STepped Exercise Program for Knee OsteoArthritis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | July 1, 2016 |
| End Date: | July 31, 2019 |
STepped Exercise Program for Knee Osteoarthritis (STEP-KOA)
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.
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.
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.
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.
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
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