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CTRI Number  CTRI/2025/09/094111 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Impact of Blood Flow Restriction Training on Breathing Ability in Adults Who Exercise Regularly 
Scientific Title of Study   Effects of Blood Flow Restriction Training on Pulmonary Function among Recreationally Active Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jobandeep Singh 
Designation  Assistant professor 
Affiliation  lovely professional University  
Address  Department of Physiotherapy lovely professional University

Kapurthala
PUNJAB
144401
India 
Phone  7901779034  
Fax    
Email  jobandeep2866@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jobandeep Singh 
Designation  Assistant professor 
Affiliation  lovely professional University  
Address  Department of Physiotherapy lovely professional University

Kapurthala
PUNJAB
144401
India 
Phone  7901779034  
Fax    
Email  jobandeep2866@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jobandeep Singh 
Designation  Assistant professor 
Affiliation  lovely professional University  
Address  Department of Physiotherapy lovely professional University

Kapurthala
PUNJAB
144401
India 
Phone  7901779034  
Fax    
Email  jobandeep2866@gmail.com  
 
Source of Monetary or Material Support  
Cardiopulmonary laboratory, Department of physiotherapy, Khalsa College, Amritsar, Punjab 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Varinder Kaur   Khalsa College, Amritsar  Cardiopulmonary Physiotherapy laboratory Ground floor
Amritsar
PUNJAB 		 8437243887

varinderkaur4187@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee, Department of physiotherapy, Khalsa college Amritsar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adults undergoing pulmonary function assessment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blood flow restriction training   Group A (Control): 15 to 20 minutes of cycling exercise including warm-up and cool-down. Group B (BFRT): Same cycling exercise with proximal thigh blood flow restriction cuffs inflated at 100 to 150 mmHg, including warm-up and cool-down. Both groups will train three times per week for four weeks. 
Comparator Agent  Conventional low-intensity cycling exercise  Participants will perform 15–20 minutes of cycling exercise including warm-up and cool-down, three times per week for four weeks, without blood flow restriction. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Male 
Details  Male subjects aged 15 to 25 years.
Individuals who have been attending the gym for at least 6 months.
Participants who are free from hypertension, musculoskeletal disease, hyperlipidemia, cardiopulmonary disease, peripheral vascular disorders, and neurological imbalances involving lower limbs.
Willing to participate and able to perform the prescribed bicycle ergometer exercise protocol. 
 
ExclusionCriteria 
Details  Female participants.
Age below 15 or above 25 years.
Individuals not regularly attending the gym or with less than 6 months of gym experience.
Participants with any of the following conditions:
Hypertension
Musculoskeletal disorders
Hyperlipidemia
Cardiopulmonary disease
Peripheral vascular disorders
Neurological imbalances involving lower limbs
Participants unable or unwilling to perform the exercise protocol or follow study procedures.
Participants with contraindications to blood flow restriction training, such as clotting disorders or vascular injury  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
FVC (Forced Vital Capacity)
 		 Baseline & 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Peak Expiratory Flow Rate (PEFR)
Peak Inspiratory Flow Rate (PIFR) 		 Baseline & 4 weeks  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/09/2027 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study investigates the effects of blood flow restriction training BFRT on muscle strength thigh girth and pulmonary function in young male gym goers. Forty healthy male participants aged 15 to 25 years with at least six months of gym experience will be recruited from gyms in Amritsar. Participants will be randomly divided into two groups of 20 each. Group A control will perform 15 to 20 minutes of cycling exercise and Group B BFRT will perform the same cycling exercise with proximal thigh blood flow restriction cuffs inflated at 100 to 150 mmHg. Both groups will train three times per week for four weeks. Pre and post intervention assessments will include thigh girth and pulmonary function spirometry. Pulmonary function will be assessed using a spirometer in a seated position with visual feedback. The study aims to evaluate whether BFRT provides additional benefits over conventional low intensity exercise for muscle and pulmonary health in young adults. 
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