| 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
|
|
|
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
|
|
|
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. |