KAATSU Training to Enhance Physical Function of Older Adults With Osteoarthritis

NCT02132715 | Completed DMC

• 2 other identifiers: IRB2014003001R21AR065039-01A1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in isokinetic muscle strength

  6 weeks post-randomization, 12 weeks post-randomization

Secondary Outcomes (4)

• Change in Short Physical Performance Battery score

  12-weeks post-randomization

• Change in self-paced walking speed

  6 weeks-post randomization, 12 weeks post-randomization

• Change in Late Life Disability Questionnaire score

  12 weeks post-randomization

• Change in Western Ontario and McMaster Osteoarthritis Index score

  12 weeks post-randomization

Study Arms (2)

Resistance exercise

ACTIVE COMPARATOR

Traditional isotonic lower-extremity resistance training

Behavioral: Resistance Exercise

KAATSU exercise

EXPERIMENTAL

Lower-extremity exercise with blood flow mildly restricted

Behavioral: KAATSU exercise

Interventions

Resistance Exercise BEHAVIORAL

Resistance exercise

KAATSU exercise BEHAVIORAL

KAATSU exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Thomas Buford, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 7, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 23, 2016

Record last verified: 2016-04

Locations

US (1)