Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments internet based exercise training, physical therapy
Sponsor University of North Carolina, Chapel Hill
Collaborator Patient-Centered Outcomes Research Institute
Start date November 2014
End date June 2017
Trial size 350 participants
Trial identifier NCT02312713, 14-1331

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
physical therapy
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
(Experimental)
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
internet based exercise training
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
(No Intervention)
no intervention

Primary Outcomes

Measure
Change from baseline to month 4 and month 4 to month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index score
time frame: baseline, 4 months, and 12 months

Secondary Outcomes

Measure
Change from baseline to month 4 and month 4 to month 12 in the Satisfaction with Physical Function Scale
time frame: baseline, 4 months, and 12 months
Change from baseline to month 4 and month 4 to month 12 in a grouping of tests to assess Objective Physical Function
time frame: baseline, 4 months, and 12 months
Change from baseline to month 4 and month 4 to month 12 in the Patient Health Questionnaire-8
time frame: baseline, 4 months, and 12 months
Change from baseline to month 4 and month 4 to month 12 in The Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: baseline, 4 months, and 12 months
Change from baseline to month 4 and month 4 to month 12 in The PROMIS Sleep-related Impairment Instrument
time frame: baseline, 4 months, and 12 months
Change from baseline to month 4 and month 4 to month 12 in The PROMIS Fatigue Instrument
time frame: baseline, 4 months, and 12 months
Change from baseline to month 4 and month 4 to month 12 in the The Brief Fear of Movement Scale
time frame: baseline, 4 months, and 12 months
Change from baseline to month 4 and month 4 to month 12 in the Physical Activity Scale for the Elderly (PASE)
time frame: baseline, 4 months, and 12 months
Change from baseline to month 4 and month 4 to month 12 in Additional Self-Report Physical Activity Items
time frame: baseline, 4 months, and 12 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
Principal investigator Kelli D Allen, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.