Parkinson DiseaseNCT06616948
In-home Cycling for Individuals With PD: Effectiveness
A study testing Social Cycling Group, coaching calls and No coaching calls in people with Parkinson Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study seeks to examine the reach and maintenance of an in-home cycling program for underserved individuals with Parkinson disease and to determine the effectiveness of a 6-month in-home, progressive, tele-exercise cycling program and 3-month health coach follow-up for those same participants. 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, coaching calls and No coaching calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 30 Jun 2024
- 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 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 seeks to examine the reach and maintenance of an in-home cycling program for underserved individuals with Parkinson disease and to determine the effectiveness of a 6-month in-home, progressive, tele-exercise cycling program and 3-month health coach follow-up for those same participants.
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 examines 1) the Reach, Effectiveness, Implementation and Maintenance and 2) the optimal delivery method for an in-home exercise intervention program for individuals with PD living in underserved communities. A managed and meaningful exercise intervention will be delivered that not only addresses the benefits of physical activity for individuals with PD, but also offers a social connection to research staff outside of the participant's typical caregiver(s).
SPECIFIC AIM 1: Examine the reach and maintenance of an in-home cycling program for underserved individuals with PD. Reach will be assessed by examining the demographic characteristics of the individuals enrolled and through the administration of a questionnaire on objective and subjective socioeconomic status to better understand their level of accessibility to services, perceived barriers and economic status. The investigators will also explore the implementation of a health coach to promote effective maintenance of the program after the 6-month intervention. Finally, two interviews will be conducted to better understand strengths and weakness of the program and to better address the needs of the participants in future studies.
- Hypothesis 1a: Demographic characteristics including race and socioeconomic status of the enrolled participants will not statistically differ from the characteristics of the state of WI.
- Hypothesis 1b: Feedback from participant interviews will inform future delivery of the in-home cycling program.
SPECIFIC AIM 2: Determine the effectiveness of a 6-month in-home, progressive, tele-exercise cycling program and 3-month health coach follow-up for underserved populations of individuals with PD.
- Hypothesis 2a: Participants will improve performance of activities of daily living from baseline to posttest. These effects will be maintained at 3-month follow-up.
- Hypothesis 2b: Participants will significantly improve measures of gait and balance performance and non- significantly improve fall rate from baseline to posttest. These effects will be maintained at 3-month follow-up in the group piloting implementation of a health coach, but not in solo follow-up group. Falls data will allow for effect size calculations for future applications.
- Hypothesis 2c: Activity level as measured by an activity monitor will increase from baseline to posttest. This effect will be maintained at 3-month follow-up in health coach group, but not in the solo group.
Study Design: 40 qualified individuals will be paired based on disease severity (score on subsection III of the UPDRS) and age and randomly assigned to either the cycling group or the normal care control group for 6 months. For those in the cycling group, participants will interact via Skype with study team members during all cycling sessions. This intervention will allow the individuals enrolled to participate in regular exercise and a community activity that promotes social support and engagement. The proposed pilot maintenance model for the 3-month period following the intervention will implement a health coach model with scheduled sessions every other week to discuss goals and motivation while decreasing the total contact time with the participant. Individuals in the normal care control group will crossover and complete the cycling intervention following the initial 6 months.
- Conditions
- Parkinson Disease
- Being tested
- Social Cycling Group, coaching calls, No coaching calls
- 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
coaching callsBehavioural
individuals will receive a phone call every 14 days to discuss ongoing exercise maintenance efforts.
No coaching callsBehavioural
Following completion of the 6-month cycling sessions, no maintenance calls will be placed.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| Normal care control | No intervention | Participants assigned to the normal care control will receive no intervention for the first 6-months then cross over to the cycling intervention. |
| Biweekly health coach | Experimental | Following completion of the 6-month cycling intervention, participants will receive a call every 2-weeks to discuss ongoing maintenance efforts. Receives: Behavioral: coaching calls |
| No health coach | Active comparator | Following the conclusion of the 6-month cycling session, participants will be contacted monthly to record falls. No discussion of ongoing exercise will occur Receives: Behavioral: No coaching calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Occupational Performance Measure (COPM) scores
The Canadian Occupational Performance Measure (COPM) will be administered to assess the participant's self-report of performance and satisfaction on a scale of 1 to 10 on self-selected occupational tasks. Performance and satisfaction scores range from 1 (lowest) to 10 (highest) for each identified item. The averages for each of the top three occupational tasks will be reported.
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Secondary outcomes (8)
Change in Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index measures participant quality of sleep in each of 7 domains over the last month: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total possible range of scores is 0-21 with 0 indicating no difficulties and 21 indicating severe difficulties.
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Timed Up and Go Test
The Timed Up and Go Test measures the amount of time (in seconds) that it takes for the participant to stand, walk 3 meters away, and return to the seated position.
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Four Square Step Test
The Four Square Step Test measures the amount of time it takes to step forward, sideways, backward, sideways (and then in the reverse direction back to the start) through the quadrants of a square, stepping over canes that defines its boundaries.
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Fall Frequency
The Fall History Questionnaire is a 6-item survey that asks about Fall rate in the last 2 weeks, last month, last 6 months, the typical cause of a fall, and how the fear of falling may influence daily activities. The hypothesis is that Fall frequency will be improved in the socially engaged cycling group and not with those cycling alone.
