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.: PACTR202309885617364 Date of Approval: 01/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Therapeutic effect of physical and cognitive training combined with melatonin supplementation in subjects with mild to moderate Parkinson's disease.
Official scientific title The effect of physical activity and simultaneous cognitive enrichment coupled with melatonin supplementation on cognitive-motor performance and biochemical adaptations in subjects with mild to moderate Parkinson's disease.
Brief summary describing the background and objectives of the trial Parkinson's disease (PD) is a complex and progressive disease characterized by various motor and non-motor symptoms.Cardinal motor features include resting tremor, rigidity, bradykinesia, postural instability, and altered gait pattern including gait blockage. In addition to these motor symptoms, cognitive dysfunction is one of the most common non-motor comorbidities in patients with PD. Furthermore, sleep disturbances observed in people suffering from Parkinson disease are due to the circadian misalignment by the decrease in nocturnal concentrations of melatonin, a neurohormone that regulates the biological clock. Physical and cognitive exercise as an auxiliary method has few side effects, easy to do, economically beneficial, it has been proven to positively affect gait, posture control and cognitive functions including attention and executive functions of patients with PD. This is the first prospective study that investigate the effect of early neurological rehabilitation combined with melatonin supplementation in patients with early to moderate Parkinson's disease.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/04/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date 31/10/2023
Anticipated target sample size (number of participants) 55
Actual target sample size (number of participants) 45
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group simultaneous physical and cognitive exercice combined with melatonin supplementation Duration of the session: 1 hour Frequency of sessions: 3 hours / week 3 months Patients of this group will be included of neurological rehabilitation which is composed of physical and cognitive exercice simultaneously combined with a daily 5 mg of melatonin supplementation. 15
Experimental Group Patients of this group will be included of neurological rehabilitation which is composed of physical Duration of the session: 1 hour Frequency of sessions: 3 hours / week 3 months This group will not be subjected to any neurological rehabilitation program throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of 5 mg. 15
Control Group placebo daily 5mg of placebo supplementation 3 months This group will not be subjected to any neurological rehabilitation program throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of 5 mg. 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Have mild to moderate Parkinson's disease. • Be 50 or older. • Subjects not undergoing other types of physical or cognitive interventions. • Illiterate subjects. • With a chronic pathology that could affect their capacity for effort or the evaluation of walking parameters, balance or cycling: recent and/or unstable respiratory, neurological or musculoskeletal, cardiovascular pathologies ( e.g. heart attack, arrhythmia, angina pectoris, hypertension), insulin-dependent diabetes, or alcoholism or presenting contraindications to taking melatonin. • Advanced stage of Parkinson's disease. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 75 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 22/02/2023 COMITE DE PROTECTION DES PERSONNES SUD
Ethics Committee Address
Street address City Postal code Country
Bd Majida Boulila Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome physical performance evaluated by 10 m of walking test,postural balance by AMTI force plate,functional capacity measured by timed up and go,30 secondes sit to stand test and four square step test and cognitive performance evaluated by Montreal Cognitive Assessment (MoCA),Trail making test TMT-A,TMT-B,symbol digit modalities SDMT,verbal fluency,stroop test.Biochemial adaptations evaluated by oxidative stress and routine biochemical assessment. 90 days
Secondary Outcome sleep quality evaluated by Pittsburgh Sleep Quality Index (PSQI),quality of life by parkinson disease questionnaire PDQ-8,depression by Hospital Anxiety and Depression Scale. 90 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of Neurology University Hospital Habib Bourguiba Road el Ain Km 0.5 Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Neurology University Habib Bourguiba Road el Ain km 0.5 Sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Departement of Neurology University Habib Bourguiba Road el Ain km 0.5 Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Mouna Turki Road el Ain km 0.5 Sfax 3029 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Meryam ben yahia Meryambenyahia96@gmail.com +21629273751 road gremda km 2.5
City Postal code Country Position/Affiliation
Sfax 3032 Tunisia PhD Student at Higher Institute of Sport and Physical Education of Sfax
Role Name Email Phone Street address
Scientific Enquiries Omar Hammouda omar.hammouda@parisnanterre.fr +33782931995 Avenue of the Republic
City Postal code Country Position/Affiliation
Paris 92000 France Interdisciplinary Laboratory in Neurosciences Physiology and Psychology Physical Activity Health and Learning
Role Name Email Phone Street address
Scientific Enquiries Nouha Farhat nouhafarhat15@gmail.com +21658128254 Road el Ain Km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Department of Neurology University Habib Bourguiba
Role Name Email Phone Street address
Scientific Enquiries Sonda Jallouli sondajallouli58@gmail.com +21644188641 road gremda km3
City Postal code Country Position/Affiliation
Sfax 3032 Tunisia PhD Student at Higher Institute of Sport and Physical Education of Sfax
Role Name Email Phone Street address
Scientific Enquiries Ines Mezghani mezghani.ines916@gmail.com +21620774874 road el ain km0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia biochemistry department CHU Habib Bourguiba
Role Name Email Phone Street address
Public Enquiries Meryam Ben yahia Meryambenyahia96@gmail.com +21629273751 road gremda km2.5
City Postal code Country Position/Affiliation
Sfax 3032 Tunisia PhD Student at Higher Institute of Sport and Physical Education of Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data collected during the trial and after deidentification will be shared Informed Consent Form Data will be made available following publication. Access to data can be granted anyone who wishes to access it.
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