Effects of Progressive Restricted Blood Flow Exercises in Post Total Knee Arthroplasty (TKA PBFR)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Umber Nawaz
- 전화번호: +92 333 4888279
- 이메일: Umber.nawaz@ubas.edu.pk
연구 연락처 백업
- 이름: Shoaib Waqas
- 전화번호: +92 302 4552109
- 이메일: Shoaib.waqas@ubas.edu.pk
연구 장소
-
-
Punjab Province
-
Lahore, Punjab Province, 파키스탄
- Saleem Memorial Trust Hospital
-
연락하다:
- Ahmed Shoaib, Mbbs
- 전화번호: +923030007321
- 이메일: Ahmed.Shoaib@smth.pk
-
수석 연구원:
- Muhammad Noman Zafar, Dpt,MSPT
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Patients of age 50-65 years, Undergoing 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
Exclusion Criteria:
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
|
활성 비교기: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Intensity (Numeric Pain Rating Scale - NPRS)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 의자: Shoaib Waqas, Lahore University of Biological and Applied Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UBAS/ERB/26/043020
- U1111-1339-8252 (레지스트리 식별자: WHO Universal Trial Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .