Knee Osteoarthritis
Conditions
Keywords
Blood flow restriction training (BFRT), Preoperative exercise, Muscle function, Physical activity
Brief 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).
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.
Interventions
Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
Sponsors
The University of Texas Health Science Center at San Antonio
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a single group pre-post design study
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadricep Muscle Strength | Baseline, 8 weeks and 16 weeks | Quadricep Muscle Strength will be measured using an isokinetic dynamometer. Quadriceps femoris maximum voluntary isometric contraction (MVIC) as torque output (Nm) will be measured. Subjects will be seated in the dynamometer's chair with their knee at 60 degrees of flexion. |
| Leg Muscles Percentage of Fat Mass | Baseline, 8 weeks and 16 weeks | Leg muscles % fat mass will be measured using a DXA scan. |
| Leg Muscles Lean Mass in Kilograms | Baseline, 8 weeks and 16 weeks | Leg muscles lean mass in kilograms will be measured using a DXA scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-selected Gait Speed | Baseline, 8 weeks and 16 weeks | Subject will walk a 4-meter walkway at a self-selected pace. Time to complete task will be recorded. |
| Timed up and go Test | Baseline, 8 weeks and 16 weeks | Subject will get up from a chair, walk 3 meters, turn around and walk back to and sit on the chair. Time to complete task will be recorded. |
| 30-second Chair Stand Test | Baseline, 8 weeks and 16 weeks | Subject will perform sit-to-stand from a standard chair for 30 seconds. Number of times of completed sit-to-stand in 30 seconds will be recorded. |
| Stair Climb Test | Baseline, 8 weeks and 16 weeks | Subject will climb up and down a flight of stairs (11 steps). Time to complete task will be recorded. |
| 6-minute Walk Test | Baseline, 8 weeks and 16 weeks | Subjects will cover as much as they can while walking on a flat, unobstructed path for 6 minutes. |
| Patient-Reported Physical Outcomes Measurement Information System (PROMIS | Baseline, 8 weeks and 16 weeks | Patient-Reported Physical Outcome will be assessed using PROMIS® (Patient-Reported Outcomes Measurement Information System), which is used to evaluate and monitor physical, mental, and social health in persons with several conditions. This is a 20 item survey with each item scored from 1-5. Total possible scores range from 5-100 with a higher score indicating better physical function. |
| Health Related Quality of Life (RAND-36) | Baseline, 8 weeks and 16 weeks | The RAND-36 Questionnaire is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. All questions are scored on a scale from 0 (worst) to 100 (best), with 100 representing the highest level of functioning possible. Aggregate scores are calculated between 0-100 with higher scores representing better quality of life. |
| Real-time Physical Activity | Baseline, 8 weeks and 16 weeks | An activity monitor will be worn for 7 days and physical activity (i.e., daily number of steps) will be tracked. |
| Inflammatory Biomarkers | Baseline, 8 weeks and 16 weeks | Change in 'MILLIPLEX® MAP Human High Sensitivity T Cell Magnetic Bead Panel' to assess a panel of 8 inflammatory biomarkers: Interleukin (IL)-1β, IL-2, IL-5, IL-6, IL-10, IL-12p70, IL-13 and Interferon-γ. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGustavo Almeida, PhD
The University of Texas Health Science Center at San Antonio
Participant flow
Recruitment details
16 recruited; 2 did not meet in-person screening; 14 participated in the study.
Pre-assignment details
The 2 participants that did not meet in-person screening had a high Ankle-brachial Index (ABI \> 1.5), which makes it unsafe to participate in blood-flow restriction training.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 70.57 years STANDARD_DEVIATION 7.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
None listed