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

NCT07601906 | Not Yet Recruiting

• 2 other identifiers: UBAS/ERB/26/043020U1111-1339-8252
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty Recovery

Keywords

Blood Flow Restriction Exercises; Post-Total Knee Arthroplasty; Conventional Physical Therapy

Outcome Measures

Primary Outcomes (5)

• Pain Intensity (Numeric Pain Rating Scale - NPRS)

  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

  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)

  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)

  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)

  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

Study Arms (2)

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.

Other: Blood Flow Restriction Exercises and Conventional Physical Therapy

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.

Other: Conventional Physical Therapy alone

Interventions

Blood Flow Restriction Exercises and Conventional Physical Therapy OTHER

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.

Blood Flow Restriction Exercises and Conventional Physical therapy

Conventional Physical Therapy alone OTHER

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.

Conventional Physical Therapy Alone

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

Saleem Memorial Trust Hospital

Lahore, Punjab Province, Pakistan

Location

Study Officials

• Shoaib Waqas

  Lahore University of Biological and Applied Sciences

  STUDY CHAIR

Central Study Contacts

Umber Nawaz

CONTACT

+92 333 4888279; Umber.nawaz@ubas.edu.pk

Shoaib Waqas

CONTACT

+92 302 4552109; Shoaib.waqas@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)