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.: PACTR202208826495102 Date of Approval: 22/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Therapeutic effect of one session of physical activity combined with melatonin supplementation after myocardial infarction
Official scientific title Acute effect of one session of physical activity combined with nocturnal ingestion of melatonin on cardiovascular adaptations and sleep quality after myocardial infarction treated by primary percutaneous coronary intervention
Brief summary describing the background and objectives of the trial Following myocardial infarction (MI), the reperfusion of the ischemic tissues by the primary coronary intervention is essential to salvage ischemic areas. However, reperfusion itself causes further tissues damages, the basic pathophysiology of ischemic reperfusion injury especially oxidative stress. The absence of oxygen and nutrients from blood during the ischemic period creates a condition in which the restoration of blood flow results in inflammation and increase of reactive oxygen species (ROS) rather in normal function. The excessive production of ROS can lead to a mitochondrial and endothelial dysfunction with a reduced cardiac output by the myocardium cell death. In addition, oxidative stress induces an increase of the sympathetic nervous system activity. It is well demonstrated that one session of physical activity has a benefic effect on cardiovascular system; a decrease in blood pressure and heart rate (cardio deceleration). In addition, exercise plays a major role in improvement of sleep quality by the biological clock regulation. It is well demonstrated that sleep disturbances observed in people with coronary artery diseases are due to the circadian misalignment by the decrease in nocturnal concentrations of melatonin (MEL), a neurohormone that regulates the biological clock. Moreover, MEL has a cardioprotective role due to its antioxidative, antiapoptotic, and anti-inflammatory actions. The aim of this study is to investigate the acute effect of intake of MEL on cardiovascular response after one session of exercise in patients after acute MI.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial supplementation
Anticipated trial start date 15/09/2022
Actual trial start date
Anticipated date of last follow up 15/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Crossover: all participants receive all interventions in different sequence 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 melatonin supplementation 10 mg one night In our study we will investigate the acute effect of one dose of melatonin supplementation after each session of exercise. Each participant will perform 2 sessions of physical training (strength+aerobic) intercepted by 48 hours for recovery (one with melatonin supplementation and the other with placebo; the order will be determined according to randomization) . Each participant will be assessed before the onset of the exercise session and after exercise. The exogenous melatonin will be taken 30 min before sleeping during the onset of exercise session. 20
Control Group placebo 10 mg one night In our study we will investigate the acute effect of one dose of melatonin supplementation after each session of exercise. Each participant will perform 2 sessions of physical training (strength+aerobic) intercepted by 48 hours for recovery (one with melatonin supplementation and the other with placebo; the order will be determined according to randomization) . Each participant will be assessed before the onset of the exercise session and after exercise. The placebo will be taken 30 min before sleeping during the onset of exercise session. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
acute myocardial infarction treated with percutaneous coronary intervention Chronic heart failure with left ventricular ejection fraction < 45% before the acute MI Recent valve surgery Musculoskeletal limitation Uncontrolled arrhythmia, hypertension, diabetes, or additional issues that would preclude potential participation in the program Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 26/05/2021 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 Rest heart rate , heart rate recovery , systolic and diastolic pressure, heart rate variability , quality of sleep evaluated by actigraphy before and after exercise and ingestion
Secondary Outcome Demographics and clinical characteristics , level of physical activity evaluated by Ricci and Gagnon questionnaire and International Physical Activity Questionnaire IPAQ only before ingestion and exercise session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of Cardiology University Hospital Center Hedi Chaker Road el Ain Km 0.5 Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Cardiology University Hospital Hedi Chaker Road Ain km 0.5 Sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of caridology University Hospital Hedi Chaker Road el Ain Km 0.5 Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Mona Turki Road Ain km 0.5 Sfax 3029 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ali Hbaieb mohamed.ali.hbaieb@univ-poitiers.fr +21694660000 Road Tunis Km 5
City Postal code Country Position/Affiliation
Sfax 3021 Tunisia PhD Student in Poitiers University and High 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 Tarak Driss tarak.driss@parisnanterre.fr +33636414400 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 Laurent Bosquet laurent.bosquet@univ-poitiers.fr +33549454115 15 Rue Hotel dieu
City Postal code Country Position/Affiliation
Poitiets 86000 France MOVE laboratory UR 20296
Role Name Email Phone Street address
Scientific Enquiries Salma Charfeddine selma_charfeddine@yahoo.fr +21698638435 Road el Ain Km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Department of cardiology University Hospital Hedi Chaker
Role Name Email Phone Street address
Public Enquiries Mohamed Ali Hbaieb mohamed.ali.hbaieb@univ-poitiers.fr +21694660000 Road Tunis km 5
City Postal code Country Position/Affiliation
Sfax 3021 Tunisia PhD student at University of Poitiers MOVE laboratory UR 20296
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