N/A
N=345
STepped Exercise Program for Knee OsteoArthritis
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT02653768 ↗Enrolled (actual)
345
Serious AEs
8.7%
Results posted
Apr 2020
Primary outcome: Primary: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) — -4.85; 0.26; -3.97; -2.53 units on a scale — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stepped Exercise Program (Behavioral); Arthritis Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
-4.85; 0.26; -3.97; -2.53; -5.46; 1.38 | 0.0003 sig |
| SECONDARY 30-second Chair Stand |
-0.23; -0.59 | 0.43 |
| SECONDARY 40m Fast-paced Walk |
-0.72; 1.61 | 0.23 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02653768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.