Parkinson DiseaseNCT04300023
In-home Cycling for Individuals With PD: Feasibility
A study testing Social Cycling Group in people with Parkinson Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will examine the influence of social support on exercise frequency, duration, quality of life, and overall activity level. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Social Cycling Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of idiopathic "definite PD" based upon established criteria
- vision at or corrected to 20/40 or better
- ability to independently ambulate for at least 10 minutes continuously
- no reported vestibular or neurological disease (stroke or muscle disease) beyond their diagnosed PD
- score of greater than or equal to 78 (no evidence of dementia) on the telephone adaptation of the modified mini-mental state exam
- English Speaking
Who cannot join
- contraindication for exercise
- history of muscular or orthopedic diagnosis
- inability to participate in the full duration of the study
- currently exercising for 20 or more minutes per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Reach, Effectiveness and Maintenance of Social Engagement on Exercise Outcomes: In-home Cycling for Individuals With Parkinson Disease
This study will examine the influence of social support on exercise frequency, duration, quality of life, and overall activity level.
Read the detailed description
The benefits of exercise for individuals with Parkinson disease (PD) have been well documented; however, individuals with PD living in rural and underserved urban settings are largely unable or unwilling to participate in group exercise programs due in large part to their distance from such programs and financial considerations. Additionally, community based programs which provide social support and engagement have been shown to benefit elderly individuals as well as individuals with pathology, but are equally unattainable to this group. Taking the exercise to these individuals via telemedicine or tele-exercise may be an ideal means of delivering this type of intervention.
The long-term goal of this project is to improve outcomes for underserved populations of individuals with Parkinson disease (PD) by providing access to in-home physical activity via a telehealth approach. Approximately one million Americans currently live with a diagnosis of PD and it has been estimated that delaying the progression by 20% would result in a $75,891 savings per individual based on reduced health care costs, income maintenance, increased duration of life and improved quality of life. However, individuals with PD of lower socioeconomic status, people of color and rural dwelling seniors have been critically underserved by clinical and academic programming resulting in poorer health outcomes.
This Study will examine the effects of social engagement during in-home exercise on a small sample of individuals with Parkinson Disease (PD). This pilot investigation will directly measure the effect of social support and engagement on exercise outcomes for rural dwelling individuals with PD.
- Conditions
- Parkinson Disease
- Being tested
- Social Cycling Group
- Keywords
- social support, exercise
- 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.
Social Cycling GroupBehavioural
engaged with a research staff member for 30 minutes of cycling
| Study group | Role | What they receive |
|---|---|---|
| Solo Cycling Control Group | No intervention | Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. [will crossover and complete the cycling intervention following the initial 6-months] |
| Social Cycling Group | Experimental | Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present. Receives: Behavioral: Social Cycling Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence: Percentage of Sessions Completed
Total number of completed sessions divided by the prescribed number of sessions per study protocol (72)
Measured: up to 6 months of active intervention
Secondary outcomes (2)
Time Per Session
The number of minutes spent cycling during each session
Measured: up to 6 months of active intervention
Adverse Events
Adverse events that occur during the active intervention period
Measured: up to 6 months of active intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start25 Aug 2021
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- 12 participants randomly assigned to social cycling group or solo cycling group, solo group participants crossed over to the social group.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Kristen A Pickett, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300023
- Sponsor's protocol ID
- 2018-0414: Feasibility
- Other IDs
- A176000, EDUC\KINESIOLOGY\KINESIO, 1UL1TR002373-01, 1KL2TR002374-01
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 2020
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dr. Pickett will be responsible for deciding when/to whom to disseminate coded data, and will work with other researchers if necessary to confirm that they have proper IRB approval/etc., as necessary. Required UW-Madison IRB approval would be obtained prior to the release of any data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Reach, Effectiveness and Maintenance of Social Engagement on Exercise Outcomes: In-home Cycling for Individuals With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04300023
- Acronym / sponsor ID
- 2018-0414: Feasibility
- Conditions
- Parkinson Disease
- Keywords
- social support, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Posted 4 Feb 2025
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 examine the influence of social support on exercise frequency, duration, quality of life, and overall activity level.
Detailed description
The benefits of exercise for individuals with Parkinson disease (PD) have been well documented; however, individuals with PD living in rural and underserved urban settings are largely unable or unwilling to participate in group exercise programs due in large part to their distance from such programs and financial considerations. Additionally, community based programs which provide social support and engagement have been shown to benefit elderly individuals as well as individuals with pathology, but are equally unattainable to this group. Taking the exercise to these individuals via telemedicine or tele-exercise may be an ideal means of delivering this type of intervention.
The long-term goal of this project is to improve outcomes for underserved populations of individuals with Parkinson disease (PD) by providing access to in-home physical activity via a telehealth approach. Approximately one million Americans currently live with a diagnosis of PD and it has been estimated that delaying the progression by 20% would result in a $75,891 savings per individual based on reduced health care costs, income maintenance, increased duration of life and improved quality of life. However, individuals with PD of lower socioeconomic status, people of color and rural dwelling seniors have been critically underserved by clinical and academic programming resulting in poorer health outcomes.
This Study will examine the effects of social engagement during in-home exercise on a small sample of individuals with Parkinson Disease (PD). This pilot investigation will directly measure the effect of social support and engagement on exercise outcomes for rural dwelling individuals with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 12 participants randomly assigned to social cycling group or solo cycling group, solo group participants crossed over to the social group.
| Arm | Type | Receives |
|---|---|---|
| Solo Cycling Control Group | No intervention | –Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. [will crossover and complete the cycling intervention following the initial 6-months] |
| Social Cycling Group | Experimental | Behavioral: Social Cycling GroupExercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of idiopathic "definite PD" based upon established criteria
- vision at or corrected to 20/40 or better
- ability to independently ambulate for at least 10 minutes continuously
- no reported vestibular or neurological disease (stroke or muscle disease) beyond their diagnosed PD
- score of greater than or equal to 78 (no evidence of dementia) on the telephone adaptation of the modified mini-mental state exam
Key exclusion criteria (4 listed)
- contraindication for exercise
- history of muscular or orthopedic diagnosis
- inability to participate in the full duration of the study
- currently exercising for 20 or more minutes per week
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 |
|---|---|---|
| Social Cycling Groupengaged with a research staff member for 30 minutes of cycling | Behavioural | Social Cycling Group |
Primary outcome
Adherence: Percentage of Sessions Completed
Time frame: up to 6 months of active intervention
Total number of completed sessions divided by the prescribed number of sessions per study protocol (72)
2 secondary outcomes
Time Per Session
Time frame: up to 6 months of active intervention
Adverse Events
Time frame: up to 6 months of active intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Dr. Pickett will be responsible for deciding when/to whom to disseminate coded data, and will work with other researchers if necessary to confirm that they have proper IRB approval/etc., as necessary. Required UW-Madison IRB approval would be obtained prior to the release of any data.
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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.
Kristen A Pickett, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cycling Group in people with Parkinson Disease, run by University of Wisconsin, Madison 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 6 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: finished, as of the sponsor's last update on 4 Feb 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?
Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence: Percentage of Sessions Completed (time frame: up to 6 months of active intervention). 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 4 Feb 2025.