10,000 Step Club: Community Walking Program for People with Parkinson's Disease ((10KSC))

10,000 STEP CLUB: Community Walking Program to Decrease Sedentary Behavior, Fear of Falling Avoidance Behavior, Loneliness, and Social Isolation in Parkinson's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Community walking program using Nordic walking poles

Detailed Description

The 10,000 Step Club (10KSC) is a 6-month community walking program conducted at various local parks in Las Vegas (LV), Nevada for people with Parkinson's disease (PD). There will be three walking groups and each group will meet at a local park once weekly for a 60-minute walk. These walking groups will be led by UNLV physical therapy students who will organize, coordinate, and manage the different walking groups. Participants will be encouraged to attend at least one walking group per week in their area but will be permitted to participate at the other walking groups on different days if they desire to get in a second or third walk that week. Participants in the program will use Nordic walking poles to promote stability and upright posture, and to encourage full body movement and arm use.

There will be three different walking groups throughout Las Vegas in areas with few PD exercise programs and higher proportions of people with Parkinson's disease in lower socioeconomic regions and historically underserved areas. The 10KSC program will be offered in both English and Spanish. Participants will be given a step watch to wear over the 6 months of the program and will be encouraged to build up their physical activity to eventually average 10,000 steps per day. The watches will be used to track step counts in real-time and there will be an incentive program to motivate participants and recognize achievements related to program goals. 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 to decrease social isolation and loneliness, and to be collectively accountable for a common goal toward more physical activity. The 10KSC will be evaluated for effectiveness, feasibility, and safety. The program will target recruitment of 60 participants with Parkinson's disease. Participation will be free of charge and care partners will be encouraged to participate as well. The program inclusion criteria will be "pragmatic" which means that there will be few exclusion criteria and the only inclusion criterion will be a diagnosis of Parkinson's disease by a neurologist.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merrill R Landers, DPT, PhD; Phone Number: 702-895-1377; Email: merrill.landers@unlv.edu

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • Recruiting
      • Gait and Balance Laboratory, 217 Bigelow Health Sciences Building, UNLV
      • Contact: Merrill R Landers, DPT, PhD; Phone Number: 702-895-1377; Email: merrill.landers@unlv.edu

Participation Criteria

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 a 6-month study

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: One hour per week of community walking for 6 months; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program goals - feasibility	Number of participants that started and completed the 6-month program (75% of enrollees will complete the full, 6-month program). Percent week-to-week attendance of the schedule walking days (75% of the participants will have attended at least 75% of the weekly walks (one required per week)). Percent of participants who wear the step watch more than 20 hours per day (75% of the participants will be compliant with wearing the step watch for at least 20 hours per day). Percentage of participants who felt the program was beneficial and worthwhile. (75% of the participants who completed the program will agree or strongly agree that the program was beneficial and worthwhile).	Through the completion of the study, an average of 6-months.
Program goals - safety	Number of falls and other injuries sustained during the weekly walks.; 75% of the participants will have not sustained a fall or injury during participation in the weekly walks.; 75% of the participants will not have sustained a musculoskeletal injury requiring medical attention related to the program.	Through the completion of the study, an average of 6-months.
Enrollment goals - diversity	Participation of Black/African American PwP. 1. Recruitment will be deemed a success if at least 8 participants who identify as Black/African American are recruited and retained. This number is based on the percent of people in LV who identify as Black/African American (12.9%). Participation of Hispanic/Latino/Latina PwP. 1. Recruitment will be deemed a success if at least 20 participants who identify as Hispanic/Latino/Latina are recruited and retained. This number is based on the percent of people in LV who identify as Hispanic/Latino/Latina (33.3%).	Through the completion of the study, an average of 6-months.

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; physical activity; walking; fear of falling; Nordic walking; loneliness; social isolation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: UNLVPT 10KSC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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