Status:
COMPLETED
Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The aim is to demonstrate that preoperative exercises (prehabilitation) using blood-flow restriction training (BFRT) is safe, well tolerated, improves muscle function, decreases functional limitation,...
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 B...
Eligibility Criteria
Inclusion
- 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
- 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);
- 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
Key Trial Info
Start Date :
September 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06111690
Start Date
September 23 2022
End Date
December 2 2024
Last Update
March 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT Health San Antonio- Dept. of Physical Therapy
San Antonio, Texas, United States, 78229