10,000 Step Club: Community Walking Program for People with Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity of Nevada, Las Vegas
About this trial
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.
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 a 6-month study
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Community walking program using Nordic walking poles
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 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: One hour per week of community walking for 6 monthsOther 1 intervention
Trial outcomes
Primary outcomes
1
Daily step count average
Daily step count average over one week as determined using a step watch and using real-time data acquisition software.
Time frame
From enrollment to the end of the 6-month community walking program.2
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.
Time frame
From enrollment to the end of the 6-month community walking program.3
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.
Time frame
From enrollment to the end of the 6-month community walking program.4
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.
Time frame
From enrollment to the end of the 6-month community walking program.Secondary outcomes
1
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).
Time frame
Through the completion of the study, an average of 6-months.2
Program goals - safety
Number of falls and other injuries sustained during the weekly walks. 1. 75% of the participants will have not sustained a fall or injury during participation in the weekly walks. 2. 75% of the participants will not have sustained a musculoskeletal injury requiring medical attention related to the program.
Time frame
Through the completion of the study, an average of 6-months.3
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%).
Time frame
Through the completion of the study, an average of 6-months.Sponsors and contacts
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Source ClinicalTrials.gov