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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
WHIPPD Trial 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.Check my eligibility
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.See study design
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.
WHIPPD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Parkinson's disease as per UK Brain Bank criteria.
Select...
My Parkinson's disease is in the mild to moderate stage.
WHIPPD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Walking Activity
Walking Intensity
Secondary outcome measures
Walking Capacity
WHIPPD 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.
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Who is running the clinical trial?
Boston University Charles River CampusLead Sponsor
113 Previous Clinical Trials
12,017 Total Patients Enrolled
Washington University School of MedicineOTHER
1,931 Previous Clinical Trials
2,299,565 Total Patients Enrolled
Theresa D Ellis, PhDPrincipal Investigator - Boston University
Boston University Charles River Campus
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My Parkinson's disease is in the advanced stages.I have heart issues that prevent me from exercising safely.I have been diagnosed with Parkinson's disease as per UK Brain Bank criteria.My Parkinson's disease medications have been the same for at least 2 weeks.My Parkinson's disease is in the mild to moderate stage.I cannot walk by myself for 10 minutes straight.I have significant difficulty with my memory or thinking.I have been diagnosed with atypical Parkinsonism.I am under 18 years old.I have issues with my legs or back that affect how far I can walk.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise only
- Group 2: mHealth delivered exercise program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of subjects being treated in this research venture?
"Affirmative. Clinical trials.gov reveals that, having initially been posted on February 4th 2019, this research is currently enrolling patients. The study requires 148 individuals from 2 distinct sites to take part in the trial."
Answered by AI
Are there any remaining participant slots for this research endeavor?
"Absolutely. As per the clinicaltrials.gov page, this medical trial is presently recruiting participants for its research project with an initiation date of February 4th 2019 and most recent edit on April 5th 2022. The study requires 148 patients from two centers to be enrolled in it."
Answered by AI
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