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CTRI Number  CTRI/2024/04/066415 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Exploring the Impact of Blood Restriction using bands Among Young Obese Females 
Scientific Title of Study   Effect of Blood Flow Restriction Aerobic Training on Body Composition, Cardiorespiratory Performance and Quality of Life in Young Obese Females 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumera Khan 
Designation  PhD Scholar 
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  7827777195  
Fax    
Email  ksphysio487@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sumera Khan 
Designation  PhD Scholar 
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


UTTAR PRADESH
203201
India 
Phone  7827777195  
Fax    
Email  ksphysio487@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-319, 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  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell,Galgotias University Room no C201, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India, 203201 
 
Primary Sponsor  
Name  Galgotias University 
Address  Plot No 2, Sector 17A, Opposite Buddha International circuit, 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 Sumera Khan  Department of Physiotherapy, Galgotias University  Room No E003, OPD Physiotherapy Department, Plot No 2, Sector 17A, Opposite Buddha International circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 7827777195

ksphysio487@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Ethics Committee, Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aerobic Training  All participants after taking informed consent will undergo aerobic training with 50% of Heart Rate Reserve for 15 minutes per session twice weekly with 3 repititions each set for a total duration of 12 weeks. 
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 restrcition with 80% of Arterial occlusion pressure at 50% of Heart rate reserve twice weekly for 15 minutes with 2 sets of 3 repititions each for a total duration of 12 weeks with a rest period of 1 minute in between each set. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  BMI Grade I between 30-34.9 kg/m2
Prior to the commencement of the study, none of the participants had engaged in regular strength, resistance, and/or aerobic exercise  
 
ExclusionCriteria 
Details  Body mass index – more than Grade I
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 
Body Mass Index
Muscle strength and endurance by Dynamometer
Heart Rate, BP, Vo2 Max by PFT(FVC,FEV1 and ratio)
SPo2
Blood Glucose and lactic Acid Profile
 		 Baseline and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
WHOQOL- BRIEF  Baseline, 6 months and 12 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="220" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/05/2024 
Date of Study Completion (India) 07/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ksphysio487@gmail.com].

  6. For how long will this data be available start date provided 09-05-2025 and end date provided 09-05-2033?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study investigates the effects of Blood Flow Restriction (BFR) Aerobic Training on various parameters in young obese females. It explores changes in body composition, cardiorespiratory performance, and quality of life 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. 
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