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Walking Program + mHealth for Parkinson's Disease (WHIPPD Trial)

N/A

Waitlist Available

Led By Theresa D Ellis, PhD

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria

Hoehn & Yahr stages 1-3 (mild to moderate disease severity)

Must not have

Hoehn & Yahr stages 4-5

Cardiac problems that interfere with ability to safely exercise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the benefits of a walking program, exercises to improve walking, and cognitive-behavioral strategies delivered using mobile health technology for people with Parkinson disease.

Who is the study for?

This trial is for adults with typical Parkinson's disease, stages 1-3, who are stable on medications and can walk independently for at least 10 minutes. It excludes those under 18, pregnant women, people with atypical Parkinsonism or severe freezing during walking, significant cognitive issues, unstable health conditions that could hinder participation, or serious heart or orthopedic problems.

What is being tested?

The study tests the effectiveness of a mobile health (mHealth) delivered exercise program focused on walking and walking enhancement exercises combined with cognitive-behavioral strategies to improve function and reduce disability in people living with Parkinson's disease over time.

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects may include muscle soreness or fatigue from increased physical activity. The mHealth technology itself is unlikely to cause direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's disease as per UK Brain Bank criteria.

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My Parkinson's disease is in the mild to moderate stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My Parkinson's disease is in the advanced stages.

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I have heart issues that prevent me from exercising safely.

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I have significant difficulty with my memory or thinking.

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I have been diagnosed with atypical Parkinsonism.

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I am under 18 years old.

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I cannot walk by myself for 10 minutes straight.

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I have issues with my legs or back that affect how far I can walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Walking Activity

Walking Intensity

Secondary study objectives

Walking Capacity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mHealth delivered exercise programExperimental Treatment1 Intervention

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.

Group II: Exercise onlyActive Control1 Intervention

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.

0 / 9Eligibility criteria met