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.: PACTR202004720204308 Date of Approval: 17/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of FIFA 11+ Warm Up Program on Fatigue, Sleep Quality, Muscle Flexibility and Psychological Status among Amateur Footballers in Lagos State
Official scientific title Effect of FIFA 11+ Warm Up Program on Fatigue, Sleep Quality, Muscle Flexibility and Psychological Status among Amateur Footballers in Lagos State
Brief summary describing the background and objectives of the trial A footballer undergoes high levels of physical demands which may lead to fatigue, decreased performance, sleep deprivation and consequently problem with their psychological status (Tarobi-Nami, 2011; Lastella et al, 2012; Bengtsson, 2013). Attaining an appropriate balance between training and competition stresses is important to boosting the performance of athletes (Barnett, 2006). In achieving optimal athletic performance, athletes must follow a systematic approach to training centered on the fundamental principle of the “training response” (Pearce, 2002). This focuses on obtaining a balance between stress, fatigue, and recovery, termed the stress/fatigue state (Bird, 2011). This state is described as a psychosociophysiological phenomenon with psychological, social, and physiological factors recognized to have the greatest impact on this state (Kentta and Hassmen, 1998; Jeffreys, 2005). The “FIFA 11+” warm up program was developed with the aim of preventing common injuries in football which include ankle and knee sprains and muscle strains (Brito, 2010; Daneshjoo, 2013; Impellizzeri, 2013). It was developed by the FIFA Medical Assessment and Research Centre (F-MARC) (Owoeye et al, 2014). It is a complete warm-up program of dynamic and specific exercises combining cardiovascular activation and preventive neuromuscular exercises (Soligard, 2008; Bizzini et al, 2011). Despite the main goal of the “FIFA 11+” being injury prevention, the knowledge of training effects obtained by this program can help in identifying the potential mechanisms behind its efficacy and whether players may obtain added performance benefits other than injury prevention (Franco, 2013). Some studies have examined the effects of “FIFA 11+” on various performance parameters but there is dearth in literature about its effect on fatigue, sleep quality, flexibility and psychological status (Impellizzeri et al, 2013; Costa Silva, 2015). This study is therefore designed to study the effect of “FIFA 11+” warm up program on fatigue, sleep quality, muscle flexibility and psychological status among amateur footballers in Lagos state.
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,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 07/10/2019
Actual trial start date 21/10/2019
Anticipated date of last follow up 01/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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
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 FIFA 11 plus warm up program Twice a week for 20 minutes 4 weeks The “FIFA 11+” program takes an average of 20 minutes to complete and consists of three parts: (i) running exercises at a low speed, intercalated with active stretching and partner contact where the running course includes six to ten pairs of cones (depending on the number of players) about five to six meters apart (length and width); (ii) six different sets of exercises, including strength, plyometrics and balance, each with three levels of increasing difficulty; (iii) running exercises at moderate speed combined with specific football movements, with constant change of direction. All 27 exercises focus on core stability, neuromuscular control, agility, and eccentric hamstring strength 20
Control Group Regular team Warm up exercise Twice a week for 20 minutes 4 weeks Participants in this group will maintain the normal warm-up routine of the club which include a combination of running, stretching, technical exercises with the ball and games, matching its duration to that of the “FIFA 11+” (20 minutes). 20 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Only registered amateur footballers. Non- football players. Amateur footballers who have stopped playing football. Amateur footballers with sport injury. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 30 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 21/11/2019 Health Research Ethics Committee College of Medicine of the University of Lagos Nigeria
Ethics Committee Address
Street address City Postal code Country
College of Medicine of the University of Lagos Idiaraba, Lagos, Nigeria. Lagos 00234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fatigue Baseline, 2nd week and 4th week
Secondary Outcome Sleep quality Baseline, 2nd week and 4th week
Primary Outcome Muscle flexibility Baseline, 2nd week and 4th week
Primary Outcome Psychological status Baseline, 2nd week and 4th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mountain of Fire and Miracles ministries Football Club 13 Olasimbo street, Onike, Iwaya, Yaba Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Oluwasanmi Adesanya 7 Kayode Falowo street, Magodo Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oluwasanmi Adesanya College of Medicine University of Lagos Idi Araba Lagos Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR A.K. AKODU COLLEGE OF MEDICINE UNIVERSITY OF LAGOS, IDI ARABA LAGOS Nigeria
DR. U.A.C. OKAFOR UNIVERSITY OF LAGOS, COLLEGE OF MEDICINE LAGOS Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwasanmi Adesanya sanmi.adesanya@gmail.com +2348168518336 7 kayode falowo street, Magodo
City Postal code Country Position/Affiliation
Lagos Nigeria College of Medicine University of Lagos
Role Name Email Phone Street address
Public Enquiries Oluwasanmi Adesanya Sanmi.adesanya@gmail.com +2348168518336 7 kayode falowo street Magodo
City Postal code Country Position/Affiliation
Lagos Nigeria College of Medicine University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Ashiyat Akodu akoduashiyat@gmail.com +2348034269053 College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Senior lecturer College of Medicine University of Lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date. FIFA 11+, WARM-UP, FATIGUE, SLEEP QUALITY, MUSCLE FLEXIBILITY, PSYCHOLOGICAL STATUS, AMATEUR
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