Clinical trial NCT06605183: 10,000 Step Club: Community Walking Program for People with Parkinson's Disease
Official title: 10,000 STEP CLUB: Community Walking Program to Decrease Sedentary Behavior, Fear of Falling Avoidance Behavior, Loneliness, and Social Isolation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Exercise
Nordic walking
physical activity
social isolation
loneliness
fear of falling
walking
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 30-85 years old
* Neurologist-diagnosed Parkinson\&amp;#39;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).

Primary outcomes:
measure: Daily step count average
timeFrame: From enrollment to the end of the 6-month community walking program.
measure: Fear of Falling Avoidance Behavior
timeFrame: From enrollment to the end of the 6-month community walking program.
measure: Social isolation
timeFrame: From enrollment to the end of the 6-month community walking program.
measure: Loneliness
timeFrame: From enrollment to the end of the 6-month community walking program.
measure: Self-efficacy
timeFrame: From enrollment to the end of the 6-month community walking program.
Secondary outcomes:
measure: Program goals - feasibility
timeFrame: Through the completion of the study, an average of 6-months.
measure: Program goals - safety
timeFrame: Through the completion of the study, an average of 6-months.
measure: Enrollment goals - diversity
timeFrame: Through the completion of the study, an average of 6-months.
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Gait and Balance Laboratory, 217 Bigelow Health Sciences Building, UNLV
state: Nevada
Study officials:
References: