Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06111690 | RECRUITING | Knee Osteoarthritis

Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement
Sponsor:

The University of Texas Health Science Center at San Antonio

Information provided by (Responsible Party):

Gustavo Almeida

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, and increases physical activity in older adults awaiting total knee replacement (TKR).

Condition or disease

Knee Osteoarthritis

Intervention/treatment

Blood Flow Restriction Training (BFRT)

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Feasibility of Prehabilitation Blood-flow Restriction Training in Individuals Awaiting Total Knee Replacement.
Actual Study Start Date : 2022-09-23
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2024-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. 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);
  • 2. are older than 60 years;
  • 3. speak fluent English to reliably complete the study questionnaires and understand study instructions.
Exclusion Criteria
  • 1. have a history of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis;
  • 2. 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);
  • 3. report of 2 or more falls within the past year;
  • 4. cannot walk a distance of 100 feet (30.5 meters) without an assistive device or need of a rest period;
  • 5. have bilateral TKR or undergoing TKR revision or other total joint replacement in the lower extremities; or
  • 6. 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);
  • 7. have a lower extremity amputation;
  • 8. are unable to comfortably bear weight on the affected knee;
  • 9. have a BMI above 40.
  • 10. 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);
  • 11. had additional surgery to the lower extremities within the past 12 months.
  • 12. a Folstein Mini-Mental State Examination score of \<24.
  • 13. have acute or terminal illness;
  • 14. are planning to have another TKR (primary on contralateral, or revision on same knee) within 4 months;
  • 15. are planning to relocate to another city within 4 months.
  • 16. Subjects with Sickle cell disease
  • 17. lymphedema or vascular access restrictions
  • 18. Subjects who have any on-going medical emergency
  • 19. An ankle-brachial index outside of the expected range 0.9 and 1.3
Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

Location Details

NCT06111690

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

UT Health San Antonio- Dept. of Physical Therapy

Saint Anthony, Texas, United States, 78229