N/A
N=16
Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT06111690 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Quadricep Muscle Strength — 86.15; 76.55; 91.03; 80.32 torque newton-meter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood Flow Restriction Training (BFRT) (Procedure)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quadricep Muscle Strength |
86.15; 76.55; 91.03; 80.32; 85.24; 55.49 | — |
| PRIMARY Leg Muscles Percentage of Fat Mass |
47.88; 47.28; 46.64; 45.94; 47.00; 47.03 | — |
| PRIMARY Leg Muscles Lean Mass in Kilograms |
5.47; 5.63; 7.92; 7.98; 7.78; 7.85 | — |
| SECONDARY Self-selected Gait Speed |
0.91; 0.93; 0.88 | — |
| SECONDARY Timed up and go Test |
13.90; 12.47; 12.83 | — |
| SECONDARY 30-second Chair Stand Test |
7.50; 9.07; 7.86 | — |
| SECONDARY Stair Climb Test |
34.36; 28.34; 37.15 | — |
| SECONDARY 6-minute Walk Test |
369.43; 395.87; 346.59 | — |
| SECONDARY Patient-Reported Physical Outcomes Measurement Information System (PROMIS |
60.00; 57.50; 56.15 | — |
| SECONDARY Health Related Quality of Life (RAND-36) |
71.79; 71.07; 76.54 | — |
| SECONDARY Real-time Physical Activity |
— | — |
| SECONDARY Inflammatory Biomarkers |
— | — |
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).
Eligibility Criteria
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);
- 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
Data sourced from ClinicalTrials.gov (NCT06111690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.