Parkinson DiseaseNCT06859528
Step Up to PD: A Community-based Walking Program for People With Parkinson's Disease
A study testing Community Walking Program in people with Parkinson Disease and Parkinson Disease, Idiopathic, run by St. Louis University at 1 site in United States.
Trial summary
This study will investigate the feasibility of a 6-month community walking program for people with Parkinson's disease (PD) and their care partners in greater Saint Louis, Missouri region. The walking program will consist of weekly, organized walking groups at the Missouri Botanical Gardens. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease, Parkinson Disease, Idiopathic
- What is being tested?
- Community Walking Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 study for at least 6 months
Who cannot join
- Health diagnosis that would limit exercise participation (e.g., heart problems, uncontrolled blood pressure, exercise-induced asthma).
- Additional neurologic disease or injury beyond Parkinson's disease.
- Evidence of significant cognitive impairment. 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Integrated Health and Movement Science Laboratory, Saint Louis University
St Louis, Missouri, 63104
About this study
This study will investigate the feasibility of a 6-month community walking program for people with Parkinson's disease (PD) and their care partners in greater Saint Louis, Missouri region. The walking program will consist of weekly, organized walking groups at the Missouri Botanical Gardens. Participants in the program will use Nordic walking poles during the walks. The walking group(s) will meet once per week and will be supervised by walking group leaders from Saint Louis University. Participants will be given a smart watch to wear that will help step counts will be tracked in real-time. 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, and to be collectively accountable for a common goal toward increasing their physical and social engagement in their communities.
- Conditions
- Parkinson Disease, Parkinson Disease, Idiopathic
- Being tested
- Community Walking Program
- Keywords
- Walking, Physical Activity, Social Connectedness, Loneliness
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Walking ProgramBehavioural
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 drive behavioral change (increased physical and social engagement in their communities) throughout the week.
| Study group | Role | What they receive |
|---|---|---|
| Attend group community walking program for 60 minutes each week | Experimental | Participants will participate in one, 60-minute group walk using Nordic poles at the Missouri Botanical Gardens for at least 6 months, with an optional continuation upto 12 months. Participants will be assessed before the program begins, after 6-months, and after 12 months. Falls will be prospectively collected for 6 months following completion of the program. Receives: Behavioral: Community Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Rate of Falls - Feasibility
The rate falls related to walking program participation.
Measured: From enrollment to both the 6 and 12 month endpoints
Enrollment - Feasibility
The percentage of eligible participants that enroll in the study.
Measured: Through enrollment of all the study participants
Attendance - Feasibility
The percentage of attended walking program session across all enrolled participants.
Measured: Enrollment through the 6- and 12-month endpoints
Secondary outcomes (4)
Steps per Day
This outcome will be captured via wearable sensors worn through the duration of study participation.
Measured: From baseline assessment through the the end of the fall reporting period at 18 months
Balance Discordance
This is the difference between actual balance confidence (captured via the activities specific balance confidence scale) and predicted balance confidence (modeled from time to complete the Timed Up and Go Test).
Measured: From baseline assessment through the 6- and 12-month endpoints
Loneliness
Assessed with the 20 item UCLA loneliness scale in which subjects rate the degree of loneliness that they experience in daily life. The scale has a minimum score of 20 and maximum score of 80 with higher scores indicating that the individual is experience more loneliness.
Measured: From baseline assessment through the 6- and 12-month endpoints
Social Connection
Assessed with the Berkman-Syme Social Network Index, an 11-item questionnaire in which participants rate their perceived social network and isolation. The index has a minimum score of zero and maximum score of 11 with higher score indicating a larger and stronger social network.
Measured: From baseline assessment through the 6- and 12-month endpoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Longhurst, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859528
- Sponsor's protocol ID
- 34235
- Status last verified
- May 2025
- First submitted
- 27 Feb 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Up to PD: A Community-based Walking Program for People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06859528
- Acronym / sponsor ID
- 34235
- Conditions
- Parkinson Disease, Parkinson Disease, Idiopathic
- Keywords
- Walking, Physical Activity, Social Connectedness, Loneliness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Mar 2025 (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.
This study will investigate the feasibility of a 6-month community walking program for people with Parkinson's disease (PD) and their care partners in greater Saint Louis, Missouri region. The walking program will consist of weekly, organized walking groups at the Missouri Botanical Gardens. Participants in the program will use Nordic walking poles during the walks. The walking group(s) will meet once per week and will be supervised by walking group leaders from Saint Louis University. Participants will be given a smart watch to wear that will help step counts will be tracked in real-time. 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, and to be collectively accountable for a common goal toward increasing their physical and social engagement in their communities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attend group community walking program for 60 minutes each week | Experimental | Behavioral: Community Walking ProgramParticipants will participate in one, 60-minute group walk using Nordic poles at the Missouri Botanical Gardens for at least 6 months, with an optional continuation upto 12 months. Participants will be assessed before the program begins, after 6-months, and after 12 months. Falls will be prospectively collected for 6 months following completion of the 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 study for at least 6 months
Key exclusion criteria (4 listed)
- Health diagnosis that would limit exercise participation (e.g., heart problems, uncontrolled blood pressure, exercise-induced asthma).
- Additional neurologic disease or injury beyond Parkinson's disease.
- Evidence of significant cognitive impairment. 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 ProgramThis 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 drive behavioral change (increased physical and social engagement in their communities) throughout the week. | Behavioural | Attend group community walking program for 60 minutes each week |
Primary outcome
Safety/Rate of Falls - Feasibility
Time frame: From enrollment to both the 6 and 12 month endpoints
The rate falls related to walking program participation.
Enrollment - Feasibility
Time frame: Through enrollment of all the study participants
The percentage of eligible participants that enroll in the study.
Attendance - Feasibility
Time frame: Enrollment through the 6- and 12-month endpoints
The percentage of attended walking program session across all enrolled participants.
4 secondary outcomes
Steps per Day
Time frame: From baseline assessment through the the end of the fall reporting period at 18 months
Balance Discordance
Time frame: From baseline assessment through the 6- and 12-month endpoints
Loneliness
Time frame: From baseline assessment through the 6- and 12-month endpoints
Social Connection
Time frame: From baseline assessment through the 6- and 12-month endpoints
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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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.
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 in people with Parkinson Disease and Parkinson Disease, Idiopathic, run by St. Louis University 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 4 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason K Longhurst, DPT, PHD (314-977-8533, jason.longhurst@health.slu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Rate of Falls - Feasibility (time frame: From enrollment to both the 6 and 12 month endpoints). The study lists 3 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 14 May 2025.