Knee Arthroscopic SurgeryNCT07837154
Blood Flow Restriction Training in Knee Arthropathy
A study testing Blood flow restriction training with 60%-80% occlusion in people with Knee Arthroscopic Surgery and Arthrogenic Muscle Inhibition, run by Yuxiu Ji at 1 site in China.
Trial summary
Arthrogenic muscle inhibition (AMI) is the key neurophysiological cause of impeding quadriceps activation following anterior cruciate ligament reconstruction (ACLR). Blood flow restriction training (BFRT) may induce neuroplasticity whereas the neurophysiological responses remain uncertain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Arthroscopic Surgery, Arthrogenic Muscle Inhibition, Quadriceps Muscle Weakness
- What is being tested?
- Blood flow restriction training with 60%-80% occlusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Knee arthroscopy;
- Age 18-60 years;
- Ability to provide informed consent;
- Availability for follow-up assessments;
- Written informed consent.
Who cannot join
- Neurological disorders affecting lower extremity function;
- Vascular disease or coagulopathy;
- Contralateral knee pathology;
- Previous knee surgery;
- inability to comply with rehabilitation protocols;
- pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Chi Zhang, 86+13082566763, chizhang0123@swmu.edu.cn
About this study
Official title: Effects of Blood Flow Restriction Training on Lower Limb Muscle Strength and Atrophy in Patients With Knee Arthropathy: A Randomized Controlled Trial
Arthrogenic muscle inhibition (AMI) is the key neurophysiological cause of impeding quadriceps activation following anterior cruciate ligament reconstruction (ACLR). Blood flow restriction training (BFRT) may induce neuroplasticity whereas the neurophysiological responses remain uncertain. In this study, we aimed to explore the effects of constant pressure blood flow restriction training (CP-BFRT) on neurophysiological responses and physical function. Patients will receive the same standardized progressive physical rehabilitation for 2 weeks after the surgery and then start the BRFT or sham BRFT intervention for the following 12 weeks.
- Being tested
- Blood flow restriction training with 60%-80% occlusion, Standard postoperative knee rehabilitation with sham BFRT
- Keywords
- Arthrogenic muscle inhibition, Blood flow restriction training, Knee Arthroscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction training with 60%-80% occlusionOther
Also called KAATSU Training, Occlusion Training
A personalized constant-pressure system served as the active BFRT unit, with restrictive pressure set at 60%-80% of limb arterial occlusion pressure; it auto-inflates to maintain constant pressure and automatically monitors, assesses, and adjusts pressure during training.
Standard postoperative knee rehabilitation with sham BFRTOther
Standard postoperative rehabilitation protocol after knee arthroscopic surgery, without blood flow restriction training. The rehabilitation program includes range of motion exercises, muscle strength training, balance training and functional activity training, with the same schedule, frequency and duration as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction training group | Experimental | Progressive BFRT exercises with 60%-80% of arterial occlusion pressure. The BFRT protocol was individualized based on limb circumference and tolerance, with pressure settings determined using the limb occlusion pressure method. For lower extremity training, pressure was set at 60%-80% of arterial occlusion pressure (approximately 140-220 mmHg depending on individual limb characteristics). Receives: Other: Blood flow restriction training with 60%-80% occlusion |
| Control group | Sham comparator | Participants in CON group with sham BFRT completed 3 sets of 10 repetitions for each exercise with the sham unit set to 20 mmHg. The restriction pressure was based on prior work which shows that 20 mmHg is well below the threshold for either arterial or venous occlusion. Receives: Other: Standard postoperative knee rehabilitation with sham BFRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-reflex Hmax/Mmax Ratio
H-reflex is a validated neurophysiological indicator for evaluating spinal-level AMI after knee surgery which is applied to assess resting spinal reflex excitability of the knee extensor motor pool vastus medialis.
Unit of Measure: Ratio (dimensionless)
Measured: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes (4)
Knee Joint Position Sense (JPS) Accuracy
Knee proprioceptive acuity was evaluated using a calibrated isokinetic dynamometer. Participants were blindfolded to exclude visual interference and seated with the tested lower limb securely strapped to the dynamometer lever arm. The knee was passively positioned at three target flexion angles (30°, 60°, and 90°). After passive positioning and a 3-second holding phase, participants actively reproduced the perceived target angle independently. Absolute angular error was calculated as the absolute discrepancy between the preset target angle and the actively reproduced angle.
Unit of Measure: Degrees (°)
Measured: From enrollment to the end of treatment at 12 weeks.
