Clinical trial NCT06111690: Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement
Official title: Feasibility of Prehabilitation Blood-flow Restriction Training in Individuals Awaiting Total Knee Replacement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Blood flow restriction training (BFRT)
Preoperative exercise
Muscle function
Physical activity
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-11-01
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group pre-post design study
Primary purpose: PREVENTION

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).

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.

Eligibility 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

Primary outcomes:
measure: Quadricep Muscle Strength
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Thigh muscles composition
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Thigh muscle volume
timeFrame: Baseline, 8 weeks and 16 weeks
Secondary outcomes:
measure: Self-selected Gait Speed
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Timed up and go Test
timeFrame: Baseline, 8 weeks and 16 weeks
measure: 30-second chair stand test
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Stair climb test
timeFrame: Baseline, 8 weeks and 16 weeks
measure: 6-minute Walk Test
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Patient-Reported Physical Outcome
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Health Related Quality of Life (RAND-36)
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Real-time Physical Activity
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Inflammatory Biomarkers
timeFrame: Baseline, 8 weeks and 16 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio- Dept. of Physical Therapy
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Gustavo Almeida, PhD
role: PRINCIPAL_INVESTIGATOR
References: