| CTRI Number |
CTRI/2025/03/081781 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study about sport specific training in football players with Blood flow restriction on strength. |
|
Scientific Title of Study
|
Effect of sport-specific training with Blood flow restriction on functional ability in male Football players - A Randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukesh kumar R |
| Designation |
Assistant professor |
| Affiliation |
MGM institute of Physiotherapy |
| Address |
MGM institute of Physiotherapy, Department of sports Physiotherapy. no.3, MGM institute of Physiotherapy, N-6, CIDCO, Chh sambhaji nagar
Department of sports Physiotherapy. no.3, MGM institute of Physiotherapy, N-6, CIDCO, Chh sambhaji nagar
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9677273370 |
| Fax |
|
| Email |
mukeshbpt0312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sandhiya |
| Designation |
Assistant professir |
| Affiliation |
Vels institute of science and technology |
| Address |
School of Physiotherapy, Vels institue of science and technology Thazhambur
Chennai
TAMIL NADU
600130
India |
| Phone |
9940583928 |
| Fax |
|
| Email |
sandhiya.sp@velsuniv.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Sandhiya |
| Designation |
Assistant professir |
| Affiliation |
Vels institute of science and technology |
| Address |
School of Physiotherapy, Vels institue of science and technology Thazhambur
Akola
TAMIL NADU
600130
India |
| Phone |
9940583928 |
| Fax |
|
| Email |
sandhiya.sp@velsuniv.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of sports physiotherapy, MGM institute of Physiotherapy, Chh Shambaji nagar |
|
|
Primary Sponsor
|
| Name |
Mukesh kumar R |
| Address |
Department of sports Physiotherapy. no.3, MGM institute of Physiotherapy, N-6, CIDCO, Chh sambhaji nagar |
| Type of Sponsor |
Other [this study is sponsored by the principal investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R Mukesh kumar |
MGM Institute of Physiotherapy |
Department of Sports physiotherapy, MGM institute of Physiotherapy, Department, C Building, MGM, N-6, CIDCO, Chh. Sambhaji Nagar
Aurangabad
MAHARASHTRA |
9677273370
mukeshbpt0312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VISTAS Institutional Ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Football players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sport-specific training and Blood flow restriction |
Subjects in this group will perform all training activities between the warm-up and cooldown with custom-made Blood Flow Restriction cuffs applied around their proximal thighs. These devices consisted of a rubber pneumatic cuff (40-cm long; 4-cm wide) inside a thick linen cloth (50-cm long; 5-cm wide), with the cuff inflation and arterial occlusion pressure quantified using Handheld Doppler at the Dorsalis pedis artery. The duration of the study is 8 weeks.
|
| Comparator Agent |
Sports specific training |
Subjects in this group will perform Sports specific training without blood flow restriction training for duration of 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Male |
| Details |
1)Subjects with more than 3 years of playing experience.
2)An answer to “no” to all questions in Australian Institute of Sport science (AIS) BFR pre-screening questionnaire6.
|
|
| ExclusionCriteria |
| Details |
1) any history of deep vein thrombosis
2) Body mass Index more than 30 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Repetition maximum |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vertical jump height |
8 weeks |
| Yo-Yo Intermittent recovery test |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Randomised controlled trial which will have two groups, and both will receive Sports specific training. Group A (experimental group) will receive Sports specific training with Blood flow restriction and Group B will receive sports specific training alone. Subjects in the Blood flow restriction group will perform all training activities between the warm-up and cooldown with custom-made BFR cuffs applied around their proximal thighs. These devices consisted of a rubber pneumatic cuff (40-cm long; 4-cm wide) inside a thick linen cloth (50-cm long; 5-cm wide), with the cuff inflation and arterial occlusion pressure quantified using Handheld Doppler at the Dorsalis pedis artery.
|