical pain, perceived health, vitality, limitations due to mental state, limitations due to physical condition and mental health). 7- Change in Nociceptive pain will be investigated using analog visual scale (EVA), for change in Neuropathic pain we will use the DN4 questionnaire which contains 7 items for the interrogation of the patient and 3 items for clinical examination. 8-Change in muscular damage :Creatine phosphokinase (CPK),Transaminase aspartate aminotransferases (ASAT) and Alanine aminotransferase (ALAT) and Lactate dehydrogenase (LDH) will be measured using Kinetic method at 340 nm and Gamma-glutamyltranspeptidase (Gamma GT) using Colorimetric method at 405 nm.
, 48 hours before and after intervention |
Primary Outcome, 1- Change in Psychological parameters will be measured using hospital anxiety depression scale (HADS). 2- change in cognitive function will be assessed using Simple reaction time (TRS), Trail Making test (TMT), Brief visual memory test (BVMT), Symbol Digit Modalities Test (SDMT), Rey–Osterrieth complex figure and Montreal cognitive assessment (MOCA), 3-change in Sexual Function will be evaluated by Questionnaire on Intimacy and Sexuality Related to Multiple Sclerosis .4- Change in fatigue: Fatigue severity scale (FSS), 5- change in sleep quality: Sleep Diary, Spiegel Sleep Questionnaire and Actigraphy. 6- Change in Quality of life : The Multiple Sclerosis International Quality of Life questionnaire (MusiQoL). 7- Change in Nociceptive pain will be investigated using analog visual scale (EVA), for change in Neuropathic pain we will use the DN4 questionnaire which contains 7 items for the interrogation of the patient and 3 items for clinical examination. 8-Change in muscle damage :Creatine phosphokinase (CPK),Transaminase aspartate aminotransferases (ASAT) and Alanine aminotransferase (ALAT) and Lactate dehydrogenase (LDH) and Gamma-glutamyltranspeptidase (Gamma GT), 8-change in oxidative stress: Malondialdehyde (MDA), Advanced Oxidation Protein Products (AOPP), reduced glutathione (GSH), bilirubin, uric acid, carbonylated proteins, catalase, superoxyde dismutase (SOD) and glutathione reductase (GR), 48 hours before and after intervention |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Outcome |
OutCome List |
28/06/2023 |
To clarify the evaluated parameters |
Secondary Outcome, 1-Neuroimaging will be performed using Magnetic resonance imaging (MRI) of the brain and spinal cord. 2- Cardio-respiraotry cpacity will be measured during An incremental exercise test with using spirometry one time: pre intervention). 3-Physiological response: change in central and peripheral fatigue will be measured using electromyography (EMG), change in Cardiac variability, resting heart rate will be assessed using (Polar Team 2, Finland), systolic blood pressure and diastolic blood pressure using blood pressure monitor.4- Change in Physical parameters :The Isokinetic knee strength was measured with a Cybex® Norm II Medimex, Static and dynamic postural stability test will be performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform, 6 Minute Walk Test (6 MWT) will be performed with measuring heart rate (HR) and "Pulsed" oxygen saturation using Pulse oximeter - SpO2 saturometer. 5- Change in biochemical parameters :The complete blood count (CBC) with Phenotyping of sub-leukocyte populations (Monocytes, lymphocytes), change in neuronal growth : Brain derived neurotropic factor (BDNF), change in lipid profile (i.e. Total Cholesterol (TC), High-density lipoprotein (HDL), Lowdensity lipoprotein (LDL) and Triglycerides (TG)) will be measured enzymatically,metabolic change in lactate and glucose will be measured using Lactate oxidase / peroxidase colorimetric enzymatic method and glucose oxidase / peroxidase colorimetric enzymatic method respectively, Change in inflammation: Interleukin 6 (IL-6), Tumor necrosis factor (Tnfα), CRP will be measured with Latex particle immunoturbidimetric test. Change in hormones: Serum melatonin, Testosterone, Estrogen, Progesterone, Cortisol and Insulin concentrations were assessed by chemiluminescent micro-particle immunoassay (CMIA)., 48 hours before and after intervention |
Secondary Outcome, 1-Neuroimaging will be performed using Magnetic resonance imaging (MRI) of the brain and spinal cord. 2- Cardio-respiratory capacity using an incremental cardiopulmonary test, 3-pulmonary function: spirometry, -Physiological response: change in central and peripheral fatigue will be measured using electromyography (EMG), change in Cardiac variability, resting heart rate variability (Polar), systolic blood pressure and diastolic blood pressure using blood pressure monitor.4- Change in Physical parameters :Isokinetic knee strength was measured with an isokinetic dynamometer (Cybex), fall risk: the four square step test, walking analysis using a Bessou locometer, manual dexterity using the nine hole peg test, Static and dynamic postural stability test will be performed in both conditions “eyes open” and “eyes closed” using the SATEL® force platform, 6 Minute Walk Test (6 MWT) will be performed with measuring heart rate (HR) and "Pulsed" oxygen saturation using Pulse oximeter - SpO2 saturometer. - Change in biological parameters :The complete blood count with Phenotyping of sub-leukocyte populations (Monocytes, lymphocytes), extraction of messenger RNA from blood mononuclear cells, change in neuronal growth factors (brain derived neurotropic factor and GDNF), change in blood glucose and lipid profile (Total Cholesterol (TC), High-density lipoprotein (HDL), Low density lipoprotein (LDL) and Triglycerides (TG)), 8-Change in inflammation: pro-inflammatory cytokines (IL-17, INF-γ, IL-6, tumor necrosis factor…), reactive C protein, Change in hormones: Serum melatonin, Testosterone, Estrogen, Progesterone, Cortisol and Insulin concentrations, change in vitamins levels: D, E and A, 48 hours before and after intervention |
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| Ethics |
Ethics List |
26/12/2024 |
In response to the reviewer comment, I added an extension letter for the ethical approval to ensure its continued validity. |
TRUE, Committee of Protection of Persons in south, Road Manzel Cheker, Sfax, 3029, Tunisia, , 28 Sep 2019, +21674464858, wiembenamar@yahoo.fr, 11114_11502_4737.pdf |
