| CTRI Number |
CTRI/2024/04/066259 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of One-Time Blood Flow Restriction Exercise on Muscle Size and Heart Health |
|
Scientific Title of Study
|
Efficacy of single bout Exercise in blood flow restriction training on Elbow Flexors in terms of muscle girth & Cardiovascular response |
| 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 |
GALGOTIAS UNIVERSITY |
| 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 |
TANYA GUJRAL |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GALGOTIAS UNIVERSITY |
| 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
Public Query
|
| Name |
TANYA GUJRAL |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GALGOTIAS UNIVERSITY |
| 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 |
|
|
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 International
Circuit, 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 No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9311020220
gujraltanya14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
30 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BLOOD FLOW RESTRICTION TRAINING |
Students of Galgotias University will be selected for this study via snowball sampling. Before initiation of the study, subjects will complete a Screening questionnaire. A clear explanation will be given to the subjects about the procedure and written consent will be obtained. All 30 subjects will undergo low intensity BFRT. Assessment of forearm girth will be done using a measuring tape positioned 10 cm distal to the midpoint between the lateral epicondyle and olecranon process in centimeters. Systolic and diastolic blood pressure will be measured using an automatic Oscillo metric device in mmHg (Omron Hem 7113, São Paulo, Brazil. For all subjects, systolic and diastolic blood pressures will be assessed after 10-minute passive rest period on arrival at the laboratory and 60 min after the administration of Low intensity-BFRT. Measurements will be performed in a seated position on the left arm consistent with the recommendations of the International Society of Hypertension.
The pneumatic blood pressure cuff will be placed on the upper arm, 4 cm proximal to the antecubital fossa in dominant limb. During the training this blood pressure cuff will be inflated to 50 mmHg to ensure venous occlusion. Exercise training will involve gripping a digital hand dynamometer and contracting the muscle at a rate of 15 times per minute by an electronic metronome, and a resistance of 20% of 1RM. The subjects will be trained for 20 min and will be allowed to take 1 min rest periods, after the completion of 4 min of training during which the cuff will be deflated. The load used was 20% of 1RM as per the standard guidelines of BFRT.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
.College students within range of 18 to25
.Subject with no complain of elbow pain
.Subject who do not have any history of upper extremity injury.
.Subject who are independent in their daily activities |
|
| ExclusionCriteria |
| Details |
. Subjects having past surgical history of upper extremity
.Subjects having any medical history of musculoskeletal upper extremity trauma. |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Muscle Girth and Blood Pressure |
Baseline,For all subjects, blood pressures and girth will be assessed after 10-minute passive rest period on arrival at the laboratory and 60 min after the administration of Low intensity-blood flow restrcition training |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to increase muscle girth |
The load used was 10-20% RM and the restrictions time was 5min per exercise was done on unilateral upper limb, 2 set were done with 15reps each. Rest iven between set was 20second. The restriction form was continuous |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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 Yet Recruiting |
| 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
|
BFRT was developed by SATO in Japan in 1966. Blood Flow Restriction
(BFR) training is a technique that combines low intensity exercise with blood
flow occlusion that produces similar results to high intensity training. It permits compression of the limb
using compression cuffs to limit venous outflow and minimize arterial inflow
during rehabilitation training.
OBJECTIVE:
By allowing an individual to lift smaller loads and increase strength training
gains, blood flow restriction can lessen the overall stress exerted on the
limb. This study’s prime aim will be to assess the difference in BP after a single
bout of BFRT and determine the effectiveness of the training and also to
evaluate the difference in terms of muscle girth after a single bout of muscle
girth.
METHODOLOGY: This is a , single-site, pilot study.Total of
30 subjects enrolled(16 female and 14 males) between the age group 18 to 25
years. Outcome measures will be muscle girth measured using flexible tape and
blood pressure using a an automatic
oscillometric device (Omron Hem 7113, São Paulo, Brazil). This study will be conducted at the
Department of Physiotherapy at Galgotias University. The ethical clearance is obtained from Departmental Ethics Committee of Galgotias University. |