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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Wait list control | No Intervention | no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli D Allen, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Thurston Arthritis Research Center | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37527856 | Derived | 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. | |
| 33463020 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Physical Therapy | 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. |
| FG001 | Internet Based Exercise Training | 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. |
| FG002 | Wait List Control | no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Physical Therapy | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 4 months, and 12 months |
|
Data were collected for 12 months, ending at participants' final follow up time point.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Physical Therapy | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis of left foot | Infections and infestations | Non-systematic Assessment |
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelli Allen | University of North Carolina at Chapel HIll | 919-966-0558 | kdallen@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2017 | Aug 18, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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|
| 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. |
|
| 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | baseline, 4 months, and 12 months |
| 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. | baseline, 4 months, and 12 months |
| 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 | baseline, 4 months, and 12 months |
| 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. | baseline, 4 months, and 12 months |
| 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. | baseline, 4 months, and 12 months |
| 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. | baseline, 4 months, and 12 months |
| 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. | baseline, 4 months, and 12 months |
| 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. | baseline, 4 months, and 12 months |
| 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. |
| 31254451 | 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. |
| 30025540 | 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. |
| 29307722 | 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. |
| 28371481 | 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. |
| 26416025 | 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. |
| BG001 | Internet Based Exercise Training | 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. |
| BG002 | Wait List Control | no intervention |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Married or Living with Partner | Count of Participants | Participants |
|
| Bachelors Degree or More Education | Count of Participants | Participants |
|
| Employed | Count of Participants | Participants |
|
| Low Income Financial Status | "Low income" defined as self report of "just meeting basic expenses" or "don't even have enough to meet basic expenses" vs. responses of "live comfortably or "meet your basic expenses with a little left over for extras" in response to a question asking participants to "describe your household's financial situation." | Count of Participants | Participants |
|
| Fair or Poor Self-Reported Health | Participants were asked, "How would you rate your current health?" Options were: excellent, very good, good, fair and poor. For this metric we grouped those reporting fair or poor. | Count of Participants | Participants |
|
| Number of Joints with Arthritis Symptoms | Mean | Standard Deviation | joints |
|
| Self-reported Years with Arthritis Symptoms | Mean | Standard Deviation | years |
|
| OG001 | Internet Based Exercise Training | 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. |
| OG002 | Wait List Control | no intervention |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | number of steps taken in 2 minutes | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | seconds | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | number of stands from a chair in 30 sec | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | seconds | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 4 months, and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | minutes per week | baseline, 4 months, and 12 months |
|
|
|
|
| 0 |
| 140 |
| 8 |
| 140 |
| 0 |
| 140 |
