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CTRI Number  CTRI/2024/07/070972 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   The Impact of Blood Flow Restriction (BFR) Training and Variable Repetition Duration (VRD) Training on strength, endurance, Power, and Girth among Fitness Enthusiasts. 
Scientific Title of Study   Effect of Blood Flow Restriction (BFR) Training and Variable Repetition Duration (VRD)Training on Physical Performance Parameters in Fitness Enthusiasts: An Experimental Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
-  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarfraznawaz F Shah 
Designation  Professor 
Affiliation  College of Physiotherapy 
Address  Dept. of Musculoskeletal & Sports College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University, At.Po. Pipariya, Ta. Waghodia, Dist. Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9724005599  
Fax    
Email  sfsphysiophd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Mukkamala 
Designation  Professor 
Affiliation  College of Physiotherapy 
Address  College of Physiotherapy Dept. of Musculoskeletal & Sports Sumandeep Vidyapeeth Deemed to be University, At.Po. Pipariya, Ta. Waghodia, Dist. Vadodara
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University, At.Po. Pipariya, Ta. Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India 
Phone  9898216184  
Fax    
Email  neha.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Neha Mukkamala 
Designation  Professor 
Affiliation  College of Physiotherapy 
Address  College of Physiotherapy Dept. of Musculoskeletal & Sports Sumandeep Vidyapeeth Deemed to be University, At.Po. Pipariya, Ta. Waghodia, Dist. Vadodara
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University, At.Po. Pipariya, Ta. Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India 
Phone  9898216184  
Fax    
Email  neha.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
College of Physiotherapy Dept. of Musculoskeletal & Sports Sumandeep Vidyapeeth Deemed to be University, At. Post. Pipariya, Ta. Waghodia, Dist. Vadodara 391760 
 
Primary Sponsor  
Name  Sarfraznawaz F Shah 
Address  College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University, At.Po. Pipariya, Ta. Waghodia, Dist. Vadodara 391760 
Type of Sponsor  Other [Self Funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarfraznawaz F Shah  Baroda Football Academy  B/9 - B/32, Diamond Complex, Fatehgunj, Baroda 390002
Vadodara
GUJARAT 		 9724005599

sfsphysiophd@gmail.com 
Dr Sarfraznawaz F Shah  Gujarat State Kabaddi Association  Swami Nivas, A-10, Shree Kunj Bunglows, Near Vadsar Bridge, Bhat Kuva, Manjalpur, Vadodara
Vadodara
GUJARAT 		 9724005599

sfsphysiophd@gmail.com 
Dr Sarfraznawaz F Shah  Sumandeep Vidyapeeth Deemed To be University  At.Po. Pipariya, Ta. Waghodia, Dist. Vadodara
Vadodara
GUJARAT 		 9724005599

sfsphysiophd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Baroda Football Academy  No Objection Certificate 
Gujarat State Kabaddi Association  No Objection Certificate 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blood Flow Restriction (BFR) Training  Exercise 1: Squats Weeks 1-2 (Adaptation Phase): Warm-up: 5-10 minutes of light aerobic activity 5 Min – Brisk Walking 5 Min – Active Stretching & Foam Rolling Exercise 1: Perform 3 sets of squats with BFR cuffs/bands applied at 50-60% of limb occlusion pressure (LOP). Repetitions: 15-20 reps per set at 20-30% of 1RM Rest between sets: 30-60 seconds. Additional Endurance Component: Will include 15 minutes of low-intensity cardiovascular exercise (brisk walking) at the end of each BFR training session to promote endurance adaptations. Cool-down: 5-10 minutes of static stretching for major muscle groups. 5 Min – Active Stretching 5 Min – Foam Rolling Weeks 3-4 (Progression Phase): Warm-up: 5-10 minutes of light aerobic activity. 5 Min – Brisk Walking 5 Min – Active Stretching & Foam Rolling Increase intensity by performing 4 sets of squats with BFR cuffs/bands applied at 60-65% of LOP. Repetitions: 12-15 reps per set at 30% of 1 RM for squats Rest between sets: 45-90 seconds. Will include 18 minutes of low-intensity cardiovascular exercise (brisk walking) at the end of each BFR training session to promote endurance adaptations. Cool-down: 5-10 minutes of static stretching. 5 Min – Active Stretching 5 Min – Foam Rolling Weeks 5-6 (Peak Performance Phase): Warm-up: 5-10 minutes of light aerobic activity. 5 Min – Brisk Walking 18 5 Min – Active Stretching & Foam Rolling Perform 4 sets of squats with BFR cuffs/bands applied at 65-70% of LOP. Repetitions: 10-12 reps per set at 40% of 1 RM for squats, Will include 20 minutes of low-intensity cardiovascular exercise (brisk walking) at the end of each BFR training session to promote endurance adaptations. Rest between sets: 60-120 seconds. Cool-down: 5-10 minutes of static stretching. 5 Min – Brisk Walking 5 Min – Active Stretching & Foam Rolling  
Comparator Agent  NIL  NIL 
Intervention  Variable Repetition Duration (VRD) Training  Exercise: Loaded Back Squat Weeks 1-2: Adaptation Phase Session Frequency: 3 sessions per week. Sets and Repetitions: Slow Eccentric/Fast Concentric: 4 sets of 10 reps. Moderate Tempo: 4 sets of 10 reps. Weeks 3-4: Strength Development Phase Session Frequency: 3 sessions per week. Sets and Repetitions: Slow Eccentric/Fast Concentric: 4 sets of 8 reps. Fast Eccentric/Slow Concentric: 4 sets of 8 reps. Weeks 5-6: Power and Endurance Focus Session Frequency: 3 sessions per week. Sets and Repetitions: Fast Eccentric/Slow Concentric: 4 sets of 6 reps. Constant Tempo: 4 sets of 12 reps. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  - Fitness enthusiasts actively engaged in regular exercise or sports activities (e.g.,resistance training, running, cycling, etc.) (150mins/week)
- Participants with no history of cardiovascular or musculoskeletal disorders that would contraindicate BFR training.
- Participants willing to commit to a 6-week structured training program consisting of BFR and VRD training.
- Participants with no prior experience with BFR training or similar occlusion techniques.
- Ability to understand and follow the study protocols and instructions provided by the research team.
- Willingness to provide informed consent to participate in the study 
 
ExclusionCriteria 
Details  - Individuals with a history of cardiovascular diseases, hypertension, or other medical conditions that may pose a risk during BFR training.
- Participants with musculoskeletal injuries or conditions that would limit their ability to perform exercise safely.
- Pregnant or breastfeeding women due to potential risks associated with BFR training.
- Individuals currently using medications or supplements that may affect exercise performance or cardiovascular responses.
- Participants with a known allergy or sensitivity to materials used in BFR cuffs or bands.
- Athletes or individuals participating in high-intensity training programs that may interfere with the study outcomes.
- Individuals with a history of thrombotic disorders or blood clotting abnormalities.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Repetition Maximum (RM) for Strength
 		 At Baseline
At 3 weeks
At 6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
12 min Cooper’s Walk / Run Test  3 Times 
Girth Measurement
 		 3 Times 
Vertical Jump Test  3 Times 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   N/A 
Date of First Enrollment (India)   29/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 comparative analysis of Blood Flow Restriction (BFR) training and Variable Repetition Durations (VRD) training among fitness enthusiasts addresses a significant gap in existing literature by directly comparing these two popular training modalities. BFR and VRD training have individually demonstrated benefits in enhancing athletic performance, but a direct comparison is essential to determine their relative efficacy for specific performance outcomes. This study aims to optimize training protocols by evaluating the effects of BFR and VRD training on strength, power, hypertrophy, and endurance. An Experimental Study will be conducted involving healthy male and female participants aged 18-30 years who engage in regular exercise. Participants will be divided into BFR and VRD training groups, with training protocols implemented over six weeks. Outcomes will be measured using 1RM, vertical jump test, girth measurement, and the Cooper 12-Minute Run/Walk Test. The study’s findings will provide evidence-based recommendations for incorporating BFR and VRD training into athletic and fitness programs, contributing to the broader scientific understanding of these training methods and their practical applications. 
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