- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06859528
Step Up to PD: A Community-based Walking Program for People With Parkinson's Disease
May 12, 2025 updated by: Jason Longhurst, St. Louis University
This study will investigate the feasibility of a 6-month community walking program for people with Parkinson's disease (PD) and their care partners in greater Saint Louis, Missouri region.
The walking program will consist of weekly, organized walking groups at the Missouri Botanical Gardens.
Participants in the program will use Nordic walking poles during the walks.
The walking group(s) will meet once per week and will be supervised by walking group leaders from Saint Louis University.
Participants will be given a smart watch to wear that will help step counts will be tracked in real-time.
The program is designed to get people with Parkinson's disease out of their homes, cultivate a culture of connection with others with Parkinson's disease, and to be collectively accountable for a common goal toward increasing their physical and social engagement in their communities.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
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 Contact
- Name: Jason K Longhurst, DPT, PHD
- Phone Number: 314-977-8533
- Email: jason.longhurst@health.slu.edu
Study Locations
-
-
Missouri
-
St. Louis, Missouri, United States, 63104
- Recruiting
- Integrated Health and Movement Science Laboratory, Saint Louis University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 30-85 years old
- Neurologist-diagnosed Parkinson's disease
- Able to walk independently with or without a walking aid (e.g., cane, walker)
- Willing to participate in study for at least 6 months
Exclusion Criteria:
- Health diagnosis that would limit exercise participation (e.g., heart problems, uncontrolled blood pressure, exercise-induced asthma).
- Additional neurologic disease or injury beyond Parkinson's disease.
- Evidence of significant cognitive impairment. This will be determined by completing the Montreal Cognitive Assessment
- Participants with poor walking ability (determined using the Timed Up and Go Test during initial testing).
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Attend group community walking program for 60 minutes each week
Participants will participate in one, 60-minute group walk using Nordic poles at the Missouri Botanical Gardens for at least 6 months, with an optional continuation upto 12 months.
Participants will be assessed before the program begins, after 6-months, and after 12 months.
Falls will be prospectively collected for 6 months following completion of the program.
|
This is a group, community walking program at local parks using Nordic walking poles.
Participants will be encouraged to walk briskly but safely for 60 minutes one time per week with the ultimate goal of using this community walking program to drive behavioral change (increased physical and social engagement in their communities) throughout the week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment - Feasibility
Time Frame: Through enrollment of all the study participants
|
The percentage of eligible participants that enroll in the study.
|
Through enrollment of all the study participants
|
|
Attendance - Feasibility
Time Frame: Enrollment through the 6- and 12-month endpoints
|
The percentage of attended walking program session across all enrolled participants.
|
Enrollment through the 6- and 12-month endpoints
|
|
Safety/Rate of Falls - Feasibility
Time Frame: From enrollment to both the 6 and 12 month endpoints
|
The rate falls related to walking program participation.
|
From enrollment to both the 6 and 12 month endpoints
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Steps per Day
Time Frame: From baseline assessment through the the end of the fall reporting period at 18 months
|
This outcome will be captured via wearable sensors worn through the duration of study participation.
|
From baseline assessment through the the end of the fall reporting period at 18 months
|
|
Balance Discordance
Time Frame: From baseline assessment through the 6- and 12-month endpoints
|
This is the difference between actual balance confidence (captured via the activities specific balance confidence scale) and predicted balance confidence (modeled from time to complete the Timed Up and Go Test).
|
From baseline assessment through the 6- and 12-month endpoints
|
|
Loneliness
Time Frame: From baseline assessment through the 6- and 12-month endpoints
|
Assessed with the 20 item UCLA loneliness scale in which subjects rate the degree of loneliness that they experience in daily life.
The scale has a minimum score of 20 and maximum score of 80 with higher scores indicating that the individual is experience more loneliness.
|
From baseline assessment through the 6- and 12-month endpoints
|
|
Social Connection
Time Frame: From baseline assessment through the 6- and 12-month endpoints
|
Assessed with the Berkman-Syme Social Network Index, an 11-item questionnaire in which participants rate their perceived social network and isolation.
The index has a minimum score of zero and maximum score of 11 with higher score indicating a larger and stronger social network.
|
From baseline assessment through the 6- and 12-month endpoints
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 1, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
September 30, 2027
Study Registration Dates
First Submitted
February 27, 2025
First Submitted That Met QC Criteria
February 27, 2025
First Posted (Actual)
March 5, 2025
Study Record Updates
Last Update Posted (Actual)
May 14, 2025
Last Update Submitted That Met QC Criteria
May 12, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34235
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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