| EG001 | Internet Based Exercise Training | 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. | 2 | 142 | 12 | 142 | 0 | 142 |
| EG002 | Wait List Control | no intervention | 0 | 68 | 9 | 68 | 0 | 68 |
| Chronic Leukemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pulmonary Embolism | Vascular disorders | Non-systematic Assessment |
|
| Shortness of breath, CHF exacerbation, pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Left femoral hernia resulting in small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Posterior Lumbar Decompression & Fusion Surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Heart Blockage | Cardiac disorders | Non-systematic Assessment |
|
| Stage 1 Uterine Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Total Knee Replacement | Surgical and medical procedures | Non-systematic Assessment |
|
| Heart Attack | Cardiac disorders | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | Non-systematic Assessment |
|
| Cataract Surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Pacemaker implant for Sick sinus syndrome | Surgical and medical procedures | Non-systematic Assessment | with symptomatic bradycardia |
|
| Odontoid fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sepsis from E.Coli UTI | Infections and infestations | Non-systematic Assessment |
|
| C1 Cervical Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Laproscopy w/total hysterectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Laparoscopic cholecystectomy for cholelithiasis | Surgical and medical procedures | Non-systematic Assessment |
|
| Appendicitis with peritoneal abscess | Infections and infestations | Non-systematic Assessment |
|
| MRSA bacteremia | Infections and infestations | Non-systematic Assessment |
|
| Anaphylaxis after insect bites | Immune system disorders | Non-systematic Assessment |
|
| Fall with fracture of right shoulder and right wrist pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| C. Diff Colitis | Infections and infestations | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
|
| Mixed Models Analysis |
| 0.28 |
| Mean Difference (Final Values) |
| 0.23 |
| 2-Sided |
| 95 |
| -0.19 |
| 0.65 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months. | Mixed Models Analysis | 0.75 | Mean Difference (Final Values) | 0.07 | 2-Sided | 95 | -0.35 | 0.49 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months. | Mixed Models Analysis | 0.22 | Mean Difference (Final Values) | 0.27 | 2-Sided | 95 | -0.16 | 0.7 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months. | Mixed Models Analysis | 0.00 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.84 | -0.16 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months. | Mixed Models Analysis | 0.83 | Mean Difference (Final Values) | 0.04 | 2-Sided | 95 | -0.31 | 0.39 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| Baseline to 12 Month Change |
|
| Mixed Models Analysis |
| 0.78 |
| Mean Difference (Final Values) |
| 1.12 |
| 2-Sided |
| 95 |
| -6.59 |
| 8.82 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for the 2 Minute Step Test. | Mixed Models Analysis | 0.20 | Mean Difference (Final Values) | 4.88 | 2-Sided | 95 | -2.56 | 12.33 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for the 2 Minute Step Test. | Mixed Models Analysis | .78 | Mean Difference (Final Values) | 1.13 | 2-Sided | 95 | -6.74 | 8.99 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for the 2 Minute Step Test. | Mixed Models Analysis | 0.35 | Mean Difference (Final Values) | -2.86 | 2-Sided | 95 | -8.94 | 3.21 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for the 2 Minute Step Test. | Mixed Models Analysis | 1.00 | Mean Difference (Final Values) | 0.01 | 2-Sided | 95 | -6.40 | 6.42 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
|
| Mixed Models Analysis |
| 0.93 |
| Mean Difference (Final Values) |
| 0.04 |
| 2-Sided |
| 95 |
| -0.89 |
| 0.98 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Unilateral Stand Time. | Mixed Models Analysis | 0.97 | Mean Difference (Final Values) | -0.02 | 2-Sided | 95 | -0.97 | 0.93 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Unilateral Stand Time | Mixed Models Analysis | 0.93 | Mean Difference (Final Values) | 0.04 | 2-Sided | 95 | -0.91 | 1 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Unilateral Stand Time. | Mixed Models Analysis | 0.12 | Mean Difference (Final Values) | 0.61 | 2-Sided | 95 | -0.16 | 1.38 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Unilateral Stand Time. | Mixed Models Analysis | 1.00 | Mean Difference (Final Values) | 0.00 | 2-Sided | 95 | -0.78 | 0.77 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
