| 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
|
|
|
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
|
|
|
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 |
|
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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. |