FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052454 [Registered on: 10/05/2023] Trial Registered Prospectively
Last Modified On: 09/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECTIVENESS OF BFRT ON PATIENTS WITH KNEE OSTEOARTHRITIS GRADE 2 
Scientific Title of Study   Effectiveness of low intensity Blood Flow Restriction Training on physiological and pathological factors in patients with osteoarthritis of knee grade 2 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himanshi Chaudhary 
Designation  Research scholar 
Affiliation  Manav Rachna International Institute of Research and Studies  
Address  Manav Rachna International Institute of Research and Studies Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  7291071412  
Fax    
Email  himanshi.chaudhary520@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankita Sharma 
Designation  Assistant professor 
Affiliation  Manav Rachna International Institute of Research and Studies  
Address  Manav Rachna International Institute of Research and Studies Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  8826395132  
Fax    
Email  ankitasharma.fas@mriu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Ankita Sharma 
Designation  Assistant professor 
Affiliation  Manav Rachna International Institute of Research and Studies  
Address  Manav Rachna International Institute of Research and Studies Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  8826395132  
Fax    
Email  ankitasharma.fas@mriu.edu.in  
 
Source of Monetary or Material Support  
ESIC hospital Faridabad 
Manav Rachna International Institute of research and studies 
 
Primary Sponsor  
Name  NONE 
Address  NONE 
Type of Sponsor  Other [NONE] 
 
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 Ankita Sharma  Manav Rachna International Institute of Research and Studies   Sector 43 Aravalli Hills Surajkund road
Faridabad
HARYANA 		 8826395132

ankitasharma.fas@mriu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHCAL COMMITTEE, DEPARTMENT OF ALLIED HEALTH SCIENCE, MRIIRS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BLOOD FLOW RESTRICTION TRAINING  The Low Intensity Blood Flow Restriction Training group will perform the exercises wearing an air cuff with a width of 175 mm and length of 920 mm that will be placed at the inguinal fold and inflated to provide a pressure of 70% required for complete BFR. The restriction to be maintained for all training sessions, including rest periods, and immediately to be released after the session is complete. The Low Intensity Blood Flow Restriction Training group will perform four sets of 15 repetitions at 20% of their 1-RM. Frequency- 3 times a week Exercises to be performed- Unilateral knee extension and flexion on leg extensor machine  
Comparator Agent  CONTROL GROUP  Training programme involving the High Intensity Strength Training group performs four sets of 10 repetitions at 50% of their 1-RM. Frequency- 3 times a week Exercises to be performed-Unilateral knee extension and flexion on leg extensor machine  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Age between 40-60 years
Diagnosed with unilateral knee OA according to the American College of Rheumatology criteria
Moderate to very severe (scores between 5 and 13 on the Lequesne Questionnaire)
 
 
ExclusionCriteria 
Details  History of surgery or any invasive procedure on the knee(s) with OA;
Undergone a physical therapy or muscle strengthening program for lower limb in the past 3 months;
Planned events, such as knee replacement or travel, which may interfere with the adherence of individuals during the trial period
History of acute myocardial infarction and/or stroke;
History of peripheral arterial disease or deep vein thrombosis;
History of cancer that has generated limitations or restrictions to physical exercise;
Decompensated systemic blood pressure without medical supervision
Changes in the dose or type of anti-inflammatory or analgesic drugs in the last 3 months
Morbid obese patients
Uncontrolled Diabetes
Neuropathy
Positive Homan’s sign
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1-RM knee extension and flexion for strength
WOMAC and The Lequesne Algofunctional Index for pain
The multidimensional fatigue inventory for fatigue
The Time Get Up and Go Test (TUG), 30-second Chair Stand Test (30-sCST), and 40m Fast Paced Walk Test (40mFPWT) for physical function and risk of fall
WHO BREF QOL for quality of life
 		 Pre interventional assessment and post interventional assessment will be taken of the outcome measures between the time period of 4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
None  N/A 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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   N/A 
Date of First Enrollment (India)   15/05/2023 
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="23"
Months="8"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
To investigate the effectiveness Low Intensity Blood Flow Restriction Training on physiological and pathological factors in patients with knee osteoarthritis.
This study is needed to investigate whether Blood Flow Restriction with Low Intensity Strength Training shows similar or varied results to High Intensity Strength Training in  strength, pain, fatigue, physical function and risk of fall and quality of life. 
 
Close