| CTRI Number |
CTRI/2024/11/076477 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Understanding the Effects of Different Blood Pressure Levels on Inactive People |
|
Scientific Title of Study
|
Effect of Blood Flow Restriction Technique with Treadmill Walking on Cardiopulmonary Function and Muscle Strength among Sedentary Young Adults- A Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Tanya Gujral |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
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
203201
India |
| Phone |
9311020220 |
| Fax |
|
| Email |
gujraltanya14@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Kamran Ali |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
B-BLOCK, 3rd Floor, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203021
India |
| Phone |
95406 86786 |
| Fax |
|
| Email |
kamran.ali@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Tanya Gujral |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
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
203201
India |
| Phone |
9311020220 |
| Fax |
|
| Email |
gujraltanya14@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Research and Development Cell, Galgotias University Room no C-013, Plot No 2, Sector 17A,
Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh,
203201, India |
|
Primary Sponsor
Modification(s)
|
| Name |
GALGOTIAS UNIVERSITY |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tanya Gujral |
GALGOTIAS UNIVERSITY |
E-004,Department of
Physiotherapy, SAHS
Galgotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9311020220
gujraltanya14@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sedentary Young Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Flow Restricting Training
Group |
All participants after screening and taking the informed consent will be educated and informed
about the whole procedure. They will receive aerobic training with blood flow restriction with 40%, 60% & 80% of Arterial occlusion pressure at 40-59% Heart Rate Reserve |
| Comparator Agent |
Only Aerobic Training |
Group A will perform treadmill walking without BFR cuff(control group),group B will perform blood flow restricted treadmill walking with 0% arterial occlusion pressure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with BMI ranging from 18.5 to 24.9 (non-obese).
Subjects with score of less than 600 metabolic equivalent (MET) per week on The International Physical Activity Questionnaire.
University students based in different zones of Delhi.
|
|
| ExclusionCriteria |
| Details |
Any recent Musculoskeletal injury of the lower limb
Peripheral vascular disorders
Any Metabolic disorder
Bone and joint disease.
Anyone already undergoing aerobic & Resistance training
Neuropsychological disorders
Recent Myocardial infarction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate
Blood pressure
Rate pressure product
Pulmonary function-FEV1and FVC
Vo2 Max
Measurement of knee extensors peak force |
Baseline and at the end of 4th to 5th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Thigh girth measurement
Body Mass Index |
Baseline and at the end of 4th to 5th week |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
11/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 investigates the effects of different Blood Flow Restriction (BFR) Aerobic Training on various parameters in young sedentary adults. It explores changes in body composition, cardiorespiratory performance resulting from this novel exercise approach. Through controlled interventions, the research aims to elucidate the potential benefits of BFR training in improving health outcomes among this demographic. By analyzing data on body composition shifts, cardiovascular endurance enhancements, and subjective assessments of well-being, the study aims to provide insights into the efficacy of BFR aerobic training as a potential strategy for managing obesity-related health concerns in young females. The aim of the study is to evaluate the effect of blood flow restriction technique with treadmill walking on cardiopulmonary function and muscle strength among sedentary young adults. |