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

NCT02312713 | Completed Results

• 1 other identifier: 14-1331
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline, 4 months, and 12 months

Secondary Outcomes (12)

• 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 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 Objective Physical Function - 30 Second Chair Stand

  baseline, 4 months, and 12 months

• 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

Study Arms (3)

Standard Physical Therapy

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.

Behavioral: Physical Therapy

Internet Based Exercise Training

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.

Behavioral: Internet Based Exercise Training

Wait list control

NO INTERVENTION

no intervention

Interventions

Internet Based Exercise Training BEHAVIORAL

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.

Internet Based Exercise Training

Physical Therapy BEHAVIORAL

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.

Standard Physical Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee Osteoarthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (7)

• Kim S, Kosorok MR, Arbeeva L, Schwartz TA, Callahan LF, Golightly YM, Nelson AE, Allen KD. Precision Medicine-Based Machine Learning Analyses to Explore Optimal Exercise Therapies for Individuals With Knee Osteoarthritis: Random Forest-Informed Tree-Based Learning. J Rheumatol. 2023 Oct;50(10):1341-1345. doi: 10.3899/jrheum.2022-1039. Epub 2023 Aug 1.

  PMID: 37527856 DERIVED

• 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.

  PMID: 33463020 DERIVED

• 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.

  PMID: 31254451 DERIVED

• 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.

  PMID: 30025540 DERIVED

• 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.

  PMID: 29307722 DERIVED

• 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.

  PMID: 28371481 DERIVED

• 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.

  PMID: 26416025 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Limitations and Caveats

1.) No new radiographs were conducted. 2) No assessment of adherence to home exercise. 3) This study was conducted in one geographic region and only included participants with regular internet access, which may limit generalizability.

Results Point of Contact

• Title: Kelli Allen
• Organization: University of North Carolina at Chapel HIll

kdallen@email.unc.edu

919-966-0558

Study Officials

• Kelli D Allen, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: December 9, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 27, 2017
• Results First Posted: October 27, 2017

Record last verified: 2017-06

Locations

US (1)