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Completed

NCT Number: NCT03428893

Mobile Technology to Support Physical Therapy Exercise

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.

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Key information

Conditions

Osteoarthritis of Knee Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis of Hip Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dee Physical Therapy

South Burlington, Vermont, 05407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile application

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. ShortMAC Physical Function Patient Reported Outcome MeasureRO

    Time frame: 0, 6 and 12 weeks

    12-item assessment of pain and function in people with osteoarthritis: 0-100 scale with higher scores for higher function and less pain

  2. 2 minute walk test

    Time frame: 0, 6 and 12 weeks

    Functional exercise capacity: Score is in meters/feet with higher distances indicating better exercise capacity

  3. Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)

    Time frame: 0, 6 and 12 weeks

    Pain measure: Scale range 0-100 with higher scores indicating worse pain

  4. Timed Up and Go (TUG) + Dual Task

    Time frame: 0, 6 and 12 weeks

    Measure of physical function: Score is in seconds with higher scores indicating worse physical function

  5. Dynamic Balance: Four square balance test

    Time frame: 0, 6 and 12 weeks

    Test of dynamic balance: Score is in seconds with lower scores indicating better dynamic balance

  6. Self-efficacy for exercise (SEE) Scale

    Time frame: 0, 6, and 12 weeks

    Self-Efficacy for Exercise Scale: Score range 0-90 with higher score indicating higher self-efficacy for exercise

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study title

MyTherEx: Mobile Technology to Support Physical Therapist Directed Exercise for People Aging With Arthritis

Acronym: MyTherEx

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2018
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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