NCT06605183

Brief Summary

The 10,000 Step Club (10KSTC) is a 6-month community walking program for people with Parkinson's disease (PwP) and their caregivers in Las Vegas, Nevada (LV). This program will consist of several weekly, organized walking groups in local parks throughout the LV Valley. Participants in the program will use Nordic walking poles during the walks. Each walking group will meet once per week at a local park and will be supervised by walking group leaders from the University of Nevada, Las Vegas. There will be three walking programs throughout the Las Vegas valley. Participants will be given a step watch to wear step counts will be tracked in real-time. The program is designed to get PwP out of their homes, cultivate a culture of connection with others with Parkinson's disease (PD), and to be collectively accountable for a common goal toward 10,000 steps per day.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2024

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 Start

First participant enrolled

September 11, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

September 12, 2024

Last Update Submit

September 17, 2024

Conditions

Keywords

ExerciseNordic walkingphysical activitysocial isolationlonelinessfear of fallingwalking

Outcome Measures

Primary Outcomes (5)

  • Daily step count average

    Daily step count average over one week as determined using a step watch and using real-time data acquisition software.

    From enrollment to the end of the 6-month community walking program.

  • Fear of Falling Avoidance Behavior

    This will be assessed using the modified Fear of Falling Avoidance Behavior Questionnaire which is a self-report scale ranging from 0 to 56 with higher scores suggestive of more fear of falling avoidance behavior.

    From enrollment to the end of the 6-month community walking program.

  • Social isolation

    Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 - Social Isolation - Short Form 8a. This is a self-report questionnaire ranging from 8 to 40 with higher scores suggestive of more social isolation.

    From enrollment to the end of the 6-month community walking program.

  • Loneliness

    Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 - Loneliness - Fixed Form. This is a self-report questionnaire with scores ranging from 5 to 25 with higher scores suggestive of more loneliness.

    From enrollment to the end of the 6-month community walking program.

  • Self-efficacy

    Patient-Reported Outcomes Measurement Information System (PROMIS) v1.0 - Self-Efficacy for Chronic Conditions - Managing Emotions - Short Form 8a. This is a self-report questionnaire with scores ranging from 8 to 40 with higher scores suggestive of more self-efficacy.

    From enrollment to the end of the 6-month community walking program.

Secondary Outcomes (3)

  • Program goals - feasibility

    Through the completion of the study, an average of 6-months.

  • Program goals - safety

    Through the completion of the study, an average of 6-months.

  • Enrollment goals - diversity

    Through the completion of the study, an average of 6-months.

Study Arms (1)

One hour per week of community walking for 6 months

OTHER

Participants will participate in one, 60-minute group walk using Nordic poles at a local community park. Participants will be assessed before and after the 6-month program.

Behavioral: Community walking program using Nordic walking poles

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 build up their step count to 10,000 steps per day. We do not anticipate that the weekly walk will get them to 10,000 steps but we will use that as a weekly event to drive behavioral change throughout the week.

One hour per week of community walking for 6 months

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 a 6-month study

You may not qualify if:

  • Health diagnosis that would limit exercise participation (e.g., heart problems, uncontrolled blood pressure, exercise-induced asthma).
  • Dementia. 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)

Gait and Balance Laboratory, 217 Bigelow Health Sciences Building, UNLV

Las Vegas, Nevada, 89154, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseMotor ActivitySocial Isolation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehaviorSocial Behavior

Central Study Contacts

Merrill R Landers, 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
Primary investigator

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 20, 2024

Study Start

September 11, 2024

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations