| CTRI Number |
CTRI/2025/11/097336 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Blood flow restriction therapy on enhancement of performance in recreational runners |
|
Scientific Title of Study
|
Effect of Blood flow restriction therapy on muscle fatigue and performance in recreational runners |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAURABH SHARMA |
| Designation |
MPT, STUDENT |
| Affiliation |
Amity institute of physiotherapy, Amity Institute of Health Allied Science |
| Address |
Amity University, Noida, Sector-125, Uttar Pradesh, 201313, India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9315005216 |
| Fax |
|
| Email |
ss8375941118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Head of institution, Professor |
| Affiliation |
Amity institute of physiotherapy, Amity Institute of Health Allied Science |
| Address |
Amity University, Noida, Sector-125, Uttar Pradesh, 201313, India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Head of institution, Professor |
| Affiliation |
Amity institute of physiotherapy, Amity Institute of Health Allied Science |
| Address |
Amity University, Noida, Sector-125, Uttar Pradesh, 201313, India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Noida, sector-125, Uttar Pradesh, 201313, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Jasobanta Sethi |
Amity University |
Outpatient Department of Physiotherapy, Gate Number 1, Sector-125, Noida, Uttar Pradesh, 201313, India
Gautam Buddha Nagar
UTTAR PRADESH |
99886 00462
jsethi@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Recreational Runners |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Flow restriction therapy |
The present study aims to determine the effect of Blood Flow Restriction (BFR) training on muscle fatigue and physical performance in recreational runners. Participants will undergo a 6-week training program, where one group performs low-load resistance exercises under BFR and the other follows a standard exercise protocol without restriction. The outcomes will be assessed through parameters such as running performance (12-minute Cooper test), muscle fatigue (lactate levels), leg strength (1-RM test), lower limb endurance (single-leg sit-to-stand test), and circumference measurements.
The study seeks to identify whether low-load BFR training can provide similar or superior benefits to traditional high-load training while being safer, time-efficient, and joint-friendly. If effective, this protocol can help clinicians and coaches implement evidence-based BFR programs to enhance endurance, reduce fatigue, and improve performance in recreational runners. |
| Comparator Agent |
standard protocol |
standard protocol for recreational runners for strength, endurance and fatigue assessment by lactate analyser |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
1. Males between the ages of 20 and 35
2. Recreational runners (those who have been jogging on average three times per week for at least six months).
3. No known cardiovascular, neuromuscular, or musculoskeletal disorders.
4. No participation in BFRT or similar occlusion training protocols in the past 3 months. (to eliminate the carry-over effect)
5. Willingness to comply with the 6-week training protocol and testing schedule.
|
|
| ExclusionCriteria |
| Details |
1. Any existing lower-limb injury, chronic pain or recent surgery
2. Those who have already sustained lower limb injuries.
3. Subjects who were hypertensive (greater than 130 by 80 mm Hg).
4. Those who are taking GH, anabolic steroids.
5. Vascular health problems (deep vein thrombosis, varicose veins)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Running performance (distance measured)
Muscle fatigue (Lactate Analyzer)
Leg strength
Lower limb endurance
lower limb Circumference measurement
|
baselines, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Leg strength
Lower limb endurance
lower limb Circumference measurement
|
baselines, 3 weeks, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
25/11/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The present study aims to determine the effect of Blood Flow Restriction (BFR) training on muscle fatigue and physical performance in recreational runners. Participants will undergo a 6-week training program, where one group performs low-load resistance exercises under BFR and the other follows a standard exercise protocol without restriction. The outcomes will be assessed through parameters such as running performance (12-minute Cooper test), muscle fatigue (lactate levels), leg strength (1-RM test), lower limb endurance (single-leg sit-to-stand test), and circumference measurements. The study seeks to identify whether low-load BFR training can provide similar or superior benefits to traditional high-load training while being safer, time-efficient, and joint-friendly. If effective, this protocol can help clinicians and coaches implement evidence-based BFR programs to enhance endurance, reduce fatigue, and improve performance in recreational runners. |