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The objective of this project is to examine the efficacy of an innovative Telehealth Physical Therapy (PT) program for adults with knee osteoarthritis (OA) to increase physical activity over 12 weeks in adults with knee OA compared to a control group receiving web-based resources about knee OA. One hundred individuals with knee osteoarthritis (OA), who are over the age of 45, and are also looking to move more, will be randomized into a brief or expanded intervention group. The control includes an online, guided video orientation from a physical therapist to web resources for strengthening exercises, physical activity, and pain management strategies for knee OA. The intervention includes up to 5 online consultations with a physical therapist over a 12-week period who will prescribe strengthening exercises, physical activity goals, and pain management strategies for knee OA.
Delaware PEAK (Physical therapy Exercise and Activity for Knee osteoarthritis) is a delivered remotely by a physical therapist over 5 one-on-one video conference (Zoom Platform) consultations lasting 45 to 60 minutes each over 12 weeks. Each consultation focuses on strengthening exercises, physical activity goals, and education to debunk common OA-related myths and misconceptions. Delaware PEAK utilizes a well-established behavioral counseling method, Motivational Interviewing, to increase self-efficacy (confidence) related to exercise, while delivering all aspects of the intervention.
The objective of this project is to examine the efficacy of Delaware PEAK to increase physical activity in adults with knee OA compared to a control group receiving web-based resources about knee OA and exercise. The rationale for our study is that there is a need to examine whether PEAK can directly target the mismatch between OA recommendations and practice patterns. Our central hypothesis is that Delaware PEAK will increase physical activity and will increase the belief that exercise is helpful and not harmful, compared with a control group receiving web-based OA treatment resources. Successful completion of this proposal will provide the evidence necessary to scale up this low-cost intervention, with the goal of increasing the number of adults who use exercise to manage their knee OA and thus reducing the burden of disease.
The primary endpoint of our study is to examine the efficacy of a physical therapist-delivered exercise intervention (Delaware PEAK) to increase MVPA over 12 weeks compared to a control group receiving web-based resources about knee OA and exercise.
The secondary analyses endpoint of our study is to examine the efficacy of a physical therapist-delivered exercise intervention (Delaware PEAK) to increase health beliefs in Physical Exercise and Physical Therapy, light physical activity (LPA), and steps per day, over 24 weeks compared to a control group receiving web-based resources about knee OA and exercise. We also will assess change in MVPA over 24 weeks.
Our exploratory endpoints include change in pain, symptoms, function in activities of daily living, function in sport and recreation, and quality of life over 12 weeks and 24 weeks. We will also examine change in treatment expectations before and after randomization. Lastly, we will examine change in treatment adherence from 12 to 24 weeks among those in the expanded intervention group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. |
|
| Control | Active Comparator | Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Moderate-to-vigorous Intensity Physical Activity | Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided. Units are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA | Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Treatment Beliefs of Physical Therapy: Positive | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. Scores of the TOA PT Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome: Change in Knee Pain (Visual Analogue Scale) | Change in knee pain will be measured using a single-item Visual Analog Scale (VAS) question in which the participant will indicate their pain in each knee. Scores range from 0-100 where 0 is no pain and 100 is the worst pain imaginable. An index knee to be used for analysis is defined as the knee with worse pain at baseline. Scores of the Knee pain Visual Analogue Scale are on a scale of 0 to 100 with higher scores mean worse outcome, i.e., more pain |
Inclusion Criteria:
meet the National Institute for Health and Care Excellence Osteoarthritis (NICE) clinical criteria:
have a history of knee pain for at least 12 weeks;
are interested in becoming more physically active;
have either a cell phone or laptop/desktop computer with broadband internet connection and working email address; and
are able to commit to the study for 12 weeks and willing to wear physical activity monitors
live in the contiguous United States
comfortable participating in a program delivered in English
is able to safely participate in a moderate-intensity exercise as determined by a pre-exercise screen questionnaire.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40258072 | Derived | White DK, Hinman RS, Liles S, Bye TV, Voinier D, Copson J, Schmitt LA, Bodt BA, Jakiela JT. A Telehealth Physical Therapy Intervention to Increase Physical Activity in Adults With Knee OA: The Delaware PEAK Randomized Controlled Trial. J Orthop Sports Phys Ther. 2025 May;55(5):377-385. doi: 10.2519/jospt.2025.13132. | |
| 37200067 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Expanded Intervention | Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Expanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate. |
| FG001 | Brief Intervention | Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Brief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 12 Weeks |
|
| |||||||||||||||||||||
| 12 Weeks to 24 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Expanded Intervention | Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Expanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate. |
