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临床试验/NCT07601906
NCT07601906招募中不适用

Effects of Progressive Restricted Blood Flow Exercise on Pain, Range of Motion, Swelling, Proprioception and Kinesiophobia on Patients With Total Knee Arthoplasty

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年5月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1

研究概览

简要总结

Total knee arthroplasty (TKA) is a commonly performed procedure for advanced knee osteoarthritis. Despite successful surgery, many patients experience postoperative impairments including pain, reduced range of motion (ROM), swelling, impaired proprioception, and kinesiophobia, which may delay functional recovery.

Conventional physiotherapy is the standard rehabilitation approach following TKA; however, high-load strengthening exercises are often limited in the early postoperative phase due to pain and reduced tolerance.

Blood flow restriction (BFR) exercise is an emerging rehabilitation technique that enables low-load exercise to produce strength adaptations similar to high-intensity training. While evidence supports its effectiveness for improving muscle strength, its effects on other outcomes such as pain, swelling, proprioception, and kinesiophobia are not well established.

This randomized controlled trial will compare progressive BFR exercise combined with conventional physiotherapy versus conventional physiotherapy alone in patients following unilateral TKA. A total of 48 participants will be randomly allocated to two groups. The intervention will be delivered over 6 weeks with supervised sessions conducted three times per week.

Outcomes will include pain, knee ROM, swelling, proprioception, kinesiophobia, and functional performance. This study aims to determine whether BFR exercise provides additional benefits in postoperative rehabilitation following TKA.

详细描述

Total knee arthroplasty (TKA) is an effective surgical intervention for advanced knee osteoarthritis; however, postoperative impairments such as pain, limited range of motion (ROM), swelling, reduced muscle strength, impaired proprioception, and kinesiophobia are commonly reported and may delay recovery.

Conventional physiotherapy is routinely used following TKA and includes early mobilization, range of motion exercises, progressive strengthening, gait training, and functional activities. Although effective, the use of high-load resistance training in the early postoperative phase is often limited due to pain, joint stress, and patient intolerance.

Blood flow restriction (BFR) exercise is a rehabilitation technique that involves the application of external pressure to partially restrict blood flow during low-load exercise. This approach has been shown to improve muscle strength and hypertrophy while minimizing mechanical stress on the joint, making it suitable for early postoperative rehabilitation.

Current evidence supports the use of BFR for strength improvement; however, there is limited evidence regarding its effects on other clinically relevant outcomes such as pain, swelling, proprioception, and kinesiophobia following TKA. In addition, data from low- and middle-income settings are limited.

This study is a single-blinded, two-arm, parallel-group randomized controlled trial designed to evaluate the effects of progressive BFR exercise combined with conventional physiotherapy compared with conventional physiotherapy alone in patients following unilateral TKA.

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
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of age 50-65 years.
  • Primary unilateral TKA due to osteoarthritis.
  • Individuals with mild to moderate postoperative pain (NPRS score 4-7).
  • Minimum active knee flexion of 30° & an extension lag of no more than 15°.
  • Patients should be medically stable, cognitively able to follow instructions in Urdu or english, and willing to provide written informed consent

排除标准

  • History of deep vein thrombosis within the last six months.
  • Peripheral vascular disease and active infection.
  • Severe cardiovascular conditions
  • Neurological disorders affecting lower limb function

研究组 & 干预措施

Blood Flow Restriction Exercises and Conventional Physical therapy

Experimental

Participants in the experimental group will receive progressive blood flow restriction (BFR) exercise combined with conventional physical therapy following total knee arthroplasty. BFR will be applied using a pneumatic cuff placed proximally on the operated thigh at 20-40% limb occlusion pressure. Low-load therapeutic exercises will be performed under cuff inflation, including quadriceps sets, straight leg raises, heel slides, ankle pumps, sit-to-stand training, gait training, and functional strengthening exercises. Sessions will be conducted three times per week for 6 weeks under physiotherapist supervision in addition to standard postoperative rehabilitation.

干预措施: Blood Flow Restriction Exercises and Conventional Physical Therapy (Other)

Conventional Physical Therapy Alone

Active Comparator

Participants in the control group will receive conventional physical therapy following total knee arthroplasty. The rehabilitation program will include early mobilization, pain and swelling management, range of motion exercises, strengthening exercises, gait training, and functional activities such as ankle pumps, heel slides, quadriceps sets, straight leg raises, sit-to-stand training, and walking practice. Sessions will be conducted three times per week for 6 weeks under physiotherapist supervision along with a home exercise program.

干预措施: Conventional Physical Therapy alone (Other)

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Umber Nawaz

Assistant Professor

Lahore University of Biological and Applied Sciences

研究点 (1)

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