Step Up to PD: A Community-based Walking Program for People With Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorSt. Louis University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Community Walking Program
BehavioralThis 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Attend group community walking program for 60 minutes each weekExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety/Rate of Falls - Feasibility
The rate falls related to walking program participation.
Time frame
From enrollment to both the 6 and 12 month endpoints2
Enrollment - Feasibility
The percentage of eligible participants that enroll in the study.
Time frame
Through enrollment of all the study participants3
Attendance - Feasibility
The percentage of attended walking program session across all enrolled participants.
Time frame
Enrollment through the 6- and 12-month endpointsSecondary outcomes
1
Steps per Day
This outcome will be captured via wearable sensors worn through the duration of study participation.
Time frame
From baseline assessment through the the end of the fall reporting period at 18 months2
Balance Discordance
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).
Time frame
From baseline assessment through the 6- and 12-month endpoints3
Loneliness
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.
Time frame
From baseline assessment through the 6- and 12-month endpoints4
Social Connection
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.
Time frame
From baseline assessment through the 6- and 12-month endpointsSponsors and contacts
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Source ClinicalTrials.gov