|
| Mixed Models Analysis |
| 0.37 |
| Mean Difference (Final Values) |
| -0.49 |
| 2-Sided |
| 95 |
| -1.58 |
| 0.6 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for 30 Second Chair Stand. | Mixed Models Analysis | 0.62 | Mean Difference (Final Values) | 0.32 | 2-Sided | 95 | -0.95 | 1.59 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for 30 Second Chair Stand. | Mixed Models Analysis | 0.67 | Mean Difference (Final Values) | 0.24 | 2-Sided | 95 | -0.87 | 1.35 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for 30 Second Chair Stand. | Mixed Models Analysis | 0.23 | Mean Difference (Final Values) | 0.63 | 2-Sided | 95 | -0.40 | 1.66 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for 30 Second Chair Stand. | Mixed Models Analysis | 0.11 | Mean Difference (Final Values) | 0.74 | 2-Sided | 95 | -0.17 | 1.64 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| Baseline to 12 Month Change |
|
| Mixed Models Analysis |
| 0.46 |
| Mean Difference (Final Values) |
| -0.5 |
| 2-Sided |
| 95 |
| -1.86 |
| 0.85 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Timed Up and Go. | Mixed Models Analysis | 0.3 | Mean Difference (Final Values) | -0.64 | 2-Sided | 95 | -1.85 | 0.58 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Timed Up and Go. | Mixed Models Analysis | 0.08 | Mean Difference (Final Values) | -1.22 | 2-Sided | 95 | -2.61 | 0.16 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Timed Up and Go. | Mixed Models Analysis | 0.63 | Mean Difference (Final Values) | -0.24 | 2-Sided | 95 | -1.23 | 0.74 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Timed Up and Go. | Mixed Models Analysis | 0.21 | Mean Difference (Final Values) | -0.72 | 2-Sided | 95 | -1.85 | 0.41 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
|
| Mixed Models Analysis |
| 0.05 |
| Mean Difference (Final Values) |
| -0.9 |
| 2-Sided |
| 95 |
| -1.82 |
| 0.02 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months. | Mixed Models Analysis | 0.19 | Mean Difference (Final Values) | -0.55 | 2-Sided | 95 | -1.37 | 0.27 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months. | Mixed Models Analysis | 0.06 | Mean Difference (Final Values) | -0.89 | 2-Sided | 95 | -1.83 | 0.05 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months. | Mixed Models Analysis | 0.49 | Mean Difference (Final Values) | 0.23 | 2-Sided | 95 | -0.43 | 0.89 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months. | Mixed Models Analysis | 0.99 | Mean Difference (Final Values) | 0 | 2-Sided | 95 | -0.77 | 0.78 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| Baseline to 12 Month Change - KOOS Pain |
|
| Baseline to 4 Month Change - KOOS ADL |
|
| Baseline to 12 Month Change - KOOS ADL |
|
| Baseline to 4 Month Change - KOOS Sport/Rec |
|
| Baseline to 12 Month Change - KOOS Sport/Rec |
|
| Baseline to 4 Month Change - KOOS QOL |
|
| Baseline to 12 Month Change - KOOS QOL |
|
| This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months for KOOS Pain. | Mixed Models Analysis | 0.17 | Mean Difference (Final Values) | 2.51 | 2-Sided | 95 | -1.11 | 6.14 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Pain. | Mixed Models Analysis | 0.06 | Mean Difference (Final Values) | 3.94 | 2-Sided | 95 | -0.19 | 8.06 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Pain. | Mixed Models Analysis | 0.14 | Mean Difference (Final Values) | 3.36 | 2-Sided | 95 | -1.08 | 7.79 | Superiority |
| This is the comparison between Standard Physical Therapy and Wait List Control at 4 months for KOOS Pain. | Mixed Models Analysis | 0.25 | Mean Difference (Final Values) | 2.37 | 2-Sided | 95 | -1.67 | 6.4 | Superiority |
| This is the comparison between Standard Physical Therapy and Wait List Control at 12 months for KOOS Pain. | Mixed Models Analysis | 0.70 | Mean Difference (Final Values) | 0.85 | 2-Sided | 95 | -3.48 | 5.18 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS ADL. | Mixed Models Analysis | 0.40 | Mean Difference (Final Values) | -1.32 | 2-Sided | 95 | -4.43 | 1.79 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS ADL. | Mixed Models Analysis | 0.84 | Mean Difference (Final Values) | 0.33 | 2-Sided | 95 | -2.93 | 3.59 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 month for KOOS ADL. | Mixed Models Analysis | 0.28 | Mean Difference (Final Values) | 2.11 | 2-Sided | 95 | -1.73 | 5.94 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 month for KOOS ADL. | Mixed Models Analysis | 0.17 | Mean Difference (Final Values) | 2.79 | 2-Sided | 95 | -1.2 | 6.77 | Superiority |
