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Effects of Progressive Restricted Blood Flow Exercises in Post Total Knee Arthroplasty (TKA PBFR)

2026年6月5日 更新者：Umber Nawaz、Lahore University of Biological and Applied Sciences

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

Participants will be recruited during the early postoperative phase after medical clearance. Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group (BFR plus conventional physiotherapy) or the control group (conventional physiotherapy alone).

The intervention period will be 6 weeks, with supervised sessions conducted three times per week. The BFR protocol will involve application of a pneumatic cuff to the proximal thigh with individualized pressure based on limb occlusion pressure. Exercise intensity and progression will be adjusted over time, starting with low-load exercises and advancing to functional strengthening and mobility tasks as tolerated.

Both groups will receive standard postoperative care, including pain management, swelling control, and functional rehabilitation. The only difference between groups will be the addition of BFR exercise in the experimental group.

Outcome measures will assess pain, knee ROM, swelling, proprioception, kinesiophobia, and functional outcomes. Assessments will be conducted at baseline and after completion of the intervention.

The results of this study will provide evidence regarding the effectiveness of progressive BFR exercise as an adjunct to conventional physiotherapy in improving postoperative recovery following TKA. If effective, this approach may support the use of low-load rehabilitation strategies to enhance functional outcomes and patient recovery.

研究类型

介入性

注册 (估计的)

48

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 巴基斯坦
    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦
        • 招聘中
        • Saleem Memorial Trust Hospital
        • 首席研究员：
          • Muhammad Noman Zafar, Dpt,MSPT
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Blood Flow Restriction Exercises and Conventional Physical therapy
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.
其他：Blood Flow Restriction Exercises and Conventional Physical Therapy
Participants in the experimental group will receive progressive blood flow restriction (BFR) exercise combined with conventional physiotherapy 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.
有源比较器：Conventional Physical Therapy Alone
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.
其他：Conventional Physical Therapy alone
Participants in the control group will receive conventional physiotherapy 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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pain Intensity (Numeric Pain Rating Scale - NPRS)
大体时间：6 weeks
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their level of pain at rest or during movement. The NPRS is a reliable and valid tool commonly used in musculoskeletal and postoperative populations. A decrease in NPRS score will indicate improvement in pain levels following the intervention.
6 weeks
Range of Motion
大体时间：6 weeks
Knee range of motion will be measured using a standard universal goniometer. Active knee flexion and extension will be assessed in a standardized position by a trained assessor. Goniometric measurement is widely used and has good reliability in clinical settings. An increase in range of motion values will indicate improvement in joint mobility and functional recovery following total knee arthroplasty.
6 weeks
Swelling (Circumferential Measurement)
大体时间：6 weeks
Knee swelling will be assessed using circumferential measurement with a non-elastic measuring tape at predefined anatomical landmarks around the knee joint. This method is commonly used in clinical practice and demonstrates good intra-rater reliability. A reduction in limb circumference will indicate a decrease in postoperative swelling.
6 weeks
Proprioception (Joint Position Sense Test - JPS)
大体时间：6 weeks
Proprioception will be evaluated using the Joint Position Sense (JPS) test. The assessor will passively position the participant's knee at a target angle, and the participant will then attempt to actively reproduce the same position without visual feedback. The absolute angular error between the target and reproduced position will be recorded. Lower error values indicate improved proprioceptive accuracy and neuromuscular control.
6 weeks
Kinesiophobia (Tampa Scale for Kinesiophobia - TSK-11)
大体时间：6 weeks
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK-11), a validated questionnaire that measures fear of movement or reinjury. The scale consists of 11 items scored on a Likert scale, with total scores ranging from 11 to 44. Higher scores indicate greater fear of movement. A reduction in score will reflect improvement in psychological readiness and confidence in movement.
6 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Lahore University of Biological and Applied Sciences

调查人员

  • 学习椅：Shoaib Waqas、Lahore University of Biological and Applied Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月25日

初级完成 (估计的)

2026年10月31日

研究完成 (估计的)

2026年11月20日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • UBAS/ERB/26/043020
  • U1111-1339-8252 (注册表标识符：WHO Universal Trial Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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