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Knee OsteoarthritisPATH-INNCT02312713

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

A study testing Internet Based Exercise Training and Physical Therapy in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Internet Based Exercise Training and Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteUnited States
Study dates
Nov 2014to Jun 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Knee Osteoarthritis

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UNC Thurston Arthritis Research Center

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Being tested
Internet Based Exercise Training, Physical Therapy
Keywords
Osteoarthritis, Knee Osteoarthritis
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet Based Exercise TrainingBehavioural

    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 TherapyBehavioural

    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.

Study groups in NCT02312713
Study groupRoleWhat they receive
Standard Physical TherapyActive comparatorParticipants 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.
Receives: Behavioral: Physical Therapy
Internet Based Exercise TrainingExperimentalParticipants 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.
Receives: Behavioral: Internet Based Exercise Training
Wait list controlNo interventionno intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, 4 months, and 12 months

Secondary outcomes (12)
  1. Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale

    This is a validated, 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying). All 5 items are rated on a 7 point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). The total scale ranges from -15 to +15,with higher scores indicating greater satisfaction with function.

    Measured: baseline, 4 months, and 12 months

  2. Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test

    One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 2 minute step test, the minimum is 0 steps and there is no maximum scale score (participants complete as many steps as they can in 2 minutes); greater steps indicate better function.

    Measured: baseline, 4 months, and 12 months

  3. Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time

    One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the unilateral stand test, scores scan range from 0-10 seconds, with higher time indicating better balance.

    Measured: baseline, 4 months, and 12 months

  4. Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand

    One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 30 second chair stand test, the minimum is 0 stands and there is no maximum scale score (participants complete as many stands as they can in 30 seconds; greater numbers of stands indicate better function.

    Measured: baseline, 4 months, and 12 months

  5. Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go

    One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the timed up and go, there are no minimum or maximum scores (participants complete the task as quickly as they are able); shorter (lower) times indicate better function.

    Measured: baseline, 4 months, and 12 months

  6. Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8

    Depressive symptoms and severity will be assessed using the PHQ-8, a reliable and valid measure of depression71. The PHQ-8 is an eight-item survey derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic tool, and consists of items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV). Each of the eight questions is scored as 0 (not at all) to 3 (nearly every day), so that total scores range from 0 to 24, with higher scores indicating more depressive symptoms.

    Measured: baseline, 4 months, and 12 months

  7. Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)

    The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale

    Measured: baseline, 4 months, and 12 months

  8. Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument

    The PROMIS adult sleep related impairment item bank focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. It assesses sleep-related impairment over the past seven days. This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 30.5-77.6; higher scores indicate worse sleep impairment.

    Measured: baseline, 4 months, and 12 months

  9. Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument

    The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. It assesses fatigue over the past seven days, This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 33.1-77.8; higher scores indicate worse fatigue.

    Measured: baseline, 4 months, and 12 months

  10. Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale

    The Brief Fear of Movement Scale is a six item scale for assessing fear of movement in OA. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." The score ranges from 0-24 with higher scores indicating more fear of movement.

    Measured: baseline, 4 months, and 12 months

  11. Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)

    The Physical Activity Scale for the Elderly (PASE) is a self-report, 12-item scale that measures level occupational, household, and leisure activity during a one-week period. This scale was particularly developed for use among older adults; although all participants in the proposed study will not be age 65 or over, patients with knee OA typically have more limited physical activity than the general population. Therefore we believe this scale will be more applicable to our participant group than scales that were developed for younger adults.

    The typical range for the total PASE score is 0-400, with higher scores indicating greater activity.

    Measured: baseline, 4 months, and 12 months

  12. Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items

    Number of minutes per week, on average, they are completing strengthening, stretching, and aerobic exercises. The minimum score is 0, and there is no maximum score; higher scores indicate more weekly activity.

    Measured: baseline, 4 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02312713
Sponsor's protocol ID
14-1331
Acronym
PATH-IN
Status last verified
Jun 2017
First submitted
20 Oct 2014
Last updated
27 Oct 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 37527856
  • 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.

    PubMed 33463020
  • 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.

    PubMed 31254451
  • 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.

    PubMed 30025540
  • 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.

    PubMed 29307722
  • 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.

    PubMed 28371481
  • 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.

    PubMed 26416025

Questions about this trial

What is this clinical trial studying?

A study testing Internet Based Exercise Training and Physical Therapy in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02312713, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.

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