Walking and mHealth to Increase Participation in Parkinson Disease

NCT03517371 | Completed Results DMC

• 1 other identifier: 1R01HD092444
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

Identifying effective ways to improve function, slow decline and reduce disability is a high priority for people living with Parkinson disease and other chronic conditions. Regular participation in walking is essential to reduce disability and enhance participation in preferred life activities. However, people with chronic conditions are often sedentary, contributing to greater disability. The goal of this work is to determine the benefits of a walking, walking enhancing exercises and cognitive-behavioral strategies delivered using mobile health technology for people with Parkinson disease over a sustained period of time.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Walking; Exercise; Mobile Health; Physical Therapy; Cognitive Behavioral

Outcome Measures

Primary Outcomes (2)

• Walking Activity

  Change in the average number of steps walked per day over the one year study. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Daily steps were averaged at baseline and 12-month and a change score was computed (average of daily steps at 12-Months minus average of daily steps at baseline).

  12 months

• Walking Intensity

  Change in the average number of moderate intensity minutes over the one year study. Moderate intensity minutes is defined as the number of minutes in which \>100 steps were accumulated. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Moderate intensity minutes were averaged at baseline and 12-month and a change score was computed (average of moderate intensity minutes at 12-Months minus average of moderate intensity minutes at baseline).

  12 months

Secondary Outcomes (2)

• Walking Capacity - Six Minute Walk Distance

  12 months

• Walking Capacity - Ten Meter Walk Test

  12 months

Study Arms (2)

mHealth delivered exercise program

EXPERIMENTAL

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.

Other: mHealth delivered exercise program

Exercise only

ACTIVE COMPARATOR

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.

Other: Exercise only

Interventions

mHealth delivered exercise program OTHER

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.

mHealth delivered exercise program

Exercise only OTHER

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.

Exercise only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria;
• Hoehn \& Yahr stages 1-3 (mild to moderate disease severity);
• Stable on all PD medications for at least 2 weeks prior to study entry;
• Willing and able to provide informed consent.

You may not qualify if:

• \< 18 years of age;
• Pregnant;
• diagnosis of atypical Parkinsonism;
• Hoehn \& Yahr stages 4-5
• a score of \> 2 on item 7 of the new freezing of gait questionnaire (moderately or significantly disturbing freezing episodes during daily walking);
• significant cognitive impairment;
• unstable medical or concomitant illnesses or psychiatric conditions, which in the opinion of the investigators would preclude successful participation;
• cardiac problems that interfere with ability to safely exercise
• orthopedic problems in the lower extremities or spine that may limit walking distance;
• unable to walk for 10 continuous minutes independently;
• live in an institution or medical facility (i.e. not in the community)

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Washington University School of Medicine: collaborator

Study Sites (2)

Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University

Boston, Massachusetts, 02215, United States

Location

Washington University St. Louis

St Louis, Missouri, 63108, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Limitations and Caveats

Limitations included slower than expected recruitment levels and higher levels of attrition than projected due to COVID-19 restrictions. To comply with University and Governmental guidelines, in-person visits were put on hold for several months in 2020 and 2021. This prevented collection of secondary outcomes (6-minute and 10 meter walks). However, we were able to continue collection of the primary outcomes (daily steps, moderate intensity minutes) via the step watch remotely.

Results Point of Contact

• Title: Terry Ellis
• Organization: Center for Neurorehabilitation, College of Health & Rehabilitation, Sargent College, Boston University

tellis@bu.edu

617-353-2724

Study Officials

• Theresa D Ellis, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Gammon M Earhart, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors will administer standardizes outcome measures across sites (BU \& WU)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will take place at Boston University (BU) and Washington University in St. Louis (WU). This is a two-arm, single-blinded, 1-year randomized controlled trial. Persons with mild to moderate PD are randomly assigned to one of two treatment arms. In the mHealth arm, individuals participate in a cognitive-behavioral community-based walking program plus home-based walking enhancing progressive resistance exercises delivered using a mobile health platform. The active control condition receives the same components and dose of walking and exercise but without a cognitive-behavioral approach or the use of mobile health technology.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 7, 2018
• Study Start: February 4, 2019
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)