Walking and mHealth to Increase Participation in Parkinson Disease (WHIPPD)

March 6, 2025 updated by: Theresa D Ellis, Boston University Charles River Campus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Parkinson disease (PD) is one of the most disabling chronic health conditions affecting older adults globally. While advances in medical and surgical management of PD have increased lifespans, these have not effectively altered the progressive decline in physical function and quality of life associated with PD. Identifying effective ways to improve function, slow decline and prevent or reduce disability remains of utmost importance in PD. Of particular concern in PD is gait decline, which is considered a red flag signaling emerging disability. Prior work has shown that people with PD experienced a 12% decline in amount of walking over one year - despite relative stability of motor impairments during that year. Treatment targeting walking, the most rapidly changing aspect of disability in PD, may have the greatest influence on slowing the impact of disease progression on physical function and reducing disability.

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank 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:

  1. < 18 years of age;
  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Activity
Time Frame: 12 months
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
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Capacity - Six Minute Walk Distance
Time Frame: 12 months
Change in the number of meters walked during the six-minute walk test over the one year study. The distance in meters is reported. Participants completed the six-minute walk before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters walked at 12 months minus the number of meters walked at baseline).
12 months
Walking Capacity - Ten Meter Walk Test
Time Frame: 12 months
Change in the number of meters per second walked during the ten-meter walk test (comfortable forward pace) over the one year study. The distance in meters per second are reported. Participants completed the ten-meter walk test before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters per second walked at 12-months minus the number of meters per second walked at baseline).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Collaborators

Washington University School of Medicine

Investigators

  • Principal Investigator: Theresa D Ellis, PhD, Boston University
  • Principal Investigator: Gammon M Earhart, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

March 6, 2024

Study Completion (Actual)

March 6, 2024

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HD092444 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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