Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis

University of North Carolina, Chapel Hill1 site in 1 country350 target enrollmentNovember 2014

ConditionsKnee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: University of North Carolina, Chapel Hill
Enrollment: 350
Locations: 1
Primary Endpoint: Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

June 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of North Carolina, Chapel Hill

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score

Time Frame: baseline, 4 months, and 12 months

Change over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function.

Secondary Outcomes

Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale(baseline, 4 months, and 12 months)
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument(baseline, 4 months, and 12 months)