Идёт набор NCT07601906

Effects of Progressive Restricted Blood Flow Exercises in Post Total Knee Arthroplasty

Без фазы С лечением Total Knee Arthroplasty Recovery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Blood Flow Restriction Exercises and Conventional Physical Therapy, Conventional Physical Therapy alone.
Кому может быть актуально: Состояния в реестре: Total Knee Arthroplasty Recovery. Базовые параметры: 50 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Пакистан
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Другое 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 streng
Другое 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 supervisi

Первичные конечные точки

Pain Intensity (Numeric Pain Rating Scale - NPRS) [Срок оценки: 6 weeks]
Range of Motion [Срок оценки: 6 weeks]
Swelling (Circumferential Measurement) [Срок оценки: 6 weeks]
Proprioception (Joint Position Sense Test - JPS) [Срок оценки: 6 weeks]
Kinesiophobia (Tampa Scale for Kinesiophobia - TSK-11) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

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