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.: PACTR202001780376483 Date of Approval: 28/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Blood Flow Restriction Exercises n Hamstring Strength, Bulk and Flexibility In Amateur Male Footballers.
Official scientific title Effect of Blood Flow Restriction Exercises n Hamstring Strength, Bulk and Flexibility In Amateur Male Footballers.
Brief summary describing the background and objectives of the trial Background: Football is a vigorous, high intensity contact sport. Research on sports injuries show high injury incidence rates for football, with male amateur soccer players being particularly prone to injury while hamstring injuries have been found to be the most common soccer-related muscle injury. Blood flow Restriction exercises may have effect on muscle bulk, strength and flexibility. Objectives: This study investigated the effect of blood flow restriction exercises on hamstring muscle strength, bulk and flexibility in amateur male footballers. Method: 41 amateur male footballers participated in this study. They were recruited from the National Stadium, Surulere, Lagos and College of Medicine, University of Lagos Staff School Sports Centre, Nigeria. Participants were randomly assigned into two groups using fish bowl method. 1 repitition maximum (RM) of each participant was determined using the leg curl. The first group (BFR group) took part in resistance and flexibility exercises with an aneroid sphygmomanometer and restriction pressure set 100mmhg. The second group (CTRL group) took part in conventional resistance and flexibility exercises. Data was analyzed using descriptive statistics of mean and standard deviation. Inferential statistics of paired t-test was done, level of significance was set at p<0.05. Results: The findings of this study showed significant improvement in all the hamstring parameters assessed (p<0.05) in the BFR group and CTRL group. There were also more significant improvements in hamstring parameters in the BFR group when compared with the CTRL group. Conclusion: Blood flow restriction exercises have an effect on hamstring muscle strength, bulk and flexibility in amateur male footballers. Keywords: 1 Repetition Maximum, Amateur male footballers, Blood flow restriction exercise, Hamstrings muscle, Nordic Hamstring Exercise, Sit-and-Reach Hamstring exercise.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 21/09/2019
Actual trial start date
Anticipated date of last follow up 25/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 41
Actual target sample size (number of participants)
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling 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
Experimental Group Blood flow restriction exercises 3 sessions (3 sets for each exercise) in a week for 12 weeks 12 weeks In the first group which is the BFR group the exercise protocol was explained to them and potential detrimental effects of the exercise if not done properly was explained to them. 1 repitition maximum (RM) of each participant was determined using the leg curl. The BFR group took part in hamstring curl exercises with an aneroid sphygmomanometer with the restriction pressure set 100mmhg (Yasuda et al 2009; Yasuda et al 2011; Kilgas et al, 2019). Training intensity and volume was set at 20-30% of 1-RM and 30 repetitions (3 sets of 10 reps, with 2–3 min of rest between sets). They also carried out flexibility exercises (SRH exercise) and the NHE while using the BFR cuff. For the NHE, participants started in a kneeling position on the exercise mat, with the torso from the knees upward held rigid and straight. The ankles were secured immediately superior to the lateral malleolus by the research assistant. The research assistant ensured that the feet were in contact with the ground throughout the exercise by applying pressure to the player’s heels/lower legs. The participant then lowered his upper body to the ground, as slowly as possible to maximize loading in the eccentric phase. Hands and arms were used to break forward fall and to push him back up after the chest has touched the ground, to minimize loading in the concentric phase. For the SRH exercise, the participants sat on an exercise mat with both legs out straight. The athlete then extended their arms and tried to reach forward by bending at the waist as far as possible while keeping the knees straight. The athlete held this position for 15 to 30 seconds and then relaxed back into the starting position and then repeated twice with 2–3 min of rest between the sets. Each BFR exercise session lasted for approximately 20 minutes. 21
Control Group Conventional exercises 3 sessions ( 3 sets of each exercise) in a week for 12 weeks. 12 weeks CTRL group, the resistance training, NHE and SRH exercise protocols were explained to them and potential detrimental effects of the exercises if not done properly were also explained to them. 1 repitition maximum (RM) of each participant was determined using the leg curl. Training intensity and volume was set at 60-80% of 1-RM and 30 repetitions (3 sets of 10 reps, with 2–3 min of rest between sets). For the NHE, participants started in a kneeling position on the exercise mat, with the torso from the knees upward held rigid and straight. The ankles were secured immediately superior to the lateral malleolus by the research assistant. The research assistant ensured that the feet were in contact with the ground throughout the exercise by applying pressure to the player’s heels/lower legs. The participant then lowered his upper body to the ground, as slowly as possible to maximize loading in the eccentric phase. Hands and arms were used to break forward fall and to push him back up after the chest has touched the ground, to minimize loading in the concentric phase. For the SRH exercise, the participants sat on an exercise mat with both legs out straight. The participant then extended their arms and tried to reach forward by bending at the waist as far as possible while keeping the knees straight. The athlete held this position for 15 to 30 seconds and then relaxed back into the starting position. 30 repetitions (3 sets of 10 reps, with 2–3 min of rest between sets) of NHE were carried out while SRH exercise was carried out for 3 sets, with 2–3 min of rest between sets. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants included in the study were: i. Amateur male footballers who had no history of hamstring injury currently or within the last 6 months. ii. Amateur male footballers who were neither hypertensive nor hypotensive. iii. Amateur male footballers without a history of deep vein thrombosis. Participants to be excluded from the study were: i. Amateur male footballers with physical disability. ii. Amateur male footballers who were living with cognitive disability or could not respond to commands and instructions. iii. Amateur male footballers who were currently diagnosed or had a recent history of cardiac disease. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 12 Year(s) 44 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 21/10/2019 College of Medicine University of Lagos Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi- Araba, Lagos. Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hamstring muscle strength, bulk and flexibility Beginning and end of intervention
Secondary Outcome Hamstring muscle bulk Beginning and end of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
College of Medicine University of Lagos Staff school sports center Idi- Araba, Lagos Lagos Nigeria
National Stadium Surulere Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Faminu John Adeyinka College of Medicine University of Lagos Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faminu John Adeyinka College of Medicine University of Lagos Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. A I Aiyegbusi Department of Physiotherapy, College of Medicine University of Lagos. Lagos Nigeria
Dr. O A FAPOJUWO Department of Physiotherapy, College of Medicine University of Lagod Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John Faminu Oluwademiladefam@gmail.com +2348132616747 College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria MSc Physiotherapy
Role Name Email Phone Street address
Scientific Enquiries Ayoola Aiyegbusi Bogphysio@gmail.com +2348184078287 Department of Physiotherapy, College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries John Faminu Oluwademiladefam@gmail.com +2348132616747 College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria MScPT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article after deidentificaton (text, tables, figured, appendices) will be provided. Informed Consent Form,Study Protocol Beginning 9 months and ending 36 months after date of publication. Data will be made available
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