Parkinson Disease(10KSC)NCT06605183
10,000 Step Club: Community Walking Program for People with Parkinson's Disease
A study testing Community walking program using Nordic walking poles in people with Parkinson Disease, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Community walking program using Nordic walking poles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gait and Balance Laboratory, 217 Bigelow Health Sciences Building, UNLV
Las Vegas, Nevada, 89154
Merrill R Landers, DPT, PhD, 702-895-1377, merrill.landers@unlv.edu
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Community walking program using Nordic walking poles
- Keywords
- Exercise, Nordic walking, physical activity, social isolation, loneliness, fear of falling, walking
- Medical subject headings
- Parkinson Disease, Motor Activity, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community walking program using Nordic walking polesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community walking program using Nordic walking poles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily step count average
Daily step count average over one week as determined using a step watch and using real-time data acquisition software.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the 6-month community walking program.
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
- 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%).
Measured: Through the completion of the study, an average of 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start11 Sep 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merrill Landers, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605183
- Sponsor's protocol ID
- UNLVPT 10KSC
- Acronym
- (10KSC)
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06605183
- Acronym / sponsor ID
- (10KSC) / UNLVPT 10KSC
- Conditions
- Parkinson Disease
- Keywords
- Exercise, Nordic walking, physical activity, social isolation, loneliness, fear of falling, walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One hour per week of community walking for 6 months | Other | Behavioral: Community walking program using Nordic walking polesParticipants 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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community walking program using Nordic walking polesThis 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. | Behavioural | One hour per week of community walking for 6 months |
Primary outcome
Daily step count average
Time frame: From enrollment to the end of the 6-month community walking program.
Daily step count average over one week as determined using a step watch and using real-time data acquisition software.
Fear of Falling Avoidance Behavior
Time frame: From enrollment to the end of the 6-month community walking program.
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.
Social isolation
Time frame: From enrollment to the end of the 6-month community walking program.
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.
Loneliness
Time frame: From enrollment to the end of the 6-month community walking program.
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.
Self-efficacy
Time frame: From enrollment to the end of the 6-month community walking program.
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.
3 secondary outcomes
Program goals - feasibility
Time frame: Through the completion of the study, an average of 6-months.
Program goals - safety
Time frame: Through the completion of the study, an average of 6-months.
Enrollment goals - diversity
Time frame: Through the completion of the study, an average of 6-months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community walking program using Nordic walking poles in people with Parkinson Disease, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merrill R Landers, DPT, PhD (702-895-1377, merrill.landers@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily step count average (time frame: From enrollment to the end of the 6-month community walking program.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.