Knee OsteoarthritisNCT06111690

Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

A study testing Blood Flow Restriction Training (BFRT) in people with Knee Osteoarthritis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim is to demonstrate that preoperative exercises (pre-habilitation) using blood-flow restriction training (BFRT) is safe, well tolerated, improves muscle function, decreases functional limitation, and increases physical activity in older adults awaiting total knee replacement (TKR). Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Blood Flow Restriction Training (BFRT)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 23 Sep 2022to 2 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants are awaiting primary unilateral TKR due to diagnosis of end-stage KOA. Potential individuals must have at least 8 weeks waiting time in between study baseline assessment and surgery. This 8-week timeframe will allow for completion of baseline (T0) and follow-up assessments (T1: immediately after 6-week prehabilitation program);
are older than 60 years;
speak fluent English to reliably complete the study questionnaires and understand study instructions.

Who cannot join

have a history of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis;
have absolute contraindications to exercise, as established by the American College of Sports Medicine (uncontrolled arrhythmias, third degree heart block, recent EKG changes, unstable angina, acute myocardial infarction, and acute congestive heart failure);
report of 2 or more falls within the past year;
cannot walk a distance of 100 feet (30.5 meters) without an assistive device or need of a rest period;
have bilateral TKR or undergoing TKR revision or other total joint replacement in the lower extremities; or
have severe visual or hearing impairment. In addition to the affects that these impairments have on safety during participation in the intervention, they may also interfere with data collection (questionnaires and telephone checks);

Show all 19Show fewer

have a lower extremity amputation;
are unable to comfortably bear weight on the affected knee;
have a BMI above 40.
history of muscular disease (e.g., muscular dystrophy) or neurological disorder that may affect lower extremity function (e.g., cerebrovascular accident, neuropathy, Parkinson's disease, multiple sclerosis);
had additional surgery to the lower extremities within the past 12 months.
a Folstein Mini-Mental State Examination score of <24.
have acute or terminal illness;
are planning to have another TKR (primary on contralateral, or revision on same knee) within 4 months;
are planning to relocate to another city within 4 months.
Subjects with Sickle cell disease
lymphedema or vascular access restrictions
Subjects who have any on-going medical emergency
An ankle-brachial index outside of the expected range 0.9 and 1.3

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Health San Antonio- Dept. of Physical Therapy
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Feasibility of Prehabilitation Blood-flow Restriction Training in Individuals Awaiting Total Knee Replacement.

Read the detailed description

Twenty individuals ≥60 years old awaiting TKR due to diagnosis of end-stage knee osteoarthritis who meet the inclusion/exclusion criteria will be invited to participate in a 6 weeks of low-intensity BFRT prehabilitation. We will assess muscle functional (i.e., cross-sectional area and intramuscular fatty content) using computerized tomography, quadriceps muscle strength using an isokinetic dynamometer, a battery of performance-based physical function, self-reported physical function and quality of life, and biomarkers of inflammation using blood serum. Feasibility assessment will be done by looking at safety (i.e., adverse events), compliance, and attrition rate.

Conditions: Knee Osteoarthritis
Being tested: Blood Flow Restriction Training (BFRT)
Keywords: Blood flow restriction training (BFRT), Preoperative exercise, Muscle function, Physical activity
Medical subject headings: Osteoarthritis, Knee, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood Flow Restriction Training (BFRT)Procedure or surgery
Also called BFRT
Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session

Study groups in NCT06111690
Study group	Role	What they receive
Preoperative Exercises	Experimental	Intervention is blood flow restriction training (BFRT) Receives: Procedure: Blood Flow Restriction Training (BFRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Quadricep Muscle Strength
Quadricep Muscle Strength will be measured using an isokinetic dynamometer. Quadriceps femoris maximum voluntary isometric contraction (MVIC) as torque output (Nm) will be measured. Subjects will be seated in the dynamometer's chair with their knee at 60 degrees of flexion.
Measured: Baseline, 8 weeks and 16 weeks
Leg Muscles Percentage of Fat Mass
Leg muscles % fat mass will be measured using a DXA scan.
Measured: Baseline, 8 weeks and 16 weeks
Leg Muscles Lean Mass in Kilograms
Leg muscles lean mass in kilograms will be measured using a DXA scan.
Measured: Baseline, 8 weeks and 16 weeks

Secondary outcomes (9)

