KAATSU Training to Enhance Physical Function of Older Adults With Osteoarthritis (KAATSU-OA)

University of Florida

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Behavioral: KAATSU exercise

Behavioral: Resistance Exercise

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02132715

IRB201400300

1R21AR065039-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

As the U.S. population ages and the prevalence of osteoarthritis (OA) among older adults rises, the prevention of OA-associated disability is an important public health priority. Accordingly, efficacious interventions are needed to manage pain and maintain physical function among older adults with OA. Because skeletal muscle weakness is a primary contributory factor to the progression of pain and functional decline among persons with OA, optimal interventions are those capable of improving skeletal muscle strength. High-intensity resistance exercise is the best-known method of improving muscle strength; however high-compressive loads typically induce significant joint pain among persons with OA. Accordingly, current recommendations include the performance of low- or moderate-intensity physical exercise - despite the fact that these training paradigms are sub-optimal for enhancing muscle strength. This application proposes conduct a pilot study to investigate the potential of an innovative training paradigm with potential to stimulate improvements in skeletal muscle strength while utilizing low-intensity loads. This paradigm, known as KAATSU training, involves performing low-intensity exercise while externally-applied compression mildly restricts blood flow to the active skeletal muscle. The overarching objective of the present application is to evaluate the efficacy and feasibility of chronic KAATSU training for the improvement of skeletal muscle strength and physical function among persons aged > 60 years with symptomatic knee OA and mild to moderate physical limitations. Up to 72 participants will be recruited to participate in this three month intervention study. Participants will be randomly assigned to one of two intervention conditions: (1) a standard exercise intervention consisting of center-based, moderate-intensity resistance training, or (2) a KAATSU training program matched for overall workload. This study will provide novel information regarding the therapeutic potential of KAATSU training for improving strength and function as well as attenuating pain among these individuals. The study will also provide critical information regarding the long-term, clinical viability of the paradigm by evaluating participant safety, discomfort, and willingness to continually engage in the KAATSU training program.

Enrollment

35 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 60 years and older
Radiographic evidence of osteophytes
Moderate to severe pain score (41-90 mm) recorded on 100-mm visual analog scale after 50-ft walk
Bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence grade 2 or 3
OA of the target knee
Score ≤ 10 on the Short Physical Performance Battery, as an indicator of physical limitation
Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire
Willingness to participate in all study procedures

Exclusion criteria

Failure to provide informed consent;
Regular participation in resistance exercise training within the past 3 months
Current involvement in supervised rehabilitation program
Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines
Diagnosed peripheral vascular disease
Ankle-brachial index < 0.95
Resting office systolic blood pressure > 160 mm Hg or < 100 mm Hg
Diastolic blood pressure > 100 mm Hg
History or family history of thrombosis
Resistant hypertension, defined by BP > 140/90 despite use of 3 or more antihypertensive medications
Severe cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina
Deep venous thrombosis
Known peripheral neuropathy
History of rheumatoid arthritis
Lower limb amputation
Lives in a nursing home; (persons living in assisted or independent housing will not be excluded)
Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental State Examination exam score < 24
Unable to communicate because of severe hearing loss or speech disorder;
Severe visual impairment, which would preclude completion of the assessments and/or intervention
Other significant co-morbid disease that would impair ability to participate in the exercise intervention
Lives outside of the study site or is planning to move out of the area during the study timeframe
Simultaneous participation in another intervention trial