Clinical trial NCT03517371: Walking and mHealth to Increase Participation in Parkinson Disease
Official title: Walking and mHealth to Increase Participation in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
Walking
Exercise
Mobile Health
Physical Therapy
Cognitive Behavioral
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2018-05-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Walking Activity
timeFrame: 12 months
measure: Walking Intensity
timeFrame: 12 months
Secondary outcomes:
measure: Walking Capacity - Six Minute Walk Distance
timeFrame: 12 months
measure: Walking Capacity - Ten Meter Walk Test
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University St. Louis
state: Missouri
Study officials:
affiliation: Boston University
name: Theresa D Ellis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Gammon M Earhart, PhD
role: PRINCIPAL_INVESTIGATOR
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