Self-selected Gait Speed
Subject will walk a 4-meter walkway at a self-selected pace. Time to complete task will be recorded.
Measured: Baseline, 8 weeks and 16 weeks
Timed up and go Test
Subject will get up from a chair, walk 3 meters, turn around and walk back to and sit on the chair. Time to complete task will be recorded.
Measured: Baseline, 8 weeks and 16 weeks
30-second Chair Stand Test
Subject will perform sit-to-stand from a standard chair for 30 seconds. Number of times of completed sit-to-stand in 30 seconds will be recorded.
Measured: Baseline, 8 weeks and 16 weeks
Stair Climb Test
Subject will climb up and down a flight of stairs (11 steps). Time to complete task will be recorded.
Measured: Baseline, 8 weeks and 16 weeks
6-minute Walk Test
Subjects will cover as much as they can while walking on a flat, unobstructed path for 6 minutes.
Measured: Baseline, 8 weeks and 16 weeks
Patient-Reported Physical Outcomes Measurement Information System (PROMIS
Patient-Reported Physical Outcome will be assessed using PROMIS® (Patient-Reported Outcomes Measurement Information System), which is used to evaluate and monitor physical, mental, and social health in persons with several conditions. This is a 20 item survey with each item scored from 1-5. Total possible scores range from 5-100 with a higher score indicating better physical function.
Measured: Baseline, 8 weeks and 16 weeks
Health Related Quality of Life (RAND-36)
The RAND-36 Questionnaire is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. All questions are scored on a scale from 0 (worst) to 100 (best), with 100 representing the highest level of functioning possible. Aggregate scores are calculated between 0-100 with higher scores representing better quality of life.
Measured: Baseline, 8 weeks and 16 weeks
Real-time Physical Activity
An activity monitor will be worn for 7 days and physical activity (i.e., daily number of steps) will be tracked.
Measured: Baseline, 8 weeks and 16 weeks
Inflammatory Biomarkers
Change in 'MILLIPLEX® MAP Human High Sensitivity T Cell Magnetic Bead Panel' to assess a panel of 8 inflammatory biomarkers: Interleukin (IL)-1β, IL-2, IL-5, IL-6, IL-10, IL-12p70, IL-13 and Interferon-γ.
Measured: Baseline, 8 weeks and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 20222 Dec 2024

First posted1 Nov 2023
Study start23 Sep 2022
Primary completion2 Oct 2024
Study completion2 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center at San AntonioThe 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: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single group pre-post design study
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06111690
Sponsor's protocol ID: HSC20210590H
Other IDs: 5P30AG044271
Status last verified: Mar 2026
First submitted: 26 Oct 2023
Last updated: 24 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified data will be shared with other researchers at UT Health San Antonio, with the NIH and on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Prehabilitation Blood-flow Restriction Training in Individuals Awaiting Total Knee Replacement.
ClinicalTrials.gov ID: NCT06111690
Acronym / sponsor ID: HSC20210590H
Conditions: Knee Osteoarthritis
Keywords: Blood flow restriction training (BFRT), Preoperative exercise, Muscle function, Physical activity
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 23 Sep 2022 (actual)
Primary completion: 2 Oct 2024 (actual)
Study completion: 2 Dec 2024 (actual)
First posted: 1 Nov 2023 (actual)
Results: Posted 24 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single group pre-post design study

Arm	Type	Receives
Preoperative Exercises	Experimental	Procedure: Blood Flow Restriction Training (BFRT)Intervention is blood flow restriction training (BFRT)

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Participants are awaiting primary unilateral TKR due to diagnosis of end-stage KOA. Potential individuals must have at least 8 weeks waiting time in between study baseline assessment and surgery. This 8-week timeframe will allow for completion of baseline (T0) and follow-up assessments (T1: immediately after 6-week prehabilitation program);
are older than 60 years;
speak fluent English to reliably complete the study questionnaires and understand study instructions.

