Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee, Exercise
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.
Interventions
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
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. | 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). The total scale range is 0-96, and higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-second Chair Stand | Change from baseline to 9-month follow-up | 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. Higher scores mean better outcome (e.g. more stands in 30 seconds). |
| 40m Fast-paced Walk | Change from baseline to 9-month follow-up | 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. Lower scores mean better outcome (e.g. faster walking speed). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| STEP-KOA 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.
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 | 230 |
| Arthritis Education (AE) The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines. | 115 |
| Total | 345 |
Baseline characteristics
| Characteristic | Arthritis Education (AE) | Total | STEP-KOA |
|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 11.1 | 60.0 years STANDARD_DEVIATION 10.3 | 59.9 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants | 333 Participants | 224 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 66 Participants | 208 Participants | 142 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 39 Participants | 111 Participants | 72 Participants |
| Sex: Female, Male Female | 15 Participants | 45 Participants | 30 Participants |
| Sex: Female, Male Male | 100 Participants | 300 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 230 | 0 / 115 |
| other Total, other adverse events | 3 / 230 | 0 / 115 |
| serious Total, serious adverse events | 23 / 230 | 7 / 115 |
Outcome results
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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). The total scale range is 0-96, and higher scores mean a worse outcome.
Time frame: 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.
Population: Intent to treat. Only the STEP-KOA group was assessed at 15 months. This was planned because the AE group could start receiving treatment after 9 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-KOA | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Mean change scores from baseline to 9-months | -5.46 units on a scale | Standard Error 1.15 |
| STEP-KOA | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Mean changes scores from baseline to 6-months | -3.97 units on a scale | Standard Error 1.2 |
| STEP-KOA | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Mean change scores from 9 months to 15-months | 3.02 units on a scale | Standard Error 1.38 |
| STEP-KOA | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Mean Change Scores from Baseline to 3-months | -4.85 units on a scale | Standard Error 1 |
| Arthritis Education (AE) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Mean changes scores from baseline to 6-months | -2.53 units on a scale | Standard Error 1.54 |
| Arthritis Education (AE) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Mean Change Scores from Baseline to 3-months | 0.26 units on a scale | Standard Error 1.27 |
| Arthritis Education (AE) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Mean change scores from baseline to 9-months | 1.38 units on a scale | Standard Error 1.49 |
30-second Chair Stand
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. Higher scores mean better outcome (e.g. more stands in 30 seconds).
Time frame: Change from baseline to 9-month follow-up
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STEP-KOA | 30-second Chair Stand | -0.23 Number of chair stands | Standard Error 0.29 |
| Arthritis Education (AE) | 30-second Chair Stand | -0.59 Number of chair stands | Standard Error 0.37 |
40m Fast-paced Walk
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. Lower scores mean better outcome (e.g. faster walking speed).
Time frame: Change from baseline to 9-month follow-up
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STEP-KOA | 40m Fast-paced Walk | -0.72 seconds | Standard Error 1.26 |
| Arthritis Education (AE) | 40m Fast-paced Walk | 1.61 seconds | Standard Error 1.57 |