NCT06859528

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
17mo left

Started Apr 2025

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Apr 2025Sep 2027

First Submitted

Initial submission to the registry

February 27, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

February 27, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

WalkingPhysical ActivitySocial ConnectednessLoneliness

Outcome Measures

Primary Outcomes (3)

  • Safety/Rate of Falls - Feasibility

    The rate falls related to walking program participation.

    From enrollment to both the 6 and 12 month endpoints

  • Enrollment - Feasibility

    The percentage of eligible participants that enroll in the study.

    Through enrollment of all the study participants

  • Attendance - Feasibility

    The percentage of attended walking program session across all enrolled participants.

    Enrollment through the 6- and 12-month endpoints

Secondary Outcomes (4)

  • Steps per Day

    From baseline assessment through the the end of the fall reporting period at 18 months

  • Balance Discordance

    From baseline assessment through the 6- and 12-month endpoints

  • Loneliness

    From baseline assessment through the 6- and 12-month endpoints

  • Social Connection

    From baseline assessment through the 6- and 12-month endpoints

Study Arms (1)

Attend group community walking program for 60 minutes each week

EXPERIMENTAL

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.

Behavioral: Community Walking Program

Interventions

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.

Attend group community walking program for 60 minutes each week

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Health and Movement Science Laboratory, Saint Louis University

St Louis, Missouri, 63104, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Central Study Contacts

Jason K Longhurst, DPT, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations