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.: PACTR202203813725635 Date of Approval: 16/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE COMBINED EFFECTS OF WALKING FOOTBALL AND INTERMITTENT FASTING ON CARDIOVASCULAR, METABOLIC AND BIOCHEMICAL RESPONSES IN SUBJECTS LIVING WITH METABOLIC SYNDROME.
Official scientific title THE COMBINED EFFECTS OF WALKING FOOTBALL AND INTERMITTENT FASTING ON CARDIOVASCULAR, METABOLIC AND BIOCHEMICAL RESPONSES IN SUBJECTS LIVING WITH METABOLIC SYNDROME.
Brief summary describing the background and objectives of the trial The cultural factors and changes have influenced eating styles and physical activity levels, and have contributed to metabolic syndrome (MetS) epidemics in the world. That poses significant risks to public health. Recent studies have concluded that intermittent fasting has positive health effects. It is time-efficient and does not require strict control of the amount of food consumed. Intermittent fasting is sufficient to respect the periods of food intake to expect beneficial results. Moreover, the association between fasting and exercise could equilibrate more the energy balance and induce greater biological adaptation (i.e., autophagy, increased insulin sensitivity, increased heart rate variability, decreased blood pressure, decreased inflammation). These are some common advantages of exercise and fasting. Otherwise, recreational exercise has been recently considered as much better than prescribed intensity ones. Moreover, it has been concluded that explicit recommendations for self-paced exercise may improve adherence to exercise programs among adults with metabolic diseases (e.i obesity, diabetes, hypertension ...). The objective of the present study was to examine the acute and chronic (3 months) effects of walking football practice, combined with an intermittent fasting, on the physiological and biochemical responses as well as the physical and cognitive performance in adults living with a metabolic syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 15/03/2022
Actual trial start date
Anticipated date of last follow up 15/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
0336 Comettee for the protection of persons from the south
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Alternate fasting day Alternate day fasting (2 days/week). 3 months Subjects needed to take a light meal before sunrise, no food and drink on the day was allowed (approximately for 13 h) and a complete meal after sunset. 20
Experimental Group walking Football 3 sessions per week, with one hour per session. 3 months 3 Walking football matches per week. Each match begins with a 5 minute warm-up, followed by two 20 minute periods of play, separated by a 10 minute recovery period. 20
Experimental Group Walking football training combined with fasting 3 sessions per week (1 hour/session) alternate day fasting (2 days/week) 3 months 3 Walking football matches per week. Each match begins with a 5 minute warm-up, followed by two 20 minute periods of play, separated by a 10 minute recovery period. In addition, volunteers fast two days a week, provided that it is on a different day than the training day. 20
Control Group Control 3 months During the intervention phase, the control group will continue their sedentary lifestyle and will undergo only the evaluation tests. 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Subjects over 45 years of age - Updated sanitary control - IMC > 25 - Less than 2 hours of physical activity per week Two additional metabolic syndrome diagnostic criteria (ATP III Definition): - HDL <40 mg/dl - Triglyceride >150 mg/dl - Fasting glucose >110 mg/dl - Blood pressure >135/80 mm Hg - Use of anabolic steroids, or beta-blockers - The presence of another chronic or acute disease (e.i Chronic pulmonary diseases, Neurological disorders, Kidney failure.) - Musculotendinous or osteoarticular injuries or Chondropathie. - High-risk cardiovascular diseases (angina pectoris, heart failure, ventricular arrhythmias, or myocardial infarction). Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 65 Year(s) Male
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 29/09/2021 Committee for the Protection of Persons SUD
Ethics Committee Address
Street address City Postal code Country
Avenue Majida BOULILA, 3029 Sfax Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome RPE rating of perceived exertion scale during exercise (6 [lowest] to 20 [highest] points): The RPE scale is used to measure the intensity of the exercise Immediately after each walking football session
Primary Outcome Heart rate during exercise : To keep heart rate variability under control during exercise and prevent the risk of cardiovascular events. during exercise
Primary Outcome Distance (km): Assessed using GPS tracking during exercise during exercise
Primary Outcome Acute effect of: • Glycemic • Lactate • Oxygen saturation Change between before and immediately after each exercise session
Primary Outcome Acute systolic and diastolic blood pressure effect Change between before and immediately after each exercise session
Primary Outcome Biochemical parameter: • inflammatory markers • Oxidative stress Before and after a walking football session
Secondary Outcome Anthropometric measurements: Body Mass Index (BMI), Waist circumference... before and after 3 months of training
Secondary Outcome Body composition: Body fat, Body lean mass.. before and after 3 months of training
Secondary Outcome Cardiovascular parameter: ECG Recording, Blood pressure, Heart rate variability before and after 3 months
Secondary Outcome Physical parameter: - push-ups - Number of squats - Hand Grip Test - Lumbar strength - Y-balance test - Modified Agility T-test - 6 minutes’ walk test before and after 3 months
Secondary Outcome Psycho-cognitive parameters: - Profile of mood states test (Poms) - FatigueScale - TRS / TRC - Sleep assessment before and after 3 months of training
Secondary Outcome Biochemical parameter: - Oxidative stress markers - Inflammatory markers - Urinary tests - Alanine-Amino-Transferase - Hormones tests - Metabolic markers before and after 3 months of training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
High institut of sports and physical activity of Sfax Airport Road, Km 3,5, BP 384 Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Centre International d Etude du Sport CIES Avenue DuPeyrou 1 Neuchatel 2000 Swaziland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre International d Etude du Sport CIES Avenue DuPeyrou 1 Neuchatel 2000 Swaziland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Hamdi Chtourou Road Airport Sfax Tunisia
Achref Ammar Saarstr. 21 Mainz Germany
Semah Tagougi 42 Road Paul Duez Lille France
Mouna Turki Sfax Sfax Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sami HIDOURI samihidouri4@gmail.com +21627974272 Omrane city - Manzel bouzaienne
City Postal code Country Position/Affiliation
Sidi Bouzid 9114 Tunisia Research Laboratory Education Motricity Sport and health LR19JS01 High Institute of Sport and Physical Education of Sfax Tunisia
Role Name Email Phone Street address
Scientific Enquiries Omar Hammouda hammouda.o@parisnanterre.fr +21652785747 Sidi Mansour
City Postal code Country Position/Affiliation
sfax Tunisia Research Laboratory Molecular Bases of Human Pathology LR19ES13 Faculty of Medicine University of Sfax Tunisia
Role Name Email Phone Street address
Public Enquiries Noureddine Kammoun noureddine.kammoun8@gmail.com +21695174612 sfax
City Postal code Country Position/Affiliation
sfax Tunisia Research Laboratory Education Motricity Sport and health LR19JS01 High Institute of Sport and Physical Education of Sfax Tunisia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trial, after identification Informed Consent Form After publication Key for all participant
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