Somatosensory Evoked Potential (SEP) P40 Latency
Cortical somatosensory afferent function was assessed via tibial nerve somatosensory evoked potentials (SEP). The P40 latency was defined as the time interval from stimulus onset to the occurrence of the P40 positive wave, representing the conduction efficiency and temporal characteristics of peripheral proprioceptive signals transmitting to the primary somatosensory cortex.
Unit of Measure: Milliseconds (ms)
Measured: From enrollment to the end of treatment at 12 weeks.
Somatosensory Evoked Potential (SEP) N45-P40 Peak-to-peak Amplitude
Central sensory integration plasticity was assessed via tibial nerve somatosensory evoked potentials (SEP). The N45-P40 peak-to-peak amplitude was calculated to evaluate cortical sensory gain and central inhibitory/excitatory balance.
Unit of Measure: Microvolts (μV)
Measured: From enrollment to the end of treatment at 12 weeks.
Quadriceps rapid torque development rate (RTD)
Quadriceps rapid torque development rate (RTD) was measured to quantify the efficiency of central motor unit recruitment and neuromuscular rapid-driving capability. Quadriceps RTD was calculated as the rate of torque increase within the early contraction phase, reflecting the recruitment efficacy of high-threshold type II muscle fibers and synchronous firing of motor units.
Unit of Measure: Nm/s
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroscopic SurgeryStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuxiu Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuxiu Ji, The Affiliated Hospital Of Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837154
- Sponsor's protocol ID
- KY2025082
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barzyk P, Fiedler C, Schlag M, Heitner A, Bender J, Paul J. Effect of blood flow restriction training in early postoperative rehabilitation after ACL reconstruction: a randomised controlled trial. Front Sports Act Living. 2026 Jan 14;7:1689257. doi: 10.3389/fspor.2025.1689257. eCollection 2025.
PubMed 41613017Erickson LN, Owen MK, Casadonte KR, Janatova T, Lucas K, Spencer K, Brightwell BD, Graham MC, White MS, Thomas NT, Latham CM, Jacobs CA, Conley CE, Thompson KL, Johnson DL, Hardy PA, Fry CS, Noehren B. The Efficacy of Blood Flow Restriction Training to Improve Quadriceps Muscle Function after Anterior Cruciate Ligament Reconstruction. Med Sci Sports Exerc. 2025 Feb 1;57(2):227-237. doi: 10.1249/MSS.0000000000003573. Epub 2024 Oct 1.
PubMed 39350350Wang H, Cao Y, Zhang J, Chen L, Liang D, Fang L, Qian Y, Huang G, Song L, Jia J. Effectiveness of Blood Flow Restriction Training in Neurological Rehabilitation: A Systematic Review and Meta-analysis. Sports Med Open. 2026 May 6;12(1):53. doi: 10.1186/s40798-026-01022-z.
PubMed 42090105Kakavas G, Sasse C, Krolikowska A, Wong S, Becker R, Prill R. Rehabilitation of Arthrogenic Muscle Inhibition in Patients with Knee Osteoarthritis and after Knee Arthroplasty. Curr Rev Musculoskelet Med. 2026 Jun 6;19(1):44. doi: 10.1007/s12178-026-10038-7.
PubMed 42249256
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Training on Lower Limb Muscle Strength and Atrophy in Patients With Knee Arthropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07837154
- Acronym / sponsor ID
- KY2025082
- Keywords
- Arthrogenic muscle inhibition, Blood flow restriction training, Knee Arthroscopic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Yuxiu JiUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 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.
Arthrogenic muscle inhibition (AMI) is the key neurophysiological cause of impeding quadriceps activation following anterior cruciate ligament reconstruction (ACLR). Blood flow restriction training (BFRT) may induce neuroplasticity whereas the neurophysiological responses remain uncertain. In this study, we aimed to explore the effects of constant pressure blood flow restriction training (CP-BFRT) on neurophysiological responses and physical function. Patients will receive the same standardized progressive physical rehabilitation for 2 weeks after the surgery and then start the BRFT or sham BRFT intervention for the following 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction training group | Experimental | Other: Blood flow restriction training with 60%-80% occlusionProgressive BFRT exercises with 60%-80% of arterial occlusion pressure. The BFRT protocol was individualized based on limb circumference and tolerance, with pressure settings determined using the limb occlusion pressure method. For lower extremity training, pressure was set at 60%-80% of arterial occlusion pressure (approximately 140-220 mmHg depending on individual limb characteristics). |
| Control group | Sham comparator | Other: Standard postoperative knee rehabilitation with sham BFRTParticipants in CON group with sham BFRT completed 3 sets of 10 repetitions for each exercise with the sham unit set to 20 mmHg. The restriction pressure was based on prior work which shows that 20 mmHg is well below the threshold for either arterial or venous occlusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Knee arthroscopy;
- Age 18-60 years;
- Ability to provide informed consent;
- Availability for follow-up assessments;
- Written informed consent.
