BACKGROUND/RATIONALE:
Knee osteoarthritis (OA) is a leading cause of pain and disability among veterans, and Department of Veterans Affairs health care users are the most severely affected. There is ample evidence that exercise improves pain, function, and other outcomes among patients with knee OA. However, the vast majority of individuals with knee OA are physically inactive. There is clearly a need to develop and implement programs that efficiently and effectively foster regular physical activity and improve key patient-centered outcomes among veterans with knee OA.

OBJECTIVE(S):
The objective of this study is to evaluate the effectiveness a novel STepped Exercise Program for Knee OsteoArthritis (STEP-KOA). This clinical trial will have the following specific aims: 1) To examine the effectiveness of STEP-KOA on key patient-centered outcomes among Veterans with symptomatic knee OA. 2) To estimate maintenance effects of STEP-KOA at 15-month follow-up, six months following completion of the program. 3) To describe patients who are non-responders at each Step in the STEP-KOA group, and to examine patient characteristics associated with non-response. 4) To examine the cost effectiveness of overall STEP-KOA intervention, compared with an Arthritis Education Control group.

METHODS:
This will be a randomized controlled trial of n=345 veterans with symptomatic knee OA in two VISN 6 sites, with participants assigned to two study arms: STEP-KOA and Arthritis Education Control (AE). STEP-KOA will begin with three months of access to a low-resource, internet-based exercise training program that uses patient-specific information to determine and deliver an appropriate personalized exercise plan (Step 1). Participants who do not meet response criteria for clinically meaningful improvement in pain and function after three months of Step 1 will additionally receive telephone calls from an exercise counselor for three months, to facilitate adherence and address barriers to physical activity (Step 2). Participants who still fail to meet response criteria after Step 2 will receive in-person physical therapy visits, which address specific functional impairments and further tailor exercise recommendations (Step 3). Outcomes will be assessed at baseline, 3 months, 6 months, and 9 months (primary outcome time point). Participants in the STEP-KOA group will also be asked to complete assessments at 15 months to evaluate maintenance of any observed treatment effects. Veterans in the AE group will be offered participation in Steps 1 and 2 of STEP-KOA after completing 9-month assessments. The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), a measure of lower extremity pain, stiffness and function. The secondary outcomes will be objective measures of physical function. The main study analyses will compare the STEP-KOA intervention to the AE control condition at follow-up time points. We will also evaluate patient characteristics associated with the need for progression to each Step, and will conduct a cost-effectiveness analysis of STEP-KOA.

FINDINGS/RESULTS:
No finding to date.

IMPACT:
The study will have an important impact for Veterans because it evaluates a novel, patient-centered approach to improving physical activity and related outcomes for knee OA - one of the most common and disabling health problems. The study will have an important impact for VA because the STEP-KOA could be a practical approach for both improving access to physical activity interventions and targeting more costly and limited PT resources for knee OA in an evidence-based manner.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001546-01A2
Link: https://reporter.nih.gov/project-details/8976973

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PUBLICATIONS:

Journal Articles

1. Beauchamp T, Arbeeva L, Cleveland RJ, Golightly YM, Hales DP, Hu DG, Allen KD. Accelerometer-Based Physical Activity Patterns and Associations With Outcomes Among Individuals With Osteoarthritis. Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases. 2022 Mar 1; 28(2):e415-e421. [view]
2. Kaufman BG, Allen KD, Coffman CJ, Woolson S, Caves K, Hall K, Hoenig HM, Huffman KM, Morey MC, Hodges NJ, Ramasunder S, van Houtven CH. Cost and Quality of Life Outcomes of the STepped Exercise Program for Patients With Knee OsteoArthritis Trial. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2022 Apr 1; 25(4):614-621. [view]
3. Boucher NA, Zullig LL, Shepherd-Banigan M, Decosimo KP, Dadolf J, Choate A, Mahanna EP, Sperber NR, Wang V, Allen KA, Hastings SN, Van Houtven CH. Replicating an effective VA program to train and support family caregivers: a hybrid type III effectiveness-implementation design. BMC health services research. 2021 May 6; 21(1):430. [view]
4. Allen KD, Bongiorni D, Caves K, Coffman CJ, Floegel TA, Greysen HM, Hall KS, Heiderscheit B, Hoenig HM, Huffman KM, Morey MC, Ramasunder S, Severson H, Smith B, Van Houtven C, Woolson S. STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial. BMC musculoskeletal disorders. 2019 May 28; 20(1):254. [view]
5. Allen KD, Woolson S, Hoenig HM, Bongiorni D, Byrd J, Caves K, Hall KS, Heiderscheit B, Hodges NJ, Huffman KM, Morey MC, Ramasunder S, Severson H, Van Houtven C, Abbate LM, Coffman CJ. Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial. Annals of internal medicine. 2021 Mar 1; 174(3):298-307. [view]

DRA: Musculoskeletal Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Cost-Effectiveness, Exercise, Functional Status, Health Promotion and Education, Outcomes - Patient, Pain, Rehabilitation
MeSH Terms: none