Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement (NCT06111690) | Clinical Trial Compass
CompletedNot Applicable
Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement
United States16 participantsStarted 2022-09-23
Plain-language 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).
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quadricep Muscle Strength
Timeframe: Baseline, 8 weeks and 16 weeks
2
Leg Muscles Percentage of Fat Mass
Timeframe: Baseline, 8 weeks and 16 weeks
3
Leg Muscles Lean Mass in Kilograms
Timeframe: Baseline, 8 weeks and 16 weeks
Trial details
NCT IDNCT06111690
SponsorThe University of Texas Health Science Center at San Antonio
. 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);
. have a lower extremity amputation;
. are unable to comfortably bear weight on the affected knee;