Osteoarthritis of KneeMyTherExNCT03428893
Mobile Technology to Support Physical Therapy Exercise
A study testing Mobile Application in people with Osteoarthritis of Knee and Osteoarthritis Of Hip, run by University of Vermont at 1 site in United States.
Trial summary
Osteoarthritis is the leading cause of disability in the U.S, particularly in older adults. Exercise is an evidence-based treatment option that improves pain and disability outcomes in adults with osteoarthritis, but adherence to prescribed exercise is generally low. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Knee, Osteoarthritis Of Hip
- What is being tested?
- Mobile Application
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-report of healthcare provider diagnosed osteoarthritis in the hips or knees
- Ability to speak and read English
- No diagnosis of serious mental illness
- No diagnosis of serious or terminal illness (e.g., metastatic cancer, end stage renal failure)
- Access to smartphone/tablet
Who cannot join
- Cortisone injection to the joint with OA within the past 30 days
- Undergoing physical therapy post-total joint replacement or in preparation for total joint replacement in the next 3 months
- History of physical therapy for treatment of osteoarthritis in the past 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dee Physical Therapy
South Burlington, Vermont, 05407
About this study
Official title: MyTherEx: Mobile Technology to Support Physical Therapist Directed Exercise for People Aging With Arthritis
Osteoarthritis is the leading cause of disability in the U.S, particularly in older adults. Exercise is an evidence-based treatment option that improves pain and disability outcomes in adults with osteoarthritis, but adherence to prescribed exercise is generally low. Technology such as mobile applications (apps) for smartphones and tablets offers the potential to support exercise adherence through evidence-based components and enhanced communication between physical therapists and patients. The investigators aim to test mobile app-supported physical therapy exercise prescription compared to standard care. The investigators propose to use a two-arm randomized control trial with subjects in the intervention receiving mobile app-supported physical therapy exercise prescription and the control group receiving usual care physical therapy exercise prescription (paper handouts and verbal instruction). No known studies have assessed the impact of technological integration on adherence with PT exercises for OA. Current approaches such as therapist drawn pictures, hand-written or print-ready instructions do not account for patient communication preferences or ability to translate drawings into physical action. Mobile technology offers a potential solution to patient-centered care but has not been evaluated. This study will provide valuable information on effectiveness and user perspectives to key stakeholders such as patients, health care administrators, physical therapists and app designers.
Read the detailed description
Osteoarthritis (OA) is the leading cause of disability in the U.S. The rate of activity limitation due to OA is progressing faster than expected while prevalence is projected to increase as a result of the obesity epidemic and population aging, making it a major public health problem. Exercise is an evidence-based treatment option that improves pain and disability outcomes in adults with osteoarthritis, but previous research has shown that adherence to prescribed exercise is low. Referral to physical therapy is common for people with OA with the standard of care including exercise prescription through paper handouts with brief instruction and static pictures. Such approaches do not incorporate known determinants of behavior change related to exercise adherence.
Recent technology products such as mobile applications (apps) for phones and tablets offer the potential to enhance communication between physical therapists and patients. The investigators aim to test a pragmatic intervention focused on supporting people with osteoarthritis to remain engaged with an exercise program. The specific aims of the project are to:
- Compare the effectiveness of mobile app supported exercise prescription to usual care (paper exercise prescription) on exercise adherence among mid-life and older adults receiving similarly dosed physical therapy for lower extremity OA. The investigators will also examine secondary outcomes of exercise self-efficacy, physical function, stiffness, and pain.
- Examine the feasibility and acceptability of mobile app supported exercise prescription through recruitment and retention rates, satisfaction with care ratings, and qualitative feedback.
- Conditions
- Osteoarthritis of Knee, Osteoarthritis Of Hip
- Being tested
- Mobile Application
- Keywords
- Exercise, mhealth, physical therapy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationDevice
Participants will receive usual care physical therapy guided by Clinical Practice Guidelines and based on individual symptoms and need over 7 in-person visits. Measures will be collected by the physical therapist related to leg strength, balance, fitness, and mobility as part of the usual care physical therapy evaluation and follow-up. The treating physical therapist will negotiate the physical therapy intervention based on patient preferences and goals and assessment findings. Using clinical practice guidelines, the intervention for the research participants is expected to address deficits in strength, mobility, balance, and cardiovascular endurance. Exercise prescription will be provided using the Wellpepper physical therapy exercise prescription mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application Group | Experimental | The mobile app group will receive physical therapy as determined by the physical therapist and agree to receive the home exercise prescription using a mobile app on their phone or personal tablet Receives: Device: Mobile Application |
| Control | No intervention | The control group will receive physical therapy as determined by the physical therapist based on clinical practice guidelines and will receive the home exercise program in the traditional way through paper exercise handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise adherence
Mean weekly exercise frequency over 6 and 12 weeks:0-21 with higher scores indicating more adherence.
