Walking and mHealth to Increase Participation in Parkinson Disease
NCT ID: NCT03517371
Last Updated: 2025-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2019-02-04
2024-03-06
Brief Summary
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Detailed Description
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Traditionally, rehabilitation has targeted impairments and functional limitations with the expectation that gains would translate into greater participation in real-world activities. However, the evidence suggests that this does not occur. In this proposal, the investigators suggest a paradigm shift in which the primary target of the intervention is real-world walking behavior, as greater walking activity could preserve walking function and slow disability. The primary factors that limit engagement in walking in PD are psychological (e.g., low self-efficacy) rather than physical (e.g., motor impairments) in nature. As such, investigators will evaluate a cognitive-behavioral approach, grounded in social-cognitive theory and targeted at enhancing walking activity. This "connected behavioral approach" links physical therapists to persons with PD using a mobile health (mHealth) platform to deliver strategies to increase self-efficacy and provide goal-oriented, dynamic walking routines and walking enhancing exercises over one year. This approach will be compared to a control intervention which provides equivalent components and dosing of walking and a walking enhancing exercise program delivered by physical therapists but without a cognitive-behavioral mHealth approach. Investigators hypothesize that the mHealth group will demonstrate higher amounts of walking activity and greater walking capacity relative to the control group. With regard to mechanism underlying improvements in the mHealth group, it is hypothesized that self-efficacy will mediate changes in amount of walking and that changes in amount of walking will mediate changes in walking capacity over one year. The insights to be gained regarding mechanisms underlying changes noted will be critical to inform rehabilitation interventions designed to encourage sustained, long-term physical activity. If effective, our "connected behavioral approach" offers a unique, generalizable and scalable means to increase walking activity and improve walking capacity, thereby reducing disability in PD and perhaps in other chronic progressive conditions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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mHealth delivered exercise program
Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature.
mHealth delivered exercise program
Participants in the mobile health condition have up to 8 in-person visits with a physical therapist over 12 months. The exercise program, consisting of walking, strengthening and stretching exercises, is prescribed through an "app" and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week.
Exercise only
Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided.
Exercise only
Participants in the control group have up to 8 in-person visits with the intervention physical therapist over 12-months. Participants are instructed by the physical therapist to engage in walking and perform progressive resistance and stretching exercises (tailored to their needs and provided in written format) 5 days per week.
Interventions
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mHealth delivered exercise program
Participants in the mobile health condition have up to 8 in-person visits with a physical therapist over 12 months. The exercise program, consisting of walking, strengthening and stretching exercises, is prescribed through an "app" and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week.
Exercise only
Participants in the control group have up to 8 in-person visits with the intervention physical therapist over 12-months. Participants are instructed by the physical therapist to engage in walking and perform progressive resistance and stretching exercises (tailored to their needs and provided in written format) 5 days per week.
Eligibility Criteria
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Inclusion Criteria
2. Hoehn \& Yahr stages 1-3 (mild to moderate disease severity);
3. Stable on all PD medications for at least 2 weeks prior to study entry;
4. Willing and able to provide informed consent.
Exclusion Criteria
2. Pregnant;
3. diagnosis of atypical Parkinsonism;
4. Hoehn \& Yahr stages 4-5
5. a score of \> 2 on item 7 of the new freezing of gait questionnaire (moderately or significantly disturbing freezing episodes during daily walking);
6. significant cognitive impairment;
7. unstable medical or concomitant illnesses or psychiatric conditions, which in the opinion of the investigators would preclude successful participation;
8. cardiac problems that interfere with ability to safely exercise
9. orthopedic problems in the lower extremities or spine that may limit walking distance;
10. unable to walk for 10 continuous minutes independently;
11. live in an institution or medical facility (i.e. not in the community)
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Boston University Charles River Campus
OTHER
Responsible Party
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Theresa D Ellis
Assistant Professor
Principal Investigators
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Theresa D Ellis, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Gammon M Earhart, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University
Boston, Massachusetts, United States
Washington University St. Louis
St Louis, Missouri, United States
Countries
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References
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Girnis JL, Cavanaugh JT, Baker TC, Duncan RP, Fulford D, LaValley MP, Lawrence M, Nordahl T, Porciuncula F, Rawson KS, Saint-Hilaire M, Thomas CA, Zajac JA, Earhart GM, Ellis TD. Natural Walking Intensity in Persons With Parkinson Disease. J Neurol Phys Ther. 2023 Jul 1;47(3):146-154. doi: 10.1097/NPT.0000000000000440. Epub 2023 Apr 4.
Zajac JA, Cavanaugh JT, Baker T, Colon-Semenza C, DeAngelis TR, Duncan RP, Fulford D, LaValley M, Nordahl T, Rawson KS, Saint-Hilaire M, Thomas CA, Earhart GM, Ellis TD. Are Mobile Persons With Parkinson Disease Necessarily More Active? J Neurol Phys Ther. 2021 Oct 1;45(4):259-265. doi: 10.1097/NPT.0000000000000362.
Rawson KS, Cavanaugh JT, Colon-Semenza C, DeAngelis T, Duncan RP, Fulford D, LaValley MP, Mazzoni P, Nordahl T, Quintiliani LM, Saint-Hilaire M, Thomas CA, Earhart GM, Ellis TD. Design of the WHIP-PD study: a phase II, twelve-month, dual-site, randomized controlled trial evaluating the effects of a cognitive-behavioral approach for promoting enhanced walking activity using mobile health technology in people with Parkinson-disease. BMC Neurol. 2020 Apr 20;20(1):146. doi: 10.1186/s12883-020-01718-z.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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