FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093593 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
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   Comparing the Benefit of Blood flow Blocking Training and Moderate-Intensity Exercises on Thigh Muscle Strength, Girth and Muscle Activation in Patients with knee pain 
Scientific Title of Study   Comparing the Effect of Blood flow Restriction Training and Moderate-Intensity Exercises on Quadriceps Muscle Strength, Hypertrophy and Motor Recruitment in patients with Osteoarthritis of knee: Two-arm parallel Experimental study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhumika Sureshkumar patel 
Designation  Assistant professor 
Affiliation  SPB Physiotherapy College 
Address  SPB Physiotherapy College OPD(Musculoskeletal and Sports Department Ground Floor) Ugat Bhesan Road Morabhagal Surat

Surat
GUJARAT
395005
India 
Phone  773836044  
Fax    
Email  bhumikapatelmpt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Salvi Shah 
Designation  Associate professor 
Affiliation  SPB Physiotherapy College 
Address  SPB Physiotherapy College OPD(Musculoskeletal and Sports Department Ground Floor) Ugat Bhesan Road Morabhagal Surat

Surat
GUJARAT
395005
India 
Phone  773836044  
Fax    
Email  shahsalup@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Salvi Shah 
Designation  Associate professor 
Affiliation  SPB Physiotherapy College 
Address  SPB Physiotherapy College OPD(Musculoskeletal and Sports Department Ground Floor) Ugat Bhesan Road Morabhagal Surat
SPB Physiotherapy College OPD(Musculoskeletal and Sports Department Ground Floor) Ugat Bhesan Road Morabhagal Surat
Surat
GUJARAT
395005
India 
Phone  94278000238  
Fax    
Email  shahsalup@yahoo.com  
 
Source of Monetary or Material Support  
SPB Physiotherapy College OPD(Musculoskeletal and Sports Department Ground Floor) Ugat Bhesan Road Morabhagal Surat Gujarat India 395005 
 
Primary Sponsor  
Name  BHUMIKA SURESHKUMAR PATEL 
Address  SPB Physiotherapy College OPD(Musculoskeletal and Sports Department Ground Floor) Ugat Bhesan Road Morabhagal Surat Gujarat India 395005 
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 Bhumika Sureshkumar Patel  SPB Physiotherapy College  SPB Physiotherapy College OPD(Musculoskeletal and Sports Department Ground Floor) Ugat Bhesan Road Morabhagal Surat 395005
Surat
GUJARAT 
773836044

bhumikapatelmpt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee SPB Physiotherapy College  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 
Comparator Agent  BFRT and Moderate Intensity Exercises  Blood Flow Restriction Training Combines Low Intensity Exercise with Blood Flow Occlusion Producing Results Similar to High Intensity Training. Moderate-Intensity Activity is usually made up of Exercises that get your Heart Rate up to 50% to 60% Higher than its Rate when youre at Rest. We Need to Compare BFRT Technique and Moderate Intensity Exercises to Determine which is more Effective in to Improve Muscle Girth Muscle Strength Muscle Activation Pain and Functionality in Patients with OA knee Total Duration of Each Group Treatment is 15 Mins 
Intervention  BFRT TRAINING along with Coventional Therapy  BFRT Technique: Patients will be asked to lie in a supine position while resting comfortably. A vascular Doppler probe will be placed over the tibial artery to capture its auscultatory pulse. For the determination of the cuff pressure (mm Hg) necessary for a complete blood flow restriction example pulse elimination pressure an air cuff will be attached to the patients thigh example inguinal fold region and then will be inflated up to the point in which the auscultatory pulse will be interrupted. Cuff pressure used during the training protocol will be determined as 70 percent of the necessary pressure for complete blood flow restriction in a resting condition. The average cuff pressure necessary for complete blood flow restriction will be (180 mm Hg to 238 mm Hg) used throughout the training protocol. Duration 15 mins per session, 5 sessions per week for 4 weeks Conventional Therapy-warmup, Traditional OA Exercises and modality  
Intervention  Moderate- intensity exercise Conventional Therapy  Moderate- intensity exercises will be performed two sets of 10 repetitions at 50 percent 1RM. The exercise load for each exercise during the training will be identified on the percentage of 1RM. The 7 to 10RM test will serve as an estimate for the 1RM in leg press and knee extension exercises, instead of directly performing a 1RM test that may result in discomfort or injury to the patients. The Bryzcki formula, 40 which is weight/ (1.0278 minus 0.0278 reps), will be used to estimate the 1RM. To account for physiological adaptation of resistance training. Conventional Therapy-warmup, Traditional OA Exercises and modality Duration 15 mins per session, 5 sessions per week for 4 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Unilateral OA and Bilateral OA but in case of Bilateral OA more symptomatic Knee were been taken Grade 1 and 2 on Lawrence and Kellegren Radiological Classification Ability to Walk Indoor and Outdoor without Walking Aids
NPRS Score Mild to Moderate
 