TRUE, Committee of Protection of Persons in south, Road Manzel Cheker, Sfax, 3029, Tunisia, , 28 Sep 2019, +21674464858, wiembenamar@yahoo.fr, 11114_11502_4737.pdf |
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Date
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Reason
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| Collaborators |
Collaborators List |
03/03/2023 |
This researcher was not available to collaborate with us during the protocol |
Hachicha Hind, Road Tunis, Sfax, 3029, Tunisia |
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Collaborators List |
03/03/2023 |
This researcher was not available to collaborate with us during the protocol |
Turki Mouna, Afran , Sfax, , Tunisia |
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Collaborators List |
03/03/2023 |
Sorry, I forgot to cite this collaborator |
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Dana jallouli, Afran, Sfax, , Tunisia |
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Collaborators List |
03/03/2023 |
We collaborated with this researcher during the experimental protocol |
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Rim Kammoun, El Ain, Sfax, , Tunisia |
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Collaborators List |
03/03/2023 |
We collaborated with this researcher during the experimental protocol |
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Rami maaloul, Gremda, Sfax, , Tunisia |
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Collaborators List |
03/03/2023 |
We collaborated with this researcher during the experimental protocol |
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Mariem Damak, El ain, Sfax, , Tunisia |
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Collaborators List |
03/03/2023 |
Sorry I forgot to cite this cololaborator |
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Walid Feki, El ain, Sfax, , Tunisia |
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| Contact People |
Contacs List |
12/04/2022 |
Sonda jallouli is the principal investigator |
Principal Investigator, Hammouda, Omar, Dr., omar_hammouda86@yahoo.fr, , +21652785747, Sidi mansour road, Sfax, , Tunisia, Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Sfax University Tunisia |
Principal Investigator, Jallouli, Sonda, Miss, sondajallouli58@gmail.com, , 44188641, Road gremda, Sfax, , Tunisia, Research laboratory of evaluation and management of musculoskeletal system pathologies |
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| Contact People |
Contacs List |
20/11/2024 |
Sonda jallouli is the principal investigator |
Principal Investigator, Jallouli, Sonda, Miss, sondajallouli58@gmail.com, , 44188641, Road gremda, Sfax, , Tunisia, Research laboratory of evaluation and management of musculoskeletal system pathologies |
Principal Investigator, Jallouli, Sonda, Miss, sondajallouli58@gmail.com, sonda.jallouli@isseps.usf.tn, 44188641, Road gremda, Sfax, , Tunisia, Research laboratory of evaluation and management of musculoskeletal system pathologies |
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| Contact People |
Contacs List |
12/04/2022 |
Omar Hammouda is the supervisor of the sutdy |
Scientific Enquiries, Turki , Mouna, Mrs., mouna.turk@gmail.com, , +21622135609, Afran Road, Sfax, , Tunisia, Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Sfax University Tunisia |
Scientific Enquiries, Hammouda, Omar, Dr., omar.hammouda@parisnanterre.fr, , 33782931995, 200 Avenue of the Republic, 92000 Nanterre, Nanterre, , France, Research Laboratory Molecular bases of Human Pathology LR19ES13 |
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| Reporting |
IPD description |
25/08/2024 |
An error has occurred |
All of individual participant data will be collected during the trial, after deidentification
|
Individual data participant that underlie the results reported in this study will be shared on request after deidentification (text, tables or figures) |
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Section Name
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Field Name
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Date
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Old Value
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Updated Value
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| Reporting |
IPD-Sharing time frame |
25/08/2024 |
An error has occured and prevented me from saving this section. |
2 years
|
Data will be made available 2 years after the articles publication
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
IPD-Sharing time frame |
25/08/2024 |
An error has occurred |
Data will be made available 2 years after the articles publication
|
Data will be made available 3 years after the articles publication. No end date.
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Date
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| Reporting |
Key access criteria |
25/08/2024 |
An error has occured and prevented me from saving this section. |
key for all participant
|
Researchers who provide a methodologically sound proposal. They have to send their proposals to sondajallouli58@gmail.com or sonda.jallouli@isseps.usf.tn
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Field Name
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Date
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Reason
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Old Value
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| Reporting |
Key access criteria |
25/08/2024 |
An error has occurred |
Researchers who provide a methodologically sound proposal. They have to send their proposals to sondajallouli58@gmail.com or sonda.jallouli@isseps.usf.tn
|
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. They have to send their proposals to sondajallouli58@gmail.com or sonda.jallouli@isseps.usf.tn. To gain access, requestors will need to sign a data access agreement.
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| Reporting |
Study protocol document |
25/08/2024 |
An error has occured and prevented me from saving this section. |
Study Protocol, Statistical Analysis Plan, Informed Consent Form |
Study Protocol, Statistical Analysis Plan |