STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)
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|ClinicalTrials.gov Identifier: NCT02653768|
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Behavioral: Stepped Exercise Program Behavioral: Arthritis Education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||STepped Exercise Program for Knee Osteoarthritis (STEP-KOA)|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.
Behavioral: Stepped Exercise Program
STEP 1: Participants have access to an internet-based exercise program for knee OA.
STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.
STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit
Other Name: STEP-KOA
Active Comparator: Arthritis Education (AE)
Participants in the AE control group will receive low literacy educational materials via mail every two weeks. Because STEP-KOA is a multi-component intervention, with participants receiving different numbers of Steps, it is not possible to implement a control condition that will mirror the exact intervention "dose" received by all participants in the STEP-KOA group. However, AE will achieve the goal of providing an active, OA-related control condition.
Behavioral: Arthritis Education
The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to OA and its management, based on established treatment guidelines.
Other Name: AE
- Western Ontario and McMaster Universities Osteoarthritis Index -modified short form (mSF-WOMAC) [ Time Frame: Change from baseline to 3-month, 6-month, 9-month, and 15-month follow-ups ]This is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms).
- Objective Physical Function [ Time Frame: Change from baseline to 9-month follow-up ]These tests will include a 30 second stair stand test and a 40m fast-paced walk, following previously established procedures for each. The 30 second stair stand asks participants to rise and sit back down in a chair as many times as they can during that time period, without using hands or arms for support. The 40m fast-paced walk is a timed test of walking twice back and forth (as fast as participants are able) over a 10m distance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653768
|Contact: Kelli D Allen, PhD||(919) firstname.lastname@example.org|
|Contact: Battista Smith, MPH BS||(919) 286-0411 ext email@example.com|
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Kelli D Allen, PhD (919) 286-6936 firstname.lastname@example.org|
|Sub-Investigator: Courtney H Van Houtven, PhD|
|Sub-Investigator: Cynthia J Coffman, PhD|
|Sub-Investigator: Dennis Bongiorni, DPT|
|Sub-Investigator: Helen Hoenig, MD|
|Sub-Investigator: James C. Byrd, MD MPH|
|Sub-Investigator: Katherine Shepherd Hall, PhD|
|Principal Investigator: Kelli Dominick Allen, PhD|
|Sub-Investigator: Kim Huffman, MD|
|Sub-Investigator: Miriam C. Morey, PhD|
|Sub-Investigator: Nancy Jo Hodges, DPT|
|Principal Investigator:||Kelli Dominick Allen, PhD||Durham VA Medical Center, Durham, NC|