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CTRI Number  CTRI/2024/11/076570 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Other 
Public Title of Study   Exploring the Impact of Blood Flow Restriction Training on Fitness and Strength in Inactive College Students: A Pilot Study  
Scientific Title of Study   Efficacy of Blood Flow Restriction Training on VO2Max, BMI and Muscle Strength among physically Inactive Collegiate population-A Pilot Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanya Gujral 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  Plot No.2, Sector 17-A, Yamuna Expressway, Gautam Buddha Nagar, Greater Noida, Uttar Pradesh 203201

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9311020220  
Fax    
Email  gujraltanya14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Yashoda 
Designation  Student 
Affiliation  Galgotias University 
Address  Plot No.2, Sector 17-A, Yamuna Expressway, Gautam Buddha Nagar, Greater Noida, Uttar Pradesh 203201

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8368211357  
Fax    
Email  yashodabist111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yashoda 
Designation  Student 
Affiliation  Galgotias University 
Address  Plot No.2, Sector 17-A, Yamuna Expressway, Gautam Buddha Nagar, Greater Noida, Uttar Pradesh 203201

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8368211357  
Fax    
Email  yashodabist111@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell Galgotias University 
 
Primary Sponsor  
Name  Galgotias University 
Address  Plot No.2, Sector 17-A, Yamuna Expressway, Gautam Buddha Nagar, Greater Noida, Uttar Pradesh 203201 
Type of Sponsor  Research institution 
 
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 Tanya Gujral  College Students  Plot no.2, Sector 17A Yamuna Expressway Greater Noida Gautam Buddha Nagar Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH 		 9311020220

gujraltanya14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee,Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Physically inactive population. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blood Flow Restriction Training   3 times a week for a period of 4 weeks. 
Comparator Agent  Blood Flow Restriction Training  3 times a week for a period of 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Both the genders of age group 18 to 25 years
Physical inactive student as assessed by IPAQ
Nonsmoker
subjects who were independent in their daily activities.
 
 
ExclusionCriteria 
Details  BMI less than 18 OR more than 40.
The subjects with the presence of any blood anticoagulant medicine, peripheral vascular disease
Diabetes, hypertension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Queen Step Test   4 week 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   22/11/2024 
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="0"
Months="3"
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 explores the impact of Blood Flow Restriction Training (BFRT) at 40% Arterial Occlusion Pressure (AOP) on VO2max, BMI, and muscle strength in physically inactive college students. Physical inactivity is linked to numerous health risks, including heart disease, diabetes, and various cancers. Despite WHO’s recommendations of 150 minutes of moderate physical activity per week, a significant percentage of young adults remain inactive.

BFRT has gained popularity due to its ability to improve strength and cardiovascular fitness with lower-intensity workouts. This study specifically targets sedentary college students, aiming to fill gaps in existing BFRT research, which often focuses on older adults or athletes. The hypothesis suggests that BFRT at 40% AOP will improve VO2max, BMI, and muscle strength.

Objectives:
  1. To evaluate the efficacy of BFRT on VO2max.
  2. To evaluate the efficacy of BFRT on BMI and waist-hip ratio.
  3. To evaluate the efficacy of BFRT at 40% AOP on muscle strength. 
Methodology:
The study will involve 60 inactive students, divided into an experimental group receiving BFRT and a control group. Each group will participate in a 4-week training program, with assessments taken before and after. Methods for measurement include a 1.5-mile run for VO2max, BMI index calculation, waist-hip ratio measurement, and muscle strength testing via a dynamometer.

Intervention:  3 times a week for a period of 4 weeks.

This research seeks to validate BFRT’s effectiveness in enhancing fitness levels, promoting cardiovascular health, and building muscle strength among college students, aiming to address sedentary behavior in this demographic.
 
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