N/A
N=350
Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02312713 ↗Enrolled (actual)
350
Serious AEs
8.3%
Results posted
Oct 2017
Primary outcome: Primary: Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score — -6.73; -6.06; -3.37; -4.42 units on a scale — p=0.06
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internet Based Exercise Training (Behavioral); Physical Therapy (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score |
-6.73; -6.06; -3.37; -4.42; -5.46; -2.83 | 0.06 |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale |
0.84; 0.35; 0.28; 0.39; 0.43; 0.16 | 0.01 sig |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test |
-0.68; -3.54; -8.43; 1.11; 1.12; 0.00 | 0.04 sig |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time |
-0.59; 0.02; 0.04; -0.05; -0.05; -0.09 | 0.19 |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand |
-0.13; 0.50; 0.18; 0.16; 0.90; 0.66 | 0.63 |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go |
-0.62; -0.87; -0.23; -0.77; -1.49; -0.26 | 0.52 |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8 |
-0.46; -0.22; 0.33; 0.1; 0.1; 0.99 | 0.05 |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) |
6.2; 7.77; 3.84; 3.67; 6.18; 2.82 | 0.36 |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument |
-3.13; -0.94; -0.54; -2.16; -0.45; -1.1 | 0.02 sig |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument |
-0.91; 0.57; 1.55; 0.09; 0.88; 2.52 | 0.03 sig |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale |
-0.34; 0.01; 0.45; 0.28; 0.06; 0.28 | 0.06 |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE) |
2.25; -11.52; -4.7; 8.28; 8.19; 1.17 | 0.48 |
| SECONDARY Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items |
1.78; 1.27; 0.43; 1.07; 1.21; -0.14 | 0.04 sig |
Summary
The purpose of this study is to examine the effectiveness of standard physical therapy and an internet-based exercise program for people with knee osteoarthritis (OA). Both of these programs will be compared to a "waiting list" control group. The investigators hypothesize that both treatments will result in greater improvement than the control condition and that the treatments will be similarly effective. The investigators also expect that some patients may do better with one treatment type or another and will explore this.
Eligibility Criteria
Inclusion Criteria
- Knee Osteoarthritis
Exclusion Criteria
- no internet access
- rheumatoid arthritis, lupus, or any other rheumatic condition
- severe fibromyalgia
- gout in your knees
- on a waiting list for joint replacement surgery, or are you planning to have joint replacement surgery during the next year
- total knee replacement surgery, other knee surgery, a torn meniscus in your knee, or a torn ACL in your knee during the past 6 months
- hospitalized for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 3 months
- currently undergoing physical therapy for knee OA
- meeting current recommendations for physical activity levels
- participating in another interventional study related to knee osteoarthritis or a study that involves physical activity
Data sourced from ClinicalTrials.gov (NCT02312713). 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.