Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202005770507528 Date of Approval: 04/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of intra-dialytic combined strength-endurance training and melatonin supplementation on biochemical, immune and physiological responses (renal and cardiovascular function), physical capacity and quality of sleep in hemodialysis patients
Official scientific title The effect of intra-dialytic combined strength-endurance training and melatonin supplementation on biochemical, immune and physiological responses (renal and cardiovascular function), physical capacity and quality of sleep in hemodialysis patients
Brief summary describing the background and objectives of the trial The attempt to change sedentary behavior in the hemodialysis (HD) population is relatively recent in Tunisia, where dialysis centers rarely offer an exercise program as part of the primary prevention strategies for complications associated with HD. In this sense, the exercise performed during HD, namely intra-dialytic exercise, is an effective alternative to increase functional capacity, muscular strength, cardiovascular parameters and quality of life (Sheng et al., 2014). In addition, Melatonin is an endogenous hormone mainly synthesized and secreted by the pineal gland (Macchi & Bruce, 2004). Research has shown that melatonin not only regulates the circadian biological clock, but also serves a variety of biological functions (ie, antioxidant, inhibitor of sympathetic activity, preserves endothelial function, improves the bioavailability of NO, modulator of apoptosis and circadian modulator of vascular function) (Koch BC, 2010; Pinato L, 2013). Regarding renal function, Koch et al. (2010) observed that the deterioration of the latter is associated with a decrease in the production of melatonin. The effect of melatonin supplementation on immune function and inflammation, oxidative stress as well as hemodynamic balance and cardiovascular function is not yet studied in hemodialysis patients. Therefore, our study aims to study the effects of intra-dialytic combined training (strength-endurance) with melatonin supplementation on: - immune function and inflammation - oxidative stress - muscle damage - hemodynamic balance -vascular function -Postural stability - Isokinetic muscle strength - Aerobic capacity - Quality of life - Psychological state (anxiety and depression) - The quality of sleep
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/06/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 33
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control Group Three mg of placebo (Galpharma Laboratories, Sfax, Tunisia) 12 weeks Control group performing a conventional resting HD session with duration of 4 h without intradialytic exercise. 11 Placebo
Experimental Group Training group Three mg of MEL (Jamieson Laboratories, Toronto, Canada) for [Exercise+Melatonin group] or PLA (Galpharma Laboratories, Sfax, Tunisia) for [Exercise+Placebo] 12 weeks Exercise training was performed under the supervision of study personnel during the first 2 h of HD and composed of three phases: endurance training, resistance training and stretching. Before the HD session, the participant underwent active stretching of the lower limbs. Next, warm up was performed using a lower limb cycle ergometer which was positioned in front of the participantt for 5 minutes, and the participant was then submitted to aerobic training with an initial duration of 15 minutes. The duration was then gradually increased by 5 min during the first week and then by 10 min during the second week to reach 30 min after 2 weeks of training. Then, exercise duration was increased by 5–10% weekly (to a maximum of 60 min). Exercise was prescribed and controlled based on the participants heart rate using a target zone of 50 to 60% of the maximum heart rate (HRmax = 207–0.7 × age). Since many HD patients use beta-blockers, Borg’s rating of perceived exertion, was also used as a parameter of exercise intensity. Participants cycled at self-selected pace at an effort equivalent to 3-4 which corresponds to an intensity of “mild” to “quite hard”. During resistance exercise, starting weights for knee extension and hip abduction and flexion were determined from a three-repetition maximum (3RM). Training started at approximately 60% of 3RM for two sets of 10 repetitions and was increased to three sets as tolerated. When participants could perform three sets with correct technique, the weight was increased. The participant rested 1 min between the three sets of ten repetitions, and 3 min between the exercise categories. During the training session the intensity of exercise and vital signs were monitored every 5 min. After exercise, the lower limb stretching exercises were performed on the dialysis chair and directed to the following muscles: hamstring, hip adductors, hip abductors, tibialis anterior, gastrocnemius and soleus. 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patients on stable dialysis treatment (> 3 months on hemodialysis with adequate dialysis efficiency) (4 h / day, 3 days / week). -Aged between 20 and 60. -Body mass index (BMI) (kg⋅m - 2) between 18.5 and 24.9 The development of a serious condition requiring hospitalization or preventing exercise. -Participation in a physical rehabilitation program during the past year. - Orthopedic problems - Presence of chronic respiratory and cardiac diseases. -Thrombosis -Ischemic heart disease - Uncontrolled hypertension - Severe dyspnea Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2017 The south institutional human research ethics committee
Ethics Committee Address
Street address City Postal code Country
Hbib Bourguiba Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome - immune function and inflammation - oxidative stress - muscle damage - hemodynamic balance -vascular function -Postural stability - Isokinetic muscle strength - Aerobic capacity - Quality of life - Psychological state (anxiety and depression) - The quality of slee Before training and after training
Primary Outcome The height and body mass, body mass index Before intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nephrology department CHU Hedi Chaker Hedi Chaker street Sfax Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
CHU Habib Bourguiba El Ferdaouss street Sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Hbib Bourguiba street Sfax Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Omar Hammouda Airport street Sfax Tunisia
Hatem Masmoudi Hbib Bourguiba street Sfax Tunisia
Hend Hachicha Hedi Chaker street Sfax Tunisia
Mouna Turki Republic Street Sfax Tunisia
Jamil Hachicha Hedi Chaker Street Sfax Tunisia
Khawla Kammoun Hedi Chaker Street Sfax Tunisia
Abdelmonoem Yahia Hbib Bourguiba Street Sfax Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Hammouda Omar_hammouda86@yahoo.fr +21652785747 hedi Chaker street
City Postal code Country Position/Affiliation
Sfax Tunisia Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Sfax University Tunisia
Role Name Email Phone Street address
Public Enquiries Mouna Turki mouna.turki@gmail.com +21698338230 Hbib Bourguiba street
City Postal code Country Position/Affiliation
Sfax Tunisia Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Sfax University Tunisia
Role Name Email Phone Street address
Scientific Enquiries Samah Ghroubi sghroubi@yahoo.fr +21698289209 Republic Street
City Postal code Country Position/Affiliation
Sfax Tunisia The Research Unit of the assessment of musculoskeletal disorders UR12ES18 University of Sfax Tunisia.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes - immune and inflammation parameters - oxidative stress - muscle damage - hemodynamic balance -vascular function -Postural stability - Isokinetic muscle strength - Aerobic capacity - Quality of Life - Psychological state (anxiety and depression) - The quality of sleep Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 years Request access: controlled Type of data analysis: summary results Process for requesting data: By email Who will decide: Houssem marzougui Creteria for reviewing requests: Qualifications
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information