| 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 in Moderate-to-vigorous Intensity Physical Activity | Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided. Units are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA | For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for > 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88. | Posted | Mean | 95% Confidence Interval | min/day of MVPA | Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome |
|
Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
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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 | Expanded Intervention | Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Expanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel White | University of Delaware | 302-831-7607 | dkw@udel.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jul 14, 2023 | Jul 14, 2023 | Prot_ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2024 | Sep 12, 2024 | SAP_007.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| Control | Behavioral | Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes. |
|
| Baseline, 12 weeks, and 24 weeks |
| Change in Treatment Beliefs of Physical Exercise: Positive | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. Scores of the TOA PE Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs | Baseline, 12 weeks, and 24 weeks |
| Change in Light Intensity Physical Activity (LPA) | Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in minutes/week of LPA between baseline and both follow-up timepoints. Minutes/day of LPA can range from 0 minutes/day to 1,440 minutes/day (24 hours x 60 minutes). | Baseline, 12 weeks, and 24 weeks |
| Change in Steps/Day | Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in average steps/day between baseline and both follow-up timepoints. Steps/day can be any value greater than or equal to 0. Valid data includes those who wore the ActiGraph for > 4 days. | Baseline, 12 weeks, and 24 weeks |
| Change in Treatment Beliefs of Physical Therapy: Negative | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. Scores of the TOA PT Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs | Baseline, 12 weeks, and 24 weeks |
| Change in Treatment Beliefs of Physical Exercise: Negative | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. Scores of the TOA PE Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs | Baseline, 12 weeks, and 24 weeks |
| Baseline, 12 weeks, and 24 weeks |
| Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Pain Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Pain, min 0, max 100, with higher scores representing a better outcome | Baseline, 12 weeks, and 24 weeks |
| Exploratory Outcome: Change in Treatment Expectations | The participant will complete a Treatment Expectations Question, which asks the participant how effective they expect the intervention to be for their knee. This question will be collected at the baseline timepoint: right before and right after randomization. Answers will be expressed as frequencies and percentages for each of the following categories: No effect at all, Minimal improvement, Moderate improvement, Large improvement, and Complete recovery, as well as reported as an increase, decrease, or no change in treatment expectations. Score ranges from 1 to 5 with higher scores representing higher expectations of improvement following treatment. | Baseline and after randomization |
| Exploratory Outcome: Change in Exercise Adherence Rating Scale (EARS) | For the Expanded Intervention, adherence to strengthening exercises and physical activity will be measured using the Exercise Adherence Rating Scale (EARS). The EARS includes 6 items whose total score ranges from 0 to 24, where a higher score indicates greater adherence. | 12 weeks and 24 weeks |
| Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Symptoms Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Symptoms, min 0, max 100, with higher scores representing a better outcome | Baseline, 12 weeks, and 24 weeks |
| Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) ADL Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS ADL, min 0, max 100, with higher scores representing a better outcome | Baseline, 12 weeks, and 24 weeks |
| Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Sports and Recreation Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Sports and Recreation, min 0, max 100, with higher scores representing a better outcome | Baseline, 12 weeks, and 24 weeks |
| Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Quality of Life Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Quality of Life, min 0, max 100, with higher scores representing a better outcome | Baseline, 12 weeks, and 24 weeks |
| Aily JB, Copson J, Voinier D, Jakiela J, Hinman R, Grosch M, Noonan C, Armellini M, Schmitt L, White M, White D. Understanding Recruitment Yield From Social Media Advertisements and Associated Costs of a Telehealth Randomized Controlled Trial: Descriptive Study. J Med Internet Res. 2023 May 18;25:e41358. doi: 10.2196/41358. |
| 36200390 | Derived | Jakiela JT, Voinier D, Hinman RS, Copson J, Schmitt LA, Leonard TR, Aily JB, Bodt BA, White DK. Comparing an Expanded Versus Brief Telehealth Physical Therapist Intervention for Knee Osteoarthritis: Study Protocol for the Delaware PEAK Randomized Controlled Trial. Phys Ther. 2023 Feb 1;103(2):pzac139. doi: 10.1093/ptj/pzac139. |
| NOT COMPLETED |
|
|
| BG001 | Brief Intervention | Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Brief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes. |
| BG002 | 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 |
|
| Weight | Participant weight in kg | Mean | Standard Deviation | kilograms |
|
| Height | Study participant height in meters | Mean | Standard Deviation | Meters |
|
| Body Mass Index | Mean | Standard Deviation | Kg/m squared |
|
| OG000 |
