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临床试验/CTRI/2025/08/093593
CTRI/2025/08/093593尚未招募不适用

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.

BHUMIKA SURESHKUMAR PATEL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
A modified standard belt-stabilized Hand Held Dynamometer (HHD)- TO assess quadricep muscle strength

研究概览

简要总结

ModeComparing 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

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

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

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

  4. 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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

A modified standard belt-stabilized Hand Held Dynamometer (HHD)- TO assess quadricep muscle strength

时间窗: At Baseline, 4 Week

Electromyography- To assess Motor recruitment at Quadricep muscle.

时间窗: At Baseline, 4 Week

Ultrasonograpy- to assess muscle Hypertrophy

时间窗: At Baseline, 4 Week

次要结局

未报告次要终点

研究者

发起方
BHUMIKA SURESHKUMAR PATEL
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bhumika Sureshkumar patel

SPB Physiotherapy College

研究点 (1)

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