Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement
Purpose
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
- Knee Osteoarthritis
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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); 2. are older than 60 years; 3. 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; 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is a single group pre-post design study
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Preoperative Exercises |
Intervention is blood flow restriction training (BFRT) |
|
Recruiting Locations
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
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.