Measured: 0, 6, and 12 weeks
Secondary outcomes (6)
ShortMAC Physical Function Patient Reported Outcome MeasureRO
12-item assessment of pain and function in people with osteoarthritis: 0-100 scale with higher scores for higher function and less pain
Measured: 0, 6 and 12 weeks
2 minute walk test
Functional exercise capacity: Score is in meters/feet with higher distances indicating better exercise capacity
Measured: 0, 6 and 12 weeks
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Pain measure: Scale range 0-100 with higher scores indicating worse pain
Measured: 0, 6 and 12 weeks
Timed Up and Go (TUG) + Dual Task
Measure of physical function: Score is in seconds with higher scores indicating worse physical function
Measured: 0, 6 and 12 weeks
Dynamic Balance: Four square balance test
Test of dynamic balance: Score is in seconds with lower scores indicating better dynamic balance
Measured: 0, 6 and 12 weeks
Self-efficacy for exercise (SEE) Scale
Self-Efficacy for Exercise Scale: Score range 0-90 with higher score indicating higher self-efficacy for exercise
Measured: 0, 6, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start8 Jan 2018
- Primary completion30 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Gell, University of Vermont
- Investigators
- Nancy Gell, PT, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428893
- Sponsor's protocol ID
- 17_0663
- Acronym
- MyTherEx
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2018
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyTherEx: Mobile Technology to Support Physical Therapist Directed Exercise for People Aging With Arthritis
- ClinicalTrials.gov ID
- NCT03428893
- Acronym / sponsor ID
- MyTherEx / 17_0663
- Conditions
- Osteoarthritis of Knee, Osteoarthritis Of Hip
- Keywords
- Exercise, mhealth, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis is the leading cause of disability in the U.S, particularly in older adults. Exercise is an evidence-based treatment option that improves pain and disability outcomes in adults with osteoarthritis, but adherence to prescribed exercise is generally low. Technology such as mobile applications (apps) for smartphones and tablets offers the potential to support exercise adherence through evidence-based components and enhanced communication between physical therapists and patients. The investigators aim to test mobile app-supported physical therapy exercise prescription compared to standard care. The investigators propose to use a two-arm randomized control trial with subjects in the intervention receiving mobile app-supported physical therapy exercise prescription and the control group receiving usual care physical therapy exercise prescription (paper handouts and verbal instruction). No known studies have assessed the impact of technological integration on adherence with PT exercises for OA. Current approaches such as therapist drawn pictures, hand-written or print-ready instructions do not account for patient communication preferences or ability to translate drawings into physical action. Mobile technology offers a potential solution to patient-centered care but has not been evaluated. This study will provide valuable information on effectiveness and user perspectives to key stakeholders such as patients, health care administrators, physical therapists and app designers.
Detailed description
Osteoarthritis (OA) is the leading cause of disability in the U.S. The rate of activity limitation due to OA is progressing faster than expected while prevalence is projected to increase as a result of the obesity epidemic and population aging, making it a major public health problem. Exercise is an evidence-based treatment option that improves pain and disability outcomes in adults with osteoarthritis, but previous research has shown that adherence to prescribed exercise is low. Referral to physical therapy is common for people with OA with the standard of care including exercise prescription through paper handouts with brief instruction and static pictures. Such approaches do not incorporate known determinants of behavior change related to exercise adherence.
Recent technology products such as mobile applications (apps) for phones and tablets offer the potential to enhance communication between physical therapists and patients. The investigators aim to test a pragmatic intervention focused on supporting people with osteoarthritis to remain engaged with an exercise program. The specific aims of the project are to:
- Compare the effectiveness of mobile app supported exercise prescription to usual care (paper exercise prescription) on exercise adherence among mid-life and older adults receiving similarly dosed physical therapy for lower extremity OA. The investigators will also examine secondary outcomes of exercise self-efficacy, physical function, stiffness, and pain.
- Examine the feasibility and acceptability of mobile app supported exercise prescription through recruitment and retention rates, satisfaction with care ratings, and qualitative feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Group | Experimental | Device: Mobile ApplicationThe mobile app group will receive physical therapy as determined by the physical therapist and agree to receive the home exercise prescription using a mobile app on their phone or personal tablet |
| Control | No intervention | –The control group will receive physical therapy as determined by the physical therapist based on clinical practice guidelines and will receive the home exercise program in the traditional way through paper exercise handouts |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-report of healthcare provider diagnosed osteoarthritis in the hips or knees
- Ability to speak and read English
- No diagnosis of serious mental illness
- No diagnosis of serious or terminal illness (e.g., metastatic cancer, end stage renal failure)
- Access to smartphone/tablet
Key exclusion criteria (3 listed)
- Cortisone injection to the joint with OA within the past 30 days
- Undergoing physical therapy post-total joint replacement or in preparation for total joint replacement in the next 3 months
- History of physical therapy for treatment of osteoarthritis in the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile ApplicationParticipants will receive usual care physical therapy guided by Clinical Practice Guidelines and based on individual symptoms and need over 7 in-person visits. Measures will be collected by the physical therapist related to leg strength, balance, fitness, and mobility as part of the usual care physical therapy evaluation and follow-up. The treating physical therapist will negotiate the physical therapy intervention based on patient preferences and goals and assessment findings. Using clinical practice guidelines, the intervention for the research participants is expected to address deficits in strength, mobility, balance, and cardiovascular endurance. Exercise prescription will be provided using the Wellpepper physical therapy exercise prescription mobile app. | Device | Mobile Application Group |
Primary outcome
Exercise adherence
Time frame: 0, 6, and 12 weeks
Mean weekly exercise frequency over 6 and 12 weeks:0-21 with higher scores indicating more adherence.
6 secondary outcomes
ShortMAC Physical Function Patient Reported Outcome MeasureRO
Time frame: 0, 6 and 12 weeks
2 minute walk test
Time frame: 0, 6 and 12 weeks
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Time frame: 0, 6 and 12 weeks
Timed Up and Go (TUG) + Dual Task
Time frame: 0, 6 and 12 weeks
Dynamic Balance: Four square balance test
Time frame: 0, 6 and 12 weeks
Self-efficacy for exercise (SEE) Scale
Time frame: 0, 6, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Gell, PT, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application in people with Osteoarthritis of Knee and Osteoarthritis Of Hip, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise adherence (time frame: 0, 6, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.