Clinical trial NCT02653768: STepped Exercise Program for Knee OsteoArthritis
Official title: STepped Exercise Program for Knee Osteoarthritis (STEP-KOA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Exercise
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-01-12
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among Veterans. Although exercise is known to improve pain, physical abilities, and other outcomes for patients who have knee OA, most individuals with this condition are physically inactive. Therefore there is a need to develop programs that will help Veterans and others with knee OA to increase activity levels. This study will examine a stepped approach to helping Veterans with knee OA to increase physical activity, with increasing levels of program intensity when needed for individual patients to meaningfully improve pain and physical function.

Detailed description: 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. This objective of this study is to evaluate the effectiveness a novel STepped Exercise Program for Knee OsteoArthritis (STEP-KOA).

This will be a randomized controlled trial of n=345 Veterans with symptomatic knee OA in two VA Integrated Networks (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). Veterans in the AE group will be offered participation in STEP-KOA after completing study 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. The investigators will also evaluate patient characteristics associated with the need for progression to each Step and will conduct a cost-effectiveness analysis of STEP-KOA. This stepped exercise intervention is matched with patient needs, and it also provides the VA with a potential approach for focusing limited physical therapy resources toward patients who do not respond adequately to initial, less resource intensive and costly strategies to improve physical activity and related outcomes.

Eligibility criteria: Inclusion Criteria:

* Veteran enrolled at the Durham VA Medical Center (VAMC)
* Physician diagnosis of knee osteoarthritis
* Current knee joint symptoms

Exclusion Criteria:

* Currently meeting physical activity guidelines
* Currently completing Physical Therapy (PT) visits for knee OA
* Gout (in knee)
* Rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
* Dementia
* Psychosis
* Active substance abuse disorder
* Meniscus or anterior cruciate ligament (ACL) tear in the past 6 months
* Total joint replacement, other major lower extremity surgery in the past 6 months or planned in the next 9 months
* Severe hearing impairment
* Serious/terminal illness
* Other health problem that would prohibit participation in the study and/or warrant immediate PT
* Current participation in another OA intervention study
* Unstable angina
* History of ventricular tachycardia
* Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)
* Uncontrolled hypertension (diastolic blood pressure \>110 mm/Hg or systolic \> 200mm/Hg)
* Stroke with moderate to severe aphasia

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Change from baseline to 3-month, 6-month, 9-month follow-ups. For STEP-KOA only, change from 9-month to 15-month follow-up.
Secondary outcomes:
measure: 30-second Chair Stand
timeFrame: Change from baseline to 9-month follow-up
measure: 40m Fast-paced Walk
timeFrame: Change from baseline to 9-month follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Kelli Dominick Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Musculoskelet Disord. 2019 May 28;20(1):254. doi: 10.1186/s12891-019-2627-8.
citation: 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 Serv Res. 2021 May 6;21(1):430. doi: 10.1186/s12913-021-06448-7.
citation: Hughes JM, Bartle JT, Choate AL, Mahanna EP, Meyer CL, Tucker MC, Wang V, Allen KD, Van Houtven CH, Hastings SN. Walking All over COVID-19: The Rapid Development of STRIDE in Your Room, an Innovative Approach to Enhance a Hospital-Based Walking Program during the Pandemic. Geriatrics (Basel). 2021 Nov 10;6(4):109. doi: 10.3390/geriatrics6040109.
citation: 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. J Clin Rheumatol. 2022 Mar 1;28(2):e415-e421. doi: 10.1097/RHU.0000000000001750.
citation: 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. Ann Intern Med. 2021 Mar;174(3):298-307. doi: 10.7326/M20-4447. Epub 2020 Dec 29.
citation: 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 Health. 2022 Apr;25(4):614-621. doi: 10.1016/j.jval.2021.09.018. Epub 2021 Oct 29.