Back to resultsPhysical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis (PATH-IN)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet Based Exercise Training
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee Osteoarthritis
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
Sites / Locations
- UNC Thurston Arthritis Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
Standard Physical Therapy
Internet Based Exercise Training
Wait list control
Arm Description
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.
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.
no intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02312713
First Posted
October 20, 2014
Last Updated
September 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02312713
Brief Title
Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
Acronym
PATH-IN
Official Title
Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Physical Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Internet Based Exercise Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
Internet Based Exercise Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score
Description
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.
Time Frame
baseline, 4 months, and 12 months
Secondary Outcome Measure Information:
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)
Description
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.
Time Frame
baseline, 4 months, and 12 months
Title
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
Description
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.
Time Frame
baseline, 4 months, and 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli D Allen, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Thurston Arthritis Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33463020
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.
Results Reference
derived
PubMed Identifier
31254451
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.
Results Reference
derived
PubMed Identifier
30025540
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.
Results Reference
derived
PubMed Identifier
29307722
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.
Results Reference
derived
PubMed Identifier
28371481
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.
Results Reference
derived
PubMed Identifier
26416025
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.
Results Reference
derived
Learn more about this trial
Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
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