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Mobile Technology to Support Physical Therapy Exercise (MyTherEx)

Primary Purpose

Osteoarthritis of Knee, Osteoarthritis Of Hip

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Application
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Knee focused on measuring Exercise, mhealth, physical therapy

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Self-report of healthcare provider diagnosed osteoarthritis in the hips or knees
  2. Ability to speak and read English
  3. No diagnosis of serious mental illness
  4. No diagnosis of serious or terminal illness (e.g., metastatic cancer, end stage renal failure)
  5. Access to smartphone/tablet

Exclusion Criteria:

  1. Cortisone injection to the joint with OA within the past 30 days
  2. Undergoing physical therapy post-total joint replacement or in preparation for total joint replacement in the next 3 months
  3. History of physical therapy for treatment of osteoarthritis in the past 6 months.

Sites / Locations

  • Dee Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Application Group

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Exercise adherence
Mean weekly exercise frequency over 6 and 12 weeks:0-21 with higher scores indicating more adherence.

Secondary Outcome Measures

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
2 minute walk test
Functional exercise capacity: Score is in meters/feet with higher distances indicating better exercise capacity
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Pain measure: Scale range 0-100 with higher scores indicating worse pain
Timed Up and Go (TUG) + Dual Task
Measure of physical function: Score is in seconds with higher scores indicating worse physical function
Dynamic Balance: Four square balance test
Test of dynamic balance: Score is in seconds with lower scores indicating better dynamic balance
Self-efficacy for exercise (SEE) Scale
Self-Efficacy for Exercise Scale: Score range 0-90 with higher score indicating higher self-efficacy for exercise

Full Information

First Posted
February 5, 2018
Last Updated
September 27, 2021
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT03428893
Brief Title
Mobile Technology to Support Physical Therapy Exercise
Acronym
MyTherEx
Official Title
MyTherEx: Mobile Technology to Support Physical Therapist Directed Exercise for People Aging With Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee, Osteoarthritis Of Hip
Keywords
Exercise, mhealth, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Application Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Mobile Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise adherence
Description
Mean weekly exercise frequency over 6 and 12 weeks:0-21 with higher scores indicating more adherence.
Time Frame
0, 6, and 12 weeks
Secondary Outcome Measure Information:
Title
ShortMAC Physical Function Patient Reported Outcome MeasureRO
Description
12-item assessment of pain and function in people with osteoarthritis: 0-100 scale with higher scores for higher function and less pain
Time Frame
0, 6 and 12 weeks
Title
2 minute walk test
Description
Functional exercise capacity: Score is in meters/feet with higher distances indicating better exercise capacity
Time Frame
0, 6 and 12 weeks
Title
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Description
Pain measure: Scale range 0-100 with higher scores indicating worse pain
Time Frame
0, 6 and 12 weeks
Title
Timed Up and Go (TUG) + Dual Task
Description
Measure of physical function: Score is in seconds with higher scores indicating worse physical function
Time Frame
0, 6 and 12 weeks
Title
Dynamic Balance: Four square balance test
Description
Test of dynamic balance: Score is in seconds with lower scores indicating better dynamic balance
Time Frame
0, 6 and 12 weeks
Title
Self-efficacy for exercise (SEE) Scale
Description
Self-Efficacy for Exercise Scale: Score range 0-90 with higher score indicating higher self-efficacy for exercise
Time Frame
0, 6, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Gell, PT, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dee Physical Therapy
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05407
Country
United States

12. IPD Sharing Statement

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