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临床试验/NCT07722975
NCT07722975已完成不适用

Effects of Intermittent Versus Continuous Blood Flow Restriction Training on Pain, Functional Ability, Muscle Strength and Exercise Perception Among Female Patients With Grade II Knee Osteoarthritis

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Manual Muscle Testing (MMT)

研究概览

简要总结

This study holds significant clinical, academic, and practical importance in the field of musculoskeletal rehabilitation. Clinically, it addresses a critical need to identify an effective and tolerable strengthening strategy for females with early-stage knee osteoarthritis. By directly comparing intermittent and continuous BFR protocols, the findings will provide physiotherapists with evidence-based guidance for optimizing exercise prescription while minimizing discomfort and improving adherence.Academically, this research contributes to the limited body of literature comparing different BFR application strategies in knee osteoarthritis. The inclusion of exercise perception outcomes adds valuable insight into patient-centered rehabilitation, which is often underrepresented in clinical trials.From a practical and societal perspective, identifying a more tolerable BFR approach may enhance long-term exercise participation, delay disease progression, and reduce healthcare burden associated with knee osteoarthritis. The findings may also support the integration of low-load BFR training into rehabilitation programs in resource-limited clinical settings.

详细描述

Knee osteoarthritis (KOA) is a chronic, progressive musculoskeletal disorder characterized by joint degeneration, pain, muscle weakness, and functional limitations, with a higher prevalence among middle-aged women. Quadriceps muscle weakness is a key clinical feature associated with reduced functional capacity and progression of the disease. Although high-load resistance training is considered effective for improving muscle strength, its application is often limited in symptomatic individuals due to increased joint loading and pain, thereby affecting adherence to rehabilitation programs.In recent years, low-load resistance training combined with Blood Flow Restriction (BFR) has gained attention as a viable alternative for enhancing muscle strength while minimizing mechanical stress on the joint. BFR training can be applied using continuous or intermittent protocols. Continuous BFR maintains cuff pressure throughout both exercise and rest periods, whereas intermittent BFR involves periodic deflation during rest intervals. These variations may influence physiological responses, fatigue levels, perceived exertion, and overall exercise tolerance, which are critical factors in clinical rehabilitation.This randomized controlled trial is designed to compare the effects of intermittent and continuous BFR training on pain, functional ability, muscle strength, and exercise perception in females with Grade II knee osteoarthritis. A total of 84 participants will be randomly allocated into two intervention groups and will undergo structured low-load resistance training in conjunction with standard physiotherapy care over a period of 8-12 weeks.Outcome measures will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks, including pain intensity (Numeric Pain Rating Scale), functional status (WOMAC Index), quadriceps muscle strength, and perceived exertion (Modified Borg Scale). The findings of this study are expected to provide evidence-based insights into the comparative effectiveness and tolerability of BFR application methods, thereby supporting optimized rehabilitation strategies and improving patient-centered outcomes in knee osteoarthritis management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

outcome assessor will be blind about participants allocation; this will ensure that their evaluations are objective and not influenced by knowledge of which treatment group participants belong to. Participants in both groups will be masked to the treatment of the other group by scheduling their sessions at different times

入排标准

年龄范围
40 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 40-49 years.
  • Diagnosed with Grade II knee osteoarthritis (radiographically confirmed).
  • Moderate to severe pain (NPRS 4-7).
  • Ability to participate in exercise programs.

排除标准

  • Severe cardiovascular disease.
  • Uncontrolled hypertension.
  • Recent knee surgery or intra-articular injection.
  • Active cancer or metastatic disease

结局指标

主要结局

Manual Muscle Testing (MMT)

时间窗: baseline, 6 weeks (post intervention), 12 weeks (follow up)

Quadriceps strength will be assessed using standardized isometric testing procedure. It grades muscle strength on a 0-5 scale based on the ability to move a joint against gravity and external resistance. A grade of 0 indicates no visible or palpable muscle contraction, while 1 (Trace) represents a slight contraction without actual movement. Grade 2 (Poor) describes the ability to move the joint through its full range only when gravity is eliminated, whereas Grade 3 (Fair) allows movement through the full range against gravity but without resistance. Grade 4 (Good) indicates movement against moderate resistance, and Grade 5 (Normal) reflects full range of motion against maximal resistance, representing normal muscle strength

Numeric Pain Rating Scale (NPRS)

时间窗: baseline, 6 weeks (post intervention), 12 weeks( followup)

The NPRS is a10-point scale (0-10) used to quantify pain intensity. Pain severity will be interpreted as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).

Modified Borg Scale

时间窗: baseline, 6 weeks( post intervention), 12 weeks (follow up)

It is used to assess ratings of exercise-related perceived exertion. The scale ranges from (0 to 10), where 0 means no breathlessness at all and 10 means maximium breathlessness. According to this, 0-2 for Minimal exertion, 3-4 for Moderate (often target for rehab), 5-6 for Hard and 7-10 is for Very hard to maximal

次要结局

未报告次要终点

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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