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CTRI Number  CTRI/2024/04/066332 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Exploring the Impact of Varied Occlusion Pressure in Resistance Training on Hand Grip Strength and Forearm Girth in Young Adults: A Preliminary Investigation 
Scientific Title of Study   Effect of Resistance Training with Different Occlusion Pressure on Hand Grip Strength and Forearm Girth among Young Adults-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  TANYA GUJRAL 
Designation  ASSISTANT PROFESSOR 
Affiliation   
Address  Room No B-315, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9311020220  
Fax    
Email  gujraltanya14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  TARUN KUMAR 
Designation  BPT SCHOLAR 
Affiliation  GALGOTIAS UNIVERSITY 
Address  Room No B-304, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203021
India 
Phone  09311020220  
Fax    
Email  kumartarun0307@gmail.com  
 
Details of Contact Person
Public Query
 
Name  TARUN KUMAR 
Designation  BPT Student 
Affiliation  Galgotias University 
Address  Room No B-304, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203021
India 
Phone  9311020220  
Fax    
Email  kumartarun0307@gmail.com  
 
Source of Monetary or Material Support  
Research and Development cell, Room No B-316, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar 
 
Primary Sponsor  
Name  Research and Development cell Galgotias University 
Address  ROOM No A 315, Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha Internataional Cicuit, Greater Noida 
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  GALGOTIAS UNIVERSITY  Room No E-004, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No2, Sector 17A, Opposite Buddha International Circuit, Greater Noida Gautam Buddha Nagar
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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  30 Subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Resistance Training with Different Occlusion Pressure   In this study we will compare the effect of different occlusion pressure on hand grip strength and forearm girth using dynamometer. This study will be done on healthy subjects. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Subjects aged between 18-25 years, Both males and female subjects
Subjects with no previous strength training experience
of upper extremity in past 6 months. 
 
ExclusionCriteria 
Details  History of recent fracture, muscle strain and ligament sprain of upper limb in past 6 months
History of cardiovascular, metabolic,orthopedic and neurological disease, active infection,Risk for
adverse responses to exercise; and/or taking any medication such as anabolic steroid
Any congenital deformity of upper extremity. 
 
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 
Muscle strength using digital dynamometer.  On day 1 and day 12 it will be tested 
 
Secondary Outcome  
Outcome  TimePoints 
Forearm girth using inch tape.  On day 1 and day 12 it will be tested 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 3 
Date of First Enrollment (India)   04/06/2024 
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="2"
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 current study aims to investigate the impact of varying restrictive pressures during resistance training, considering that existing guidelines recommend cuff pressure to be within the range of 40-80% of Arterial Occlusion Pressure (AOP). However, there is a gap in the literature regarding whether the Arterial Occlusion Pressure should remain constant throughout the entire protocol or if variations in pressure could yield different outcomes. This study seeks to address this knowledge gap and provide insights into the optimal approach for cuff pressure adjustments during resistance training.

This research will look at the optimal occlusive pressure required during strength training to improve forearm girth and muscle strength. It will therefore offer an alternative to modified resistance training for a more effective and quick recovery. It will assist exercise physiologists, physiotherapists, and trainers in creating a safe, effective, and workable program for increasing muscle strength and size in those who cannot tolerate high-intensity training regimens. Therefore, the study’s objective is to investigate how young adults’ muscle strength and muscle girth were affected by resistance training at a moderate intensity combined with blood flow restriction.


 
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