| 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
|
|
|
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
|
|
|
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.
|