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Clinical Trials/CTRI/2024/12/077895
CTRI/2024/12/077895Not yet recruitingPhase 3

Augmenting the impact of blood flow restriction training for management of knee osteoarthritis on pain, muscle strength and overall quality of life

Hijab Chaudhry1 site in 1 country74 target enrollmentStarted: December 20, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
74
Locations
1
Primary Endpoint
Pain, Physical Function, Muscle Strength and Quality of Life

Study Overview

Brief Summary

Knee osteoarthritis (OA) is more prevalent in women aged 40–50 and men above 55. The management of knee OA poses significant challenges, as symptoms progressively affect physical, physiological, and social aspects of health, leading to pain and disability. Although international studies highlight the efficacy of blood flow restriction (BFR) training in addressing these issues, research on its application in the Indian context remains scarce.

This study aims to evaluate the effectiveness and safety of BFR training in knee OA patients in India, contributing to evidence-based, culturally relevant rehabilitation practices.

Aim:

1. To determine the impact of blood flow restriction training for treating knee osteoarthritis on pain and physical function.

2. To determine the impact of blood flow restriction training for treating knee osteoarthritis on muscle strength.

3. To determine the impact of blood flow restriction training for treating knee osteoarthritis on quality of life.

Objectives:

1.Assess the impact of BFR training on pain and physical function in individuals with knee OA

  1. Evaluate the effect of BFR training on muscle strength in knee OA patients.

3.Analyze the influence of BFR training on the quality of life (QOL) in individuals with knee OA

Hypothesis:

Null Hypothesis –

Ø   1:No significant improvement in pain and physical function was observed with the application of BFR training in individuals with knee osteoarthritis.

Ø   2:No significant improvement was observed in muscle strength with the application of BFR training in individuals with knee osteoarthritis.

Ø   3: No significant improvement in quality of life was observed with the application of BFR training in individuals with knee osteoarthritis.

Alternate Hypothesis –

Ø 1:Significant improvement on pain and physical function with the application of BFR training in individuals with knee osteoarthritis.

Ø 2:Significant improvement on muscle strength with the application of BFR training in individuals with knee osteoarthritis.

Ø 3:Significant improvement was observed in quality of life with the application of BFR training in individuals with knee osteoarthritis.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
40.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Both male and female 2 Age group between 40 years to 60 years 3 Participants having knee osteoarthritis confirmed by Xray and ACR criteria (Grade 2 and Grade 3) 4 Willing to participate in the study by signing informed consent.

Exclusion Criteria

  • 1 Age below 40 years and above 60 years 2 Recent surgery, fracture, injury 3 Any medical condition which can affect the health status of the participants 4 History of DVT, diabetes, hypertension, varicose veins, and perivascular disease.

Outcomes

Primary Outcomes

Pain, Physical Function, Muscle Strength and Quality of Life

Time Frame: Baseline assessment - before intervention | Follow-up assessment- After 3rd week | Final assessment - After 6th week

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hijab Chaudhry
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Hijab Chaudhry

Department of Physiotherapy, Amity Institute of Health Allied Sciences

Study Sites (1)

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