Total Knee Arthroplasty RecoveryTKA PBFRNCT07601906
Effects of Progressive Restricted Blood Flow Exercises in Post Total Knee Arthroplasty
A study testing Blood Flow Restriction Exercises and Conventional Physical Therapy and Conventional Physical Therapy alone in people with Total Knee Arthroplasty Recovery, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Total Knee Arthroplasty Recovery
- What is being tested?
- Blood Flow Restriction Exercises and Conventional Physical Therapy and Conventional Physical Therapy alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 25 May 2026to 20 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Saleem Memorial Trust Hospital
Lahore, Punjab Province
Ahmed Shoaib, Mbbs,FRCS, +923030007321, Ahmed.Shoaib@smth.pk
Muhammad Noman Zafar, Dpt,MSPT
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Total Knee Arthroplasty Recovery
- Being tested
- Blood Flow Restriction Exercises and Conventional Physical Therapy, Conventional Physical Therapy alone
- Keywords
- Blood Flow Restriction Exercises, Post-Total Knee Arthroplasty, Conventional Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Exercises and Conventional Physical TherapyOther
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.
Conventional Physical Therapy aloneOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physical Therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start25 May 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty RecoveryStudies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umber Nawaz, Lahore University of Biological and Applied Sciences
- Investigators
- Shoaib Waqas, Study chair, Lahore University of Biological and Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601906
- Sponsor's protocol ID
- UBAS/ERB/26/043020
- Other IDs
- U1111-1339-8252
- Acronym
- TKA PBFR
- Status last verified
- Apr 2026
- First submitted
- 15 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Restricted Blood Flow Exercise on Pain, Range of Motion, Swelling, Proprioception and Kinesiophobia on Patients With Total Knee Arthoplasty
- ClinicalTrials.gov ID
- NCT07601906
- Acronym / sponsor ID
- TKA PBFR / UBAS/ERB/26/043020
- Conditions
- Total Knee Arthroplasty Recovery
- Keywords
- Blood Flow Restriction Exercises, Post-Total Knee Arthroplasty, Conventional Physical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Exercises and Conventional Physical therapy | Experimental | Other: Blood Flow Restriction Exercises and Conventional Physical TherapyParticipants 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. |
| Conventional Physical Therapy Alone | Active comparator | Other: Conventional Physical Therapy aloneParticipants 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction Exercises and Conventional Physical TherapyParticipants 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. | Other | Blood Flow Restriction Exercises and Conventional Physical therapy |
| Conventional Physical Therapy aloneParticipants 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. | Other | Conventional Physical Therapy Alone |
Primary outcome
Pain Intensity (Numeric Pain Rating Scale - NPRS)
Time frame: 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.
Range of Motion
Time frame: 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.
Swelling (Circumferential Measurement)
Time frame: 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.
Proprioception (Joint Position Sense Test - JPS)
Time frame: 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.
Kinesiophobia (Tampa Scale for Kinesiophobia - TSK-11)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shoaib Waqas study chair
Lahore University of Biological and Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Exercises and Conventional Physical Therapy and Conventional Physical Therapy alone in people with Total Knee Arthroplasty Recovery, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umber Nawaz (+92 333 4888279, Umber.nawaz@ubas.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numeric Pain Rating Scale - NPRS) (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.