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.: PACTR202112545675734 Date of Approval: 17/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of the Ramadan fast on the coping profile of Tunisian male professional footballers
Official scientific title The effect of the Ramadan fast on the coping profile of Tunisian male professional footballers
Brief summary describing the background and objectives of the trial The objective of our study was to assess the effect of Ramadan fasting on the coping profile among Tunisian professional male footballers. 180 footballers belong to 12 Tunisian professional clubs: (age: 25.54 ± 4.41 years, weight: 77.19 ± 5.99 kg; height: 180.54 ± 7.28 cm ; BMI : 23.67±0.58), were tested during three sessions: one month before Ramadan, during the fourth week of Ramadan and one month after Ramadan. In each session, subjects responded to the Arabic version of the Competitive Sport Coping Strategy Inventory (ICSCS). Responses were retrospectively registered one to two hours after an official competition.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 19/12/2019
Actual trial start date 19/12/2019
Anticipated date of last follow up 10/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group CG 5 months Technical and physical training 180 Placebo
Experimental Group EG 5 months EG has followed a training program in motor imagery 180
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must: 1) be professional footballers; 2) systematically participate in official competitions in the first and second professional Tunisian leagues. They were recruited because they say they are ready to fast for the entire month of Ramadan be professional footballers, not registered in the national football championship will not fast during the whole month of Ramadan Adult: 19 Year-44 Year 18 Year(s) 37 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 05/12/2019 south people protection committee SOUTH CPP
Ethics Committee Address
Street address City Postal code Country
Sfax Sfax 3000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Le jeûne du Ramadan a un effet négatif sur le profil d'adaptation des footballeurs professionnels tunisiens. Les stratégies d'adaptation utilisées à T1 et T3 sont différentes de celles utilisées à T2. les strategies du coping utlilisées à T2 sont instables par rapport acelles utilisées à T1 et T2. T1: before Ramadan / T2: in the last week of Ramadan / T3: after Ramadan
Primary Outcome Ramadan fasting has a negative effect on the adaptation profile of Tunisian professional footballers. The coping strategies used at T1 and T3 are different from those used at T2. coping strategies used at T2 are unstable compared to those used at T1 and T2. T1: before Ramadan / T2: in the last week of Ramadan / T3: after Ramadan
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
12 Tunisian professional football clubs 1003 Tunis Tunis 1003 Tunisia
professional football clubs league 2 1002 Tunis Tunis 1002 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jamal Haji Gafsa Gafsa 2100 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Higher institute of sports and physical education Gafsa Gafsa 2100 Tunisia University
Secondary Sponsor Tunisian Football Federation Tunis Tunis 1003 Tunisia Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
ECUMUS laboratory University of Sfax Sfax 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jamel Hajji hajji5jamel@yahoo.fr 0021654253492 Gafsa
City Postal code Country Position/Affiliation
Gafsa 2100 Tunisia higher institute of sports and physical education of gafsa
Role Name Email Phone Street address
Public Enquiries Ali Elloumi alielloumi62@gmail.com 0021698439025 Sfax
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia Sfax Faculty of Letters and Human Sciences
Role Name Email Phone Street address
Scientific Enquiries Sofien Fekih fkih2007@hotmail.com 0021625942041 Msaken
City Postal code Country Position/Affiliation
Sousse 4054 Tunisia higher institute of sports and physical education of gafsa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the data collected during the study will be published with the test Study Protocol Informed consent form, study protocol Free access will be allowed to obtain the data, please send an e-mail to hajji5jamel@yahoo.fr
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