STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial.

Abstract

Background

Physical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.

Methods / design

Step-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.

Discussion

STEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.

Trial registration

Clinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1186/s12891-019-2627-8

Publication Info

Allen, Kelli D, Dennis Bongiorni, Kevin Caves, Cynthia J Coffman, Theresa A Floegel, Heather M Greysen, Katherine S Hall, Bryan Heiderscheit, et al. (2019). STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial. BMC musculoskeletal disorders, 20(1). p. 254. 10.1186/s12891-019-2627-8 Retrieved from https://hdl.handle.net/10161/26146.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Allen

Kelli Dominick Allen

Adjunct Professor in the Department of Medicine
  • Improving care and outcomes for individuals with osteoarthritis and other musculoskeletal conditions with an emphasis on non-pharmacological therapies including physical activity, weight management, rehabilitation services, and pain coping
    * Understanding rand reducing disparities in musculoskeletal conditions
    * Musculoskeletal conditions in U.S. military Veterans
    * Pragmatic clinical trials
    * Adaptive interventions
Coffman

Cynthia Jan Coffman

Professor of Biostatistics & Bioinformatics
Hall

Katherine Shepherd Hall

Associate Professor in Medicine

My research is focused on developing evidence-based physical activity interventions for older adults with an eye to preserving functional independence and quality of life. I am particularly interested in developing exercise programs to promote physical and psychological well-being among older veterans with posttraumatic stress disorder (PTSD). 

Hoenig

Helen Marie Hoenig

Professor of Medicine
  1. General Focus and Goals of Research: Dr. Hoenig's research focuses on rehabilitation, and more specifically on assistive technology and teletechnology. Patient populations of interest include geriatric patients with diverse medical problems including stroke, spinal and/or musculoskeletal disorders.

    2. Specific Approaches or Techniques: Randomized controlled trials, epidemiological studies including large data base analyses and survey research. Clinical trials include studies of the effects of motorized scooters in persons with difficulty walking, methods for providing wheelchairs, and telerehabilitation for exercise & functional mobility training in the home. Epidemiological studies and survey research have examined use of assistive technology and other coping strategies to disability.

    4. Special areas of expertise/national recognition: Rehabilitation health services research, geriatric rehabilitation, assistive technology outcomes, telerehabilitation.

    KEY WORDS/PHRASES: Rehabilitation, Process and Outcomes Research, Assistive Technology, Telehealth, Activities of Daily Living, Geriatrics, Disability.
Morey

Miriam C. Morey

Professor Emeritus of Medicine

The general focus of Dr. Morey's work is exercise and aging. All of her research examines how physical activity, exercise training, or physical fitness influence the physical functioning and/or pyschosocial quality of life of older adults. She directs a supervised hospital-based program for older adults, which is used to examine longitudinally the effects of exercise training on the musculoskeletal, articular, and cardiorespiratory systems. Furthermore, she has a number of studies that examine how system-wide impairments serve as preclinical indicators of disability and overall decline in the quality of life of older adults. Ongoing studies examine the role of exercise training in attenuation or reversal of functional decline and examination of the effectivenes of different methods of physical activity counseling for home-based exercise.
Dr. Morey's research evolves directly from three sources: (1) primary analyses of clinical trials regarding the impact of exercise on a specific outcome, (2) longitudinal analyses of participants in ongoing clinical exercise programs, and (3) secondary analyses of clinical trials which involve exercise or physical activity.
Although physical activity and exercise are the interventions of interest in all of these studies, the outcomes of interest vary considerably. Within the broad domain of aging, Dr. Morey has examined the impact of exercise on physical performance, well-being, sleep quality, disability, and functional limitations. More recently, Dr. Morey has several studies focusing on the effect of tailored telephone physical activity counseling to improve function in elders. Specific studies are targeted to newly diagnosed cancer survivors, long-term cancer survivors, and frail elders in geriatric and primary care settings.
Dr. Morey's expertise is in the area of exercise physiology and aging. She has specific knowledge in age-related changes in cardiorespiratory functioning, the effects of habitual exercise (longitudinal) on performance, and exercise programming for older adults.


Key Words: Exercise, maximal oxygen uptake, cardiorespiratory fitness, aging, disability,
functional limitations, longitudinal

Van Houtven

Courtney Harold Van Houtven

Professor in Population Health Sciences

Dr. Courtney Van Houtven is a Professor in The Department of Population Health Science, Duke University School of Medicine and Duke-Margolis Center for Health Policy. She is also a Research Career Scientist in The Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System. Dr. Van Houtven’s aging and economics research interests encompass long-term care financing, intra-household decision-making, unpaid family and friend care, and home- and community-based services. She examines how family caregiving affects health care utilization, expenditures, health and work outcomes of care recipients and caregivers. She is also interested in understanding how best to support family caregivers to optimize caregiver and care recipient outcomes.

Dr. Van Houtven  is co-PI on the QUERI Program Project, “Optimizing Function and Independence”, in which her caregiver skills training program developed as an RCT in VA, now called Caregivers FIRST, has been implemented at 125 VA sites nationally. The team will evaluate how intensification of an implementation strategy changes adoption. She directs the VA-CARES Evaluation Center, which evaluates the VA’s Caregiver Support Program. She leads a mixed methods R01 study as PI from the National Institute on Aging that will assess the value of "home time" for persons living with dementia and their caregivers (RF1 AG072364).


Areas of expertise: Health Services Research and Health Economics


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