Key exclusion criteria (6 listed)
- Neurological disorders affecting lower extremity function;
- Vascular disease or coagulopathy;
- Contralateral knee pathology;
- Previous knee surgery;
- inability to comply with rehabilitation protocols;
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 training with 60%-80% occlusionAlso: KAATSU Training, Occlusion TrainingA personalized constant-pressure system served as the active BFRT unit, with restrictive pressure set at 60%-80% of limb arterial occlusion pressure; it auto-inflates to maintain constant pressure and automatically monitors, assesses, and adjusts pressure during training. | Other | Blood flow restriction training group |
| Standard postoperative knee rehabilitation with sham BFRTStandard postoperative rehabilitation protocol after knee arthroscopic surgery, without blood flow restriction training. The rehabilitation program includes range of motion exercises, muscle strength training, balance training and functional activity training, with the same schedule, frequency and duration as the experimental group. | Other | Control group |
Primary outcome
H-reflex Hmax/Mmax Ratio
Time frame: From enrollment to the end of treatment at 12 weeks.
H-reflex is a validated neurophysiological indicator for evaluating spinal-level AMI after knee surgery which is applied to assess resting spinal reflex excitability of the knee extensor motor pool vastus medialis. Unit of Measure: Ratio (dimensionless)
4 secondary outcomes
Knee Joint Position Sense (JPS) Accuracy
Time frame: From enrollment to the end of treatment at 12 weeks.
Somatosensory Evoked Potential (SEP) P40 Latency
Time frame: From enrollment to the end of treatment at 12 weeks.
Somatosensory Evoked Potential (SEP) N45-P40 Peak-to-peak Amplitude
Time frame: From enrollment to the end of treatment at 12 weeks.
Quadriceps rapid torque development rate (RTD)
Time frame: From enrollment to the end of treatment at 12 weeks.
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 28 Oct 2026.
- Background: PubMed 41613017Barzyk P, Fiedler C, Schlag M, Heitner A, Bender J, Paul J. Effect of blood flow restriction training in early postoperative rehabilitation after ACL reconstruction: a randomised controlled trial. Front Sports Act Living. 2026 Jan 14;7:1689257. doi: 10.3389/fspor.2025.1689257. eCollection 2025.
- Background: PubMed 39350350Erickson LN, Owen MK, Casadonte KR, Janatova T, Lucas K, Spencer K, Brightwell BD, Graham MC, White MS, Thomas NT, Latham CM, Jacobs CA, Conley CE, Thompson KL, Johnson DL, Hardy PA, Fry CS, Noehren B. The Efficacy of Blood Flow Restriction Training to Improve Quadriceps Muscle Function after Anterior Cruciate Ligament Reconstruction. Med Sci Sports Exerc. 2025 Feb 1;57(2):227-237. doi: 10.1249/MSS.0000000000003573. Epub 2024 Oct 1.
- Background: PubMed 42090105Wang H, Cao Y, Zhang J, Chen L, Liang D, Fang L, Qian Y, Huang G, Song L, Jia J. Effectiveness of Blood Flow Restriction Training in Neurological Rehabilitation: A Systematic Review and Meta-analysis. Sports Med Open. 2026 May 6;12(1):53. doi: 10.1186/s40798-026-01022-z.
- Background: PubMed 42249256Kakavas G, Sasse C, Krolikowska A, Wong S, Becker R, Prill R. Rehabilitation of Arthrogenic Muscle Inhibition in Patients with Knee Osteoarthritis and after Knee Arthroplasty. Curr Rev Musculoskelet Med. 2026 Jun 6;19(1):44. doi: 10.1007/s12178-026-10038-7.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
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 training with 60%-80% occlusion in people with Knee Arthroscopic Surgery and Arthrogenic Muscle Inhibition, run by Yuxiu Ji at 1 site in China.
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 6 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 28 Oct 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 China. 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. Some participants in this study may receive a placebo. 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 Yuxiu Ji (86+0830-8950771, 1062111370@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H-reflex Hmax/Mmax Ratio (time frame: From enrollment to the end of treatment at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07837154, which also lists 4 linked publications.
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 28 Oct 2026.