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CTRI Number  CTRI/2024/05/066785 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of blood flow restriction training (BFRT) versus conventional endurance training on pain, ability to walk for long durations and function in patients with osteoarthritis of the knee - A randomized control trial 
Scientific Title of Study   Effects of blood flow restriction training (BFRT) versus conventional endurance training on pain, walking endurance and function in patients with knee osteoarthritis- A randomized control trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arti Premnarayan Vaidya  
Designation  post gradute student 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar, Pune – 411 005

Pune
MAHARASHTRA
411005
India 
Phone  7218208163  
Fax    
Email  vaidyaarati5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sona Kolke 
Designation  Professor and HOD Musculoskeletal Department 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, Department of musculoskeletal physiotherapy, 11/12 Thube Park, Shivajinagar, Pune – 411 005

Pune
MAHARASHTRA
411005
India 
Phone  9371004121  
Fax    
Email  sona.sarma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sona Kolke 
Designation  Professor and HOD Musculoskeletal Department 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, Department of musculoskeletal physiotherapy, 11/12 Thube Park, Shivajinagar, Pune – 411 005

Pune
MAHARASHTRA
411005
India 
Phone  9371004121  
Fax    
Email  sona.sarma@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar, Pune – 411 005, India 
 
Primary Sponsor  
Name  Arti Premnarayan Vaidya 
Address  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar, Pune – 411 005 
Type of Sponsor  Other [self] 
 
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 Arti Premnarayan Vaidya  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of physiotherapy 11/12 Thube Park Shivaji Nagar Pune 411005
Pune
MAHARASHTRA 
7218208163

vaidyaarati5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blood flow restriction training (BFRT)  The experimental group will receive walking endurance with blood flow restriction training, session will be for 15- 20 min with 40-50% heart rate reserve, 3 sessions per week (on alternate days) for a period of 6 weeks. 
Comparator Agent  conventional endurance training  The control group will receive conventional walking endurance training and will be for 30- 45 min with 40-50% heart rate reserve, 3 sessions per week (on alternate days) for a period of 6 weeks.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients diagnosed with knee OA,
Patients with Kellegren-Lawrence grade 2- 3 knee osteoarthritis,
Either gender with age group of 45- 65 years,
Knee pain on visual analog scale greater than 3 or less than or equal to 7 
 
ExclusionCriteria 
Details  Recent injury, uncontrolled hypertension, uncontrolled diabetes mellitus, clotting disorders, varicose veins, Metabolic, and endocrine disorders, which precluded exercise participation,
Intra articular infiltration with hyaluronic acid and corticosteroids infiltration over the last 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale, 6 min walk test, SF36 ( Short Form), WOMAC scale CRD version  At baseline (0 week)
Post intervention (after 6 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Seven Day Physical Activity Recall (7 day PAR), AIMS2 (Arthritis Impact Measurement Scale), Timed up and go test, 30 sec sit to stand test
 
At baseline (0 week)
Post intervention (after 6 weeks) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/05/2024 
Date of Study Completion (India) 15/04/2025 
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)   Not Applicable 
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 - NO
Brief Summary  

Osteoarthritis is a heterogeneous chronic progressive disease traditionally characterized by cartilage degeneration, joint space narrowing, and osteophyte formation. Common clinical symptoms include gradual onset knee pain worsened with activity, knee stiffness, and swelling. Weakness of the quadriceps and muscles of the feet, along with proprioceptive loss, leads to changes in balance and gait, limiting the ability to climb stairs, rise from a chair, and walk, ultimately resulting in dependency in daily living activities. Inactivity leads to decreased aerobic capacity, endurance, and mobility, ultimately resulting in a reduction in quality of life. Blood flow restriction training (BFRT) provides a method to facilitate aerobic capacity with minimum duration. The controlled compression and restricted blood flow may create an environment where individuals can engage in exercise with less pain, which may eventually result in improved walking endurance. However, there has been limited exploration of the BFRT in improving the endurance in patients with knee OA. Engaging in tolerable exercise programs is beneficial for these patients, as it helps reduce fatigue, anxiety, and recover their self-esteem, motivation, and well-being. With paucity of literature on blood flow restriction training on knee OA, there is a need to explore its efficacy. Thus, the current study aims to compare the effects of blood flow restriction training with conventional endurance training on pain, walking endurance, and function in patients with knee OA.

Primary Hypothesis: There will be equal effects of blood flow restriction training and conventional endurance training on pain, walking endurance, and function in patients with knee osteoarthritis

Alternate Hypothesis: Blood flow restriction training will have better effects on pain, walking endurance, and function in patients with knee osteoarthritis

 

 

 
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