| This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS ADL. | Mixed Models Analysis | 0.07 | Mean Difference (Final Values) | 3.43 | 2-Sided | 95 | -0.32 | 7.18 | Superiority |
| This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS ADL. | Mixed Models Analysis | 0.22 | Mean Difference (Final Values) | 2.45 | 2-Sided | 95 | -1.44 | 6.34 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Sport/Rec. | Mixed Models Analysis | .92 | Mean Difference (Final Values) | -0.21 | 2-Sided | 95 | -4.47 | 4.06 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS Sport/Rec. | Mixed Models Analysis | .82 | Mean Difference (Final Values) | .55 | 2-Sided | 95 | -4.15 | 5.24 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Sport/Rec. | Mixed Models Analysis | 0.17 | Mean Difference (Final Values) | 3.71 | 2-Sided | 95 | -1.59 | 9 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Sport/Rec. | Mixed Models Analysis | 0.04 | Mean Difference (Final Values) | 6.01 | 2-Sided | 95 | 0.29 | 11.74 | Superiority |
| This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS Sport/Rec. | Mixed Models Analysis | 0.14 | Mean Difference (Final Values) | 3.91 | 2-Sided | 95 | -1.28 | 9.1 | Superiority |
| This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS Sport/Rec. | Mixed Models Analysis | 0.05 | Mean Difference (Final Values) | 5.47 | 2-Sided | 95 | -0.1 | 11.03 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS QOL. | Mixed Models Analysis | .86 | Mean Difference (Final Values) | .33 | 2-Sided | 95 | -3.29 | 3.96 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS QOL. | Mixed Models Analysis | 0.15 | Mean Difference (Final Values) | 2.59 | 2-Sided | 95 | -0.96 | 6.13 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS QOL. | Mixed Models Analysis | 0.11 | Mean Difference (Final Values) | 3.63 | 2-Sided | 95 | -0.85 | 8.11 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS QOL. | Mixed Models Analysis | 0 | Mean Difference (Final Values) | 7.74 | 2-Sided | 95 | 3.39 | 12.08 | Superiority |
| This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS QOL. | Mixed Models Analysis | 0.14 | Mean Difference (Final Values) | 3.29 | 2-Sided | 95 | -1.08 | 7.67 | Superiority |
| This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS QOL. | Mixed Models Analysis | 0.02 | Mean Difference (Final Values) | 5.15 | 2-Sided | 95 | 0.92 | 9.37 | Superiority |
| Baseline to 12 Month Change |
|
| Mixed Models Analysis |
| 0.33 |
| Mean Difference (Final Values) |
| -1.06 |
| 2-Sided |
| 95 |
| -3.22 |
| 1.09 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months. | Mixed Models Analysis | 0.72 | Mean Difference (Final Values) | -0.39 | 2-Sided | 95 | -2.52 | 1.74 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months. | Mixed Models Analysis | 0.56 | Mean Difference (Final Values) | 0.65 | 2-Sided | 95 | -1.56 | 2.86 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months. | Mixed Models Analysis | 0.01 | Mean Difference (Final Values) | 2.19 | 2-Sided | 95 | 0.48 | 3.9 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months. | Mixed Models Analysis | 0.06 | Mean Difference (Final Values) | 1.71 | 2-Sided | 95 | -0.1 | 3.52 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
|
| Mixed Models Analysis |
| 0.01 |
| Mean Difference (Final Values) |
| -2.43 |
| 2-Sided |
| 95 |
| -4.31 |
| -0.55 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months. | Mixed Models Analysis | 0.39 | Mean Difference (Final Values) | -0.99 | 2-Sided | 95 | -3.24 | 1.27 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months. | Mixed Models Analysis | 0.1 | Mean Difference (Final Values) | -1.65 | 2-Sided | 95 | -3.58 | 0.29 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months. | Mixed Models Analysis | 0.11 | Mean Difference (Final Values) | 1.48 | 2-Sided | 95 | -0.33 | 3.29 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months. | Mixed Models Analysis | 0.33 | Mean Difference (Final Values) | 0.79 | 2-Sided | 95 | -0.8 | 2.37 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
|
| Mixed Models Analysis |
| 1.00 |
| Mean Difference (Net) |
| 0 |
| 2-Sided |
| 95 |
| -0.77 |
| 0.77 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months. | Mixed Models Analysis | 0.31 | Mean Difference (Final Values) | -0.44 | 2-Sided | 95 | -1.29 | 0.41 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months. | Mixed Models Analysis | 0.58 | Mean Difference (Final Values) | -0.22 | 2-Sided | 95 | -1.01 | 0.57 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months. | Mixed Models Analysis | 0.32 | Mean Difference (Final Values) | 0.35 | 2-Sided | 95 | -0.33 | 1.03 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months. | Mixed Models Analysis | 0.51 | Mean Difference (Final Values) | -0.22 | 2-Sided | 95 | -0.86 | 0.43 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| Baseline to 12 Month Change |
