Clinical trial NCT02312713: Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
Official title: Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Knee Osteoarthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-12-09
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score
timeFrame: baseline, 4 months, and 12 months
Secondary outcomes:
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)
timeFrame: baseline, 4 months, and 12 months
measure: Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
timeFrame: baseline, 4 months, and 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Thurston Arthritis Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kelli D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coffman CJ, Arbeeva L, Schwartz TA, Callahan LF, Golightly YM, Goode AP, Huffman KM, Allen KD. Application of Heterogeneity of Treatment-Effects Methods: Exploratory Analyses of a Trial of Exercise-Based Interventions for Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2022 Aug;74(8):1359-1368. doi: 10.1002/acr.24564. Epub 2022 May 2.
citation: Flowers PPE, Schwartz TA, Arbeeva L, Golightly YM, Pathak A, Cooke J, Gupta JJ, Callahan LF, Goode AP, Corsi M, Huffman KM, Allen KD. Racial Differences in Performance-Based Function and Potential Explanatory Factors Among Individuals With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2020 Sep;72(9):1196-1204. doi: 10.1002/acr.24018.
citation: Pignato M, Arbeeva L, Schwartz TA, Callahan LF, Cooke J, Golightly YM, Goode AP, Heiderscheit BC, Hill C, Huffman KM, Severson HH, Allen KD. Level of participation in physical therapy or an internet-based exercise training program: associations with outcomes for patients with knee osteoarthritis. BMC Musculoskelet Disord. 2018 Jul 19;19(1):238. doi: 10.1186/s12891-018-2139-y.
citation: Allen KD, Arbeeva L, Callahan LF, Golightly YM, Goode AP, Heiderscheit BC, Huffman KM, Severson HH, Schwartz TA. Physical therapy vs internet-based exercise training for patients with knee osteoarthritis: results of a randomized controlled trial. Osteoarthritis Cartilage. 2018 Mar;26(3):383-396. doi: 10.1016/j.joca.2017.12.008. Epub 2018 Jan 5.
citation: Gunn AH, Schwartz TA, Arbeeva LS, Callahan LF, Golightly Y, Goode A, Hill CH, Huffman K, Iversen MD, Pathak A, Taylor SS, Allen KD. Fear of Movement and Associated Factors Among Adults With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2017 Dec;69(12):1826-1833. doi: 10.1002/acr.23226. Epub 2017 Nov 6.
citation: Williams QI, Gunn AH, Beaulieu JE, Benas BC, Buley B, Callahan LF, Cantrell J, Genova AP, Golightly YM, Goode AP, Gridley CI, Gross MT, Heiderscheit BC, Hill CH, Huffman KM, Kline A, Schwartz TA, Allen KD. Physical therapy vs. internet-based exercise training (PATH-IN) for patients with knee osteoarthritis: study protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2015 Sep 28;16:264. doi: 10.1186/s12891-015-0725-9.