| CTRI Number |
CTRI/2025/02/081430 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Effects of 30% and 50% Blood Flow Restriction on Hand Grip Strength in Young College Students |
|
Scientific Title of Study
|
Effect of 30% and 50% Blood Flow Restriction on Hand Grip Strength of Young College Students |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Jaryal |
| Designation |
MPT |
| Affiliation |
LOVELY professional university |
| Address |
LPU OPD, 3rd block, School of Allied Medical Science, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT)road, Near Chaheru, Phagwara
Kapurthala
Kapurthala
PUNJAB
144411
India |
| Phone |
7986642053 |
| Fax |
|
| Email |
jaryalbhawna46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhawna Jaryal |
| Designation |
MPT |
| Affiliation |
LOVELY professional university |
| Address |
LPU OPD, 3rd block, School of Allied Medical Science, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT)road, Near Chaheru, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
7986642053 |
| Fax |
|
| Email |
jaryalbhawna46@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhawna Jaryal |
| Designation |
MPT |
| Affiliation |
LOVELY professional university |
| Address |
LPU OPD, 3rd block, School of Allied Medical Science, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT)road, Near Chaheru, Phagwara
Kapurthala
Kapurthala
PUNJAB
144411
India |
| Phone |
7986642053 |
| Fax |
|
| Email |
jaryalbhawna46@gmail.com |
|
|
Source of Monetary or Material Support
|
| LPU OPD, 3rd block, School of Allied Medical Science, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT)road, Near Chaheru, Phagwara
Kapurthala,
144411
Punjab
|
|
|
Primary Sponsor
|
| Name |
Bhawna Jaryal |
| Address |
lovely professional university GT road Jalandhar Punjab 144411 |
| 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 Bhawna Kumari |
Lovely Professional University, OPD Department of physiotherapy |
LPU OPD, 3rd block, School of Allied Medical Science, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT)road, Near Chaheru, Phagwara
Kapurthala
Jalandhar
PUNJAB |
7986642053
jaryalbhawna46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hand grip strengthening |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Flow Restriction Training (30% occlusion of blood flow) |
In this type of intervention, Blood Flow Restriction (BFR) pneumatic cuff will be applied to the proximal arm(non-dominant) with 30% of limb occlusion pressure, where the venous pressure is occluded completely and arterial pressure is occluded partially. Then, low-intensity hand strengthening exercises of the occluded limb with 20-30% of 1 Repetition Maximum will be performed by the subjects, 3 times a week for the duration of 6 weeks. |
| Comparator Agent |
Blood Flow Restriction Training (50% occlusion of blood flow) |
In this type of intervention, Blood Flow Restriction (BFR) pneumatic cuff will be applied to the proximal arm(non-dominant) with 50% of limb occlusion pressure, where the venous pressure is occluded completely and arterial pressure is occluded partially. Then, low-intensity hand strengthening exercises of the occluded limb with 20-30% of 1 Repetition Maximum will be performed by the subjects, 3 times a week for the duration of 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy population, with more than 3 months duration
18 and 26 year of age.
Gender Males and females
|
|
| ExclusionCriteria |
| Details |
Prior any surgery of hand.
Any hand Disorders.
Cardiac pacemaker.
History of blood clots or deep vein thrombosis.
History of cerebrovascular disease.
Sickle cell anemia.
Severe hypertension.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hand grip strength
Hand circumference
Forearm muscle girth
Forearm muscle girth
|
T1:2 times
T2:2 times
T3:2 times
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pinch Strength |
T1: 2 times
|
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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 2 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="1"
Months="0"
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
|
NEED OF STUDY To ascertain effectiveness of 30% and 50% of blood flow restriction training on hand grip strength. SIGNIFICANCE OF STUDY The study helps to to rule out the difference effect of between the two pressures that is 30% and 50%. With having different exercise of low resistance AIM OF STUDY Effect of 30% and 50% of pressure range of blood flow training on hand grip strength. OBJECTIVES OF STUDY Effectiveness of 30% of pressure range on hand grip strength. Effectiveness of 50% of pressure range on hand grip strength. Effectiveness of low resistance exercise by blood flow restriction on muscle mass and muscle strength. HYPOTHESIS NULL HYPOTHESIS There will be not be any significant effect of 30% and 50% blood flow restriction training on hand grip strength of young college students. ALTERNATE HYPOTHESIS There will be significant effect of 30% and 50% blood flow restriction training on hand grip strength of young college students. |