|
| Mixed Models Analysis |
| 0.41 |
| Mean Difference (Final Values) |
| 7.11 |
| 2-Sided |
| 95 |
| -9.69 |
| 23.91 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months. | Mixed Models Analysis | 0.50 | Mean Difference (Final Values) | -6.82 | 2-Sided | 95 | -26.55 | 12.91 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months. | Mixed Models Analysis | 0.43 | Mean Difference (Final Values) | 7.02 | 2-Sided | 95 | -10.31 | 24.35 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months. | Mixed Models Analysis | 0.09 | Mean Difference (Final Values) | -13.77 | 2-Sided | 95 | -29.73 | 2.19 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months. | Mixed Models Analysis | 0.99 | Mean Difference (Final Values) | -0.09 | 2-Sided | 95 | -14.41 | 14.23 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| Baseline to 12 Month Change - Strengthening Exerc |
|
| Baseline to 4 Month Change - Stretching |
|
| Baseline to 12 Month Change - Stretching |
|
| Baseline to 4 Month Change - Aerobic Exercises |
|
| Baseline to 12 Month Change - Aerobic Exercises |
|
| Mixed Models Analysis |
| 0.09 |
| Mean Difference (Final Values) |
| 1.21 |
| 2-Sided |
| 95 |
| -0.18 |
| 2.6 |
| Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Strengthening Exercises. | Mixed Models Analysis | 0.22 | Mean Difference (Final Values) | 0.85 | 2-Sided | 95 | -0.49 | 2.19 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Strengthening Exercises. | Mixed Models Analysis | 0.06 | Mean Difference (Final Values) | 1.35 | 2-Sided | 95 | -0.08 | 2.78 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Strength. | Mixed Models Analysis | 0.36 | Mean Difference (Final Values) | -0.51 | 2-Sided | 95 | -1.6 | 0.58 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Strength. | Mixed Models Analysis | 0.81 | Mean Difference (Final Values) | 0.14 | 2-Sided | 95 | -1.03 | 1.31 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Wait List Control at 4 months for Stretching. | Mixed Models Analysis | 0.00 | Mean Difference (Final Values) | 1.85 | 2-Sided | 95 | 0.67 | 3.03 | Superiority |
| This is the comparison between Physical Therapy and Wait List Control at 12 months for Stretching. | Mixed Models Analysis | 0.00 | Mean Difference (Final Values) | 1.62 | 2-Sided | 95 | 0.55 | 2.68 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Stretching. | Mixed Models Analysis | 0.03 | Mean Difference (Final Values) | 1.37 | 2-Sided | 95 | 0.16 | 2.57 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Stretching. | Mixed Models Analysis | 0.00 | Mean Difference (Final Values) | 2.07 | 2-Sided | 95 | 0.98 | 3.16 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Stretching. | Mixed Models Analysis | 0.33 | Mean Difference (Final Values) | -0.48 | 2-Sided | 95 | -1.46 | 0.5 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Stretching. | Mixed Models Analysis | 0.32 | Mean Difference (Final Values) | 0.45 | 2-Sided | 95 | -0.44 | 1.34 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Wait List Control at 4 months for Aerobic Exercise. | Mixed Models Analysis | 0.21 | Mean Difference (Final Values) | 1.09 | 2-Sided | 95 | -0.61 | 2.8 | Superiority |
| This is the comparison between Physical Therapy and Wait List Control at 12 months for Aerobic Exercise. | Mixed Models Analysis | 0.04 | Mean Difference (Final Values) | 2.07 | 2-Sided | 95 | 0.13 | 4 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Aerobic Exercise. | Mixed Models Analysis | 0.03 | Mean Difference (Final Values) | 1.89 | 2-Sided | 95 | 0.15 | 3.62 | Superiority |
| This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Aerobic Exercise. | Mixed Models Analysis | 0.05 | Mean Difference (Final Values) | 1.99 | 2-Sided | 95 | 0.01 | 3.97 | Superiority |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Aerobic Exercise. | Mixed Models Analysis | 0.27 | Mean Difference (Final Values) | 0.79 | 2-Sided | 95 | -0.62 | 2.2 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |
| This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Aerobic Exercise. | Mixed Models Analysis | 0.93 | Mean Difference (Final Values) | -0.07 | 2-Sided | 95 | -1.69 | 1.54 | Non-Inferiority | Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol. |