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CTRI Number  CTRI/2024/11/077082 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The Impact of Heavy Weight Training combined with Blood Flow Restriction on Leg Strength in Recreational Male Bodybuilders 
Scientific Title of Study   Effect of High Load Resistance Training with Blood Flow Restriction on lower limb muscle Strength in Recreational Male Bodybuilders 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himanshu Mishra 
Designation  PG Student MPT Sports 
Affiliation  Indian Spinal Injuries Center - Institute of Rehabilitation Sciences (ISIC-IRS) 
Address  2nd Floor - Indian Spinal Injuries Center - Institute of Rehabilitation Sciences (ISIC-IRS), Sector C, Vasant Kunj

South
DELHI
110070
India 
Phone  9953193783  
Fax    
Email  himanshumishra868@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sadhan Berry (PT) 
Designation  Associate Professor 
Affiliation  Indian Spinal Injuries Center - Institute of Rehabilitation Sciences (ISIC-IRS) 
Address  2nd Floor - Indian Spinal Injuries Center - Institute of Rehabilitation Sciences (ISIC-IRS), SECTOR C, Vasant Kunj

South
DELHI
110070
India 
Phone  9818098441  
Fax    
Email  sadhan27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Himanshu Mishra 
Designation  PG Student MPT Sports 
Affiliation  Indian Spinal Injuries Center - Institute of Rehabilitation Sciences (ISIC-IRS) 
Address  2nd Floor - Indian Spinal Injuries Center - Institute of Rehabilitation Sciences (ISIC-IRS), Sector C, Vasant Kunj

South
DELHI
110070
India 
Phone  09953193783  
Fax    
Email  himanshumishra868@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Center - Institute of Rehabilitation Sciences (ISIC-IRS), Sector C, Vasant Kunj, New Delhi - 110070 
 
Primary Sponsor  
Name  Dr Sadhan Berry PT 
Address  2nd Floor - Indian Spinal Injuries Center - Institute of Rehabilitation Sciences (ISIC-IRS), SECTOR C, Vasant Kunj 
Type of Sponsor  Other [Self] 
 
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 Himanshu Mishra PT  champ fitshala  champ fitshala, jain nagar, sector 38, rohini, new delhi
North West
DELHI 
9953193783

himanshumishra868@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INDIAN SPINAL INJURIES CENTER - INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  RECREATIONAL BODYBUILDERS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  High Load Resistance Training (HLRT)  Group B (HLRT) - Athletes will engage in routine high-load resistance training of the lower limb. Duration of this study will be 6 months in which 8 weeks intervention would be provided to bodybuilders. In 8 weeks 16 sessions will be done and each session would last for approximately 45 - 60 minutes in which 4 set of exercise will be done. Each set would be of 5-10 min with 5 min of rest between sets.  
Intervention  High Load Resistance Training with Blood Flow Restriction (HLRT+BFR)  Group A (HLRT+BFR) - Athletes will engage in high-load resistance training of the lower limb while wearing a blood flow restriction cuff at 60% occlusion pressure of athletes individual arterial occlusion pressure (AOP). Duration of this study will be 6 months in which 8 weeks intervention would be provided to bodybuilders. In 8 weeks 16 sessions will be done and each session would last for approximately 45 - 60 minutes in which 4 set of exercise will be done. Each set would be of 5-10 min with 5 min of rest between sets in which cuff will be deflated.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  1. The participants who regularly involve in weightlifting and strength training for at least last 6 months.
2. Strength training experience: minimum 2 years
3. Physical Activity Readiness Questionnaire (PARQ) should be negative

 
 
ExclusionCriteria 
Details  1. Any lower limb surgery since last 6 months.
2. Any diagnosed Cardiovascular disorder since last 6 months.
3. Any lower limb injury or disorder since last 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Lower limb muscle strength  At the end of 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
Lower limb circumference  At the end of 8th week 
 
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   N/A 
Date of First Enrollment (India)   01/12/2024 
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="6"
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  

This study, titled "Effect of High Load Resistance Training with Blood Flow Restriction on Lower Limb Muscle Strength in Recreational Male Bodybuilders," will aim to investigate whether combining High Load Resistance Training (HLRT) with Blood Flow Restriction (BFR) can enhance muscle strength and circumference, potentially helping bodybuilders overcome the training plateaus often encountered at advanced levels. The study will involve 30 male bodybuilders aged between 20 and 30 years, each with a minimum of two years of strength training experience. Participants will be divided into two groups using a random allocation method. Group A will undergo HLRT combined with BFR, while Group B will receive only traditional HLRT. The primary objective of this research will be to measure changes in quadriceps and hamstring muscle strength, using a dynamometer, and muscle circumference, using a retractable measuring tape, over an 8-week intervention period. Measurements will be taken at baseline and at the end of the 8-week intervention. The study will test the hypothesis that the combined HLRT-BFR method may lead to significant improvements in muscle strength and circumference compared to HLRT alone. Descriptive statistics will be used to summarize the collected data, and appropriate statistical tests (e.g., t-tests or Mann-Whitney U-tests, depending on normality) will be performed to compare results between and within the two groups. Statistical significance will be set at p<0.05. The study is expected to last for six months and will provide new insights into optimizing strength training techniques for recreational male bodybuilders. If successful, the findings could offer evidence-based recommendations for athletes seeking to break through performance plateaus using innovative training methods like HLRT combined with BFR.

 
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