 
ExclusionCriteria 
Details  Moderate to High Intensity Exercise Training over the last year Cardiovascular Disease Unstable Hypertension Peripheral Vascular Disease Venous Thromboembolism Hemophilia Varicose Veins Any Inflammatory Arthritis Previous Injury to Knee or Hip Pregnancy Epilepsy Abnormal Sensation Patients had taken Intra Articular and Hyaluronic acid Injection less than 6 months Ligamentous Instability Soft Tissue Injury Family Medical History Cancer, Clotting History, Sickle Cell Disease Medications which Increases Blood Clotting Time

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A modified standard belt-stabilized Hand Held Dynamometer (HHD)- TO assess quadricep muscle strength
Electromyography- To assess Motor recruitment at Quadricep muscle.
Ultrasonograpy- to assess muscle Hypertrophy  
At Baseline, 4 Week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/09/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Mode

Comparing the Effect of Blood flow Restriction Training and Moderate-Intensity Exercises on Quadriceps Muscle Strength, Hypertrophy and Motor Recruitment in patients with Osteoarthritis of knee: Two-arm parallel Experimental study.

 Background: Knee osteoarthritis (OA) is a prevalent and debilitating condition affecting millions of people worldwide. It is characterized by cartilage degradation, joint pain, and limited mobility. Current management strategies often focus on pain relief and improving functional ability. Blood Flow Restriction Training (BFRT) has emerged as a potential therapeutic approach for OA management. BFRT involves restricting blood flow to the targeted muscle group while performing low-load resistance exercises, which can stimulate muscle growth and strength without the need for high-intensity exercise.

 Aim of Study: The primary aim of this study is to compare the effectiveness of BFRT with Moderate-Intensity Exercise in improving pain, quadriceps muscle strength, muscle hypertrophy, and functional ability in patients with grade I and II knee OA. By investigating the potential benefits of BFRT, this study seeks to provide insights into alternative management strategies for knee OA.

Significance of Study: This study is significant because it addresses a critical need for alternative management strategies for knee OA. If BFRT is found to be effective, it could provide a valuable option for patients who cannot tolerate high-intensity exercise, potentially improving their quality of life. The study’s findings could also contribute to the development of evidence-based guidelines for OA management, ultimately benefiting a large population of individuals affected by this condition

 

Procedure: This randomized controlled trial will recruit patients with grade I and II knee OA. Participants will be randomly assigned to either the BFRT group or the Moderate-Intensity Exercise group. The BFRT group will undergo low-load resistance training with blood flow restriction, while the Moderate-Intensity Exercise group will perform moderate-intensity exercises without blood flow restriction. The Moderate-Intensity Exercise group’s exercises will include:

 

1. Squats: 2 sets of 10 repetitions at 50 percent1-RM

2. Seated Leg Press: 2 sets of 10 repetitions at 50 percent 1-RM

3. Lunges: 2 sets of 10 repetitions at percent 1-RM

4. Static Quadriceps Exercises: 10 seconds hold, 10 repetitions

5. Straight Leg Raise Exercises: 10 repetitions

 

Outcome measures will include the Numerical Pain Rating Scale (NPRS) for pain assessment, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional ability, Hand Held Dynamometer (HHD) for quadriceps muscle strength, Electromyography (EMG) for muscle motor recruitment, and ultrasonography for muscle hypertrophy.

Statistical Analysis: Data will be analysed using SPSS Version 29.0. Descriptive analysis will be performed to summarize demographic variables and outcome measures. Based on the normality of distribution, either parametric or non-parametric tests will be used to analyze intergroup and intragroup differences. Within-group analysis will be done using paired t-tests or Wilcoxon signed rank tests, while between-group analysis will be conducted using independent t-tests or Mann Whitney U tests. The level of significance will be set at p less than or equal to 0.05.

Potential Impact: This study has the potential to contribute significantly to the management of knee OA. If BFRT is found to be effective, it could offer a valuable alternative for patients who cannot tolerate high-intensity exercise due to pain or other limitations. Ultimately, the findings of this study aim to improve the quality of life for individuals with knee OA by providing evidence-based guidance for optimal management strategies.

 
Close