Key exclusion criteria (19 listed)

have a history of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis;
have absolute contraindications to exercise, as established by the American College of Sports Medicine (uncontrolled arrhythmias, third degree heart block, recent EKG changes, unstable angina, acute myocardial infarction, and acute congestive heart failure);
report of 2 or more falls within the past year;
cannot walk a distance of 100 feet (30.5 meters) without an assistive device or need of a rest period;
have bilateral TKR or undergoing TKR revision or other total joint replacement in the lower extremities; or

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 (BFRT)Also: BFRTParticipants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session	Procedure or surgery	Preoperative Exercises

Primary outcome

Quadricep Muscle Strength
Time frame: Baseline, 8 weeks and 16 weeks
Quadricep Muscle Strength will be measured using an isokinetic dynamometer. Quadriceps femoris maximum voluntary isometric contraction (MVIC) as torque output (Nm) will be measured. Subjects will be seated in the dynamometer's chair with their knee at 60 degrees of flexion.
Leg Muscles Percentage of Fat Mass
Time frame: Baseline, 8 weeks and 16 weeks
Leg muscles % fat mass will be measured using a DXA scan.
Leg Muscles Lean Mass in Kilograms
Time frame: Baseline, 8 weeks and 16 weeks
Leg muscles lean mass in kilograms will be measured using a DXA scan.

9 secondary outcomes

Self-selected Gait Speed
Time frame: Baseline, 8 weeks and 16 weeks
Timed up and go Test
Time frame: Baseline, 8 weeks and 16 weeks
30-second Chair Stand Test
Time frame: Baseline, 8 weeks and 16 weeks
Stair Climb Test
Time frame: Baseline, 8 weeks and 16 weeks
6-minute Walk Test
Time frame: Baseline, 8 weeks and 16 weeks
Patient-Reported Physical Outcomes Measurement Information System (PROMIS
Time frame: Baseline, 8 weeks and 16 weeks
Health Related Quality of Life (RAND-36)
Time frame: Baseline, 8 weeks and 16 weeks
Real-time Physical Activity
Time frame: Baseline, 8 weeks and 16 weeks
Inflammatory Biomarkers
Time frame: Baseline, 8 weeks and 16 weeks

Results and safety

Results posted to the registry on 24 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Preoperative Exercises	16	14

Primary outcome: Quadricep Muscle Strength

Time frame: Baseline, 8 weeks and 16 weeks. Mean (Standard Deviation). Unit: torque newton-meter

Measure	Preoperative Exercises n = 14
Baseline assessment (non-surgical side)	86.15 (28.39)
Baseline assessment (surgical side)	76.55 (37.23)
8-week assessment (non-surgical side)	91.03 (29.13)
8-week assessment (surgical side)	80.32 (36.94)
16-week assessment (non-surgical side)	85.24 (20.86)
16-week assessment (surgical side)	55.49 (17.57)

Primary outcome: Leg Muscles Percentage of Fat Mass

Time frame: Baseline, 8 weeks and 16 weeks. Mean (Standard Deviation). Unit: Percentage

Measure	Preoperative Exercises n = 7
Baseline %Fat (non-surgical side)	47.88 (3.42)
Baseline %Fat (surgical side)	47.28 (3.31)
8-week %Fat (non-surgical)	46.64 (7.27)
8-week %Fat (surgical)	45.94 (7.53)
16-week %Fat (non-surgical side)	47.00 (6.92)
16-week %Fat (surgical side)	47.03 (6.90)

Population analysed: The discrepancy in number of participants included (N=14) versus the number of participants analyzed in this outcome (n=7) is due to unavailability of the DXA scanner in the beginning of the study. Of note, all missed measures were reported to the IRB.

Primary outcome: Leg Muscles Lean Mass in Kilograms

Time frame: Baseline, 8 weeks and 16 weeks. Mean (Standard Deviation). Unit: Kilograms

Measure	Preoperative Exercises n = 7
Baseline_LeanMass (non-surgical)	5.47 (4.08)
Baseline_LeanMass (surgical)	5.63 (4.13)
8-week_LeanMass (non-surgical)	7.92 (1.36)
8-week_LeanMass (surgical)	7.98 (1.15)
16-week_LeanMass (non-surgical)	7.78 (1.31)
16-week_LeanMass (surgical)	7.85 (1.10)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preoperative Exercises	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Deidentified data will be shared with other researchers at UT Health San Antonio, with the NIH and on ClinicalTrials.gov

Related trials for Knee Osteoarthritis

RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis

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. This study is not recruiting at the moment.

Gustavo Almeida, PhD principal investigator

The University of Texas Health Science Center at San Antonio

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 (BFRT) in people with Knee Osteoarthritis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

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 3 inclusion and 19 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: finished, as of the sponsor's last update on 24 Mar 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 United States. 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?

Yes. Results are posted in the registry (first posted 24 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quadricep Muscle Strength (time frame: Baseline, 8 weeks and 16 weeks). The study lists 3 primary outcomes in all. 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 NCT06111690.

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 24 Mar 2026.