| Intervention |
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate. |
| OG001 | Control | Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes. |
|
|
| Secondary | Change in Treatment Beliefs of Physical Therapy: Positive | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. Scores of the TOA PT Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs | We analyzed our intention to treat (ITT) sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
| Secondary | Change in Treatment Beliefs of Physical Exercise: Positive | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. Scores of the TOA PE Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
| Secondary | Change in Light Intensity Physical Activity (LPA) | Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in minutes/week of LPA between baseline and both follow-up timepoints. Minutes/day of LPA can range from 0 minutes/day to 1,440 minutes/day (24 hours x 60 minutes). | For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for > 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88. | Posted | Mean | 95% Confidence Interval | min/day | Baseline, 12 weeks, and 24 weeks |
|
|
|
| Secondary | Change in Steps/Day | Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in average steps/day between baseline and both follow-up timepoints. Steps/day can be any value greater than or equal to 0. Valid data includes those who wore the ActiGraph for > 4 days. | For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for > 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88. | Posted | Mean | 95% Confidence Interval | Steps/day | Baseline, 12 weeks, and 24 weeks |
|
|
|
| Secondary | Change in Treatment Beliefs of Physical Therapy: Negative | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. Scores of the TOA PT Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
| Secondary | Change in Treatment Beliefs of Physical Exercise: Negative | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. Scores of the TOA PE Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
| Other Pre-specified | Exploratory Outcome: Change in Knee Pain (Visual Analogue Scale) | Change in knee pain will be measured using a single-item Visual Analog Scale (VAS) question in which the participant will indicate their pain in each knee. Scores range from 0-100 where 0 is no pain and 100 is the worst pain imaginable. An index knee to be used for analysis is defined as the knee with worse pain at baseline. Scores of the Knee pain Visual Analogue Scale are on a scale of 0 to 100 with higher scores mean worse outcome, i.e., more pain | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
| Other Pre-specified | Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Pain Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Pain, min 0, max 100, with higher scores representing a better outcome | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
| Other Pre-specified | Exploratory Outcome: Change in Treatment Expectations | The participant will complete a Treatment Expectations Question, which asks the participant how effective they expect the intervention to be for their knee. This question will be collected at the baseline timepoint: right before and right after randomization. Answers will be expressed as frequencies and percentages for each of the following categories: No effect at all, Minimal improvement, Moderate improvement, Large improvement, and Complete recovery, as well as reported as an increase, decrease, or no change in treatment expectations. Score ranges from 1 to 5 with higher scores representing higher expectations of improvement following treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and after randomization |
|
|
|
| Other Pre-specified | Exploratory Outcome: Change in Exercise Adherence Rating Scale (EARS) | For the Expanded Intervention, adherence to strengthening exercises and physical activity will be measured using the Exercise Adherence Rating Scale (EARS). The EARS includes 6 items whose total score ranges from 0 to 24, where a higher score indicates greater adherence. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks and 24 weeks |
|
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| Other Pre-specified | Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Symptoms Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Symptoms, min 0, max 100, with higher scores representing a better outcome | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
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| Other Pre-specified | Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) ADL Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS ADL, min 0, max 100, with higher scores representing a better outcome | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
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| Other Pre-specified | Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Sports and Recreation Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Sports and Recreation, min 0, max 100, with higher scores representing a better outcome | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
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| Other Pre-specified | Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Quality of Life Subscale | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Quality of Life, min 0, max 100, with higher scores representing a better outcome | We analyzed our intention to treat sample, which included all subjects who were randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
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| 0 |
| 51 |
| 0 |
| 51 |
| 44 |
| 51 |
| EG001 | Brief Intervention | Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Brief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes. | 0 | 52 | 3 | 52 | 10 | 52 |
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| Hip/Thigh | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Ankle/Foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |