Walking and mHealth to Increase Participation in Parkinson Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Exercise only; Other: mHealth delivered exercise program

• Registration Number: NCT03517371
• Lead Sponsor: Boston University Charles River Campus

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.

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 Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-05-07
• Study Start: 2019-02-04
• Primary Completion: 2024-03-06
• Study Completion: 2024-03-06
• Status Verified: 2025-03
• Results First Submitted: 2025-03-06
• Results First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Results First Posted: 2025-03-26
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise only	Exercise only	Participants in the control group have up to 10 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.
mHealth delivered exercise program	mHealth delivered exercise program	Participants in the mHealth delivered exercise program have up to 10 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.

Primary Outcome Measures

Name	Time	Method
Walking Activity	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).
Walking Intensity	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).

Secondary Outcome Measures

Name	Time	Method
Walking Capacity - Six Minute Walk Distance	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).
Walking Capacity - Ten Meter Walk Test	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).

Trial Locations

Locations (2)

Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University; 🇺🇸 Boston, Massachusetts, United States

Washington University St. Louis; 🇺🇸 Saint Louis, Missouri, United States