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Standardized Gait Analysis: Gait Velocity
A portable electronic walkway, embedded with sensors, will be used to measure spatiotemporal variables including normalized gait velocity. Participants will begin at a starting point two meters from the mat, then walk toward and step onto the mat to continue walking until they achieve the stop line located two meters off of the opposite side of the mat. Data will be collected for forward preferred speed, backward preferred speed, forward fast, tandem and dual task gait. Each participant will complete five trials for each condition or a minimum of 40 steps
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Functional Gait Analysis: Gait Velocity
A portable electronic walkway, embedded with sensors, will be used to measure normalized gait velocity while participants complete a functional shopping task on the instrumented surface.
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in mini-BESTest Score
The mini-BESTest will be used to assess balance. This 14-item, clinical battery is used to assess balance in four component areas (anticipatory transitions, postural response, sensory orientation and dynamic gait) and provides a single number summary of balance performance. Scores range from 0 to 28 with higher scores indicate higher function.
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) assesses disease progress and clinical symptom presentation in four parts: I - Non-motor experience of daily living; II - Motor experience of daily living; III - Motor; and IV Motor complications. Scores range from 0 to 199, with 199 indicating most severe.
Measured: baseline, post-test (~6-months), 3-month follow up (~9-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start25 Aug 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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.
- 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
- The proposed pilot study will utilize the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation and Maintenance) to focus on the reach and effectiveness of a 6-month triweekly in-home cycling program and then pilot a health coach model to promote maintenance for the subsequent 3-month period.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen A Pickett, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616948
- Sponsor's protocol ID
- 2018-0414: Effectiveness
- Other IDs
- A176000, EDUC\KINESIOLOGY\KINESIO
- Status last verified
- Feb 2026
- First submitted
- 25 Sep 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- 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 19 Feb 2026. 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
- NCT06616948
- Acronym / sponsor ID
- 2018-0414: Effectiveness
- Conditions
- Parkinson Disease
- Keywords
- social support, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 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.
This study seeks to examine the reach and maintenance of an in-home cycling program for underserved individuals with Parkinson disease and to determine the effectiveness of a 6-month in-home, progressive, tele-exercise cycling program and 3-month health coach follow-up for those same participants.
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 examines 1) the Reach, Effectiveness, Implementation and Maintenance and 2) the optimal delivery method for an in-home exercise intervention program for individuals with PD living in underserved communities. A managed and meaningful exercise intervention will be delivered that not only addresses the benefits of physical activity for individuals with PD, but also offers a social connection to research staff outside of the participant's typical caregiver(s).
SPECIFIC AIM 1: Examine the reach and maintenance of an in-home cycling program for underserved individuals with PD. Reach will be assessed by examining the demographic characteristics of the individuals enrolled and through the administration of a questionnaire on objective and subjective socioeconomic status to better understand their level of accessibility to services, perceived barriers and economic status. The investigators will also explore the implementation of a health coach to promote effective maintenance of the program after the 6-month intervention. Finally, two interviews will be conducted to better understand strengths and weakness of the program and to better address the needs of the participants in future studies.
- Hypothesis 1a: Demographic characteristics including race and socioeconomic status of the enrolled participants will not statistically differ from the characteristics of the state of WI.
- Hypothesis 1b: Feedback from participant interviews will inform future delivery of the in-home cycling program.
SPECIFIC AIM 2: Determine the effectiveness of a 6-month in-home, progressive, tele-exercise cycling program and 3-month health coach follow-up for underserved populations of individuals with PD.
- Hypothesis 2a: Participants will improve performance of activities of daily living from baseline to posttest. These effects will be maintained at 3-month follow-up.
- Hypothesis 2b: Participants will significantly improve measures of gait and balance performance and non- significantly improve fall rate from baseline to posttest. These effects will be maintained at 3-month follow-up in the group piloting implementation of a health coach, but not in solo follow-up group. Falls data will allow for effect size calculations for future applications.
- Hypothesis 2c: Activity level as measured by an activity monitor will increase from baseline to posttest. This effect will be maintained at 3-month follow-up in health coach group, but not in the solo group.
Study Design: 40 qualified individuals will be paired based on disease severity (score on subsection III of the UPDRS) and age and randomly assigned to either the cycling group or the normal care control group for 6 months. For those in the cycling group, participants will interact via Skype with study team members during all cycling sessions. This intervention will allow the individuals enrolled to participate in regular exercise and a community activity that promotes social support and engagement. The proposed pilot maintenance model for the 3-month period following the intervention will implement a health coach model with scheduled sessions every other week to discuss goals and motivation while decreasing the total contact time with the participant. Individuals in the normal care control group will crossover and complete the cycling intervention following the initial 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The proposed pilot study will utilize the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation and Maintenance) to focus on the reach and effectiveness of a 6-month triweekly in-home cycling program and then pilot a health coach model to promote maintenance for the subsequent 3-month period.
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Normal care control | No intervention | –Participants assigned to the normal care control will receive no intervention for the first 6-months then cross over to the cycling intervention. |
| Biweekly health coach | Experimental | Behavioral: coaching callsFollowing completion of the 6-month cycling intervention, participants will receive a call every 2-weeks to discuss ongoing maintenance efforts. |
| No health coach | Active comparator | Behavioral: No coaching callsFollowing the conclusion of the 6-month cycling session, participants will be contacted monthly to record falls. No discussion of ongoing exercise will occur |
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 |
| coaching callsindividuals will receive a phone call every 14 days to discuss ongoing exercise maintenance efforts. | Behavioural | Biweekly health coach |
| No coaching callsFollowing completion of the 6-month cycling sessions, no maintenance calls will be placed. | Behavioural | No health coach |
Primary outcome
Change in Canadian Occupational Performance Measure (COPM) scores
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
The Canadian Occupational Performance Measure (COPM) will be administered to assess the participant's self-report of performance and satisfaction on a scale of 1 to 10 on self-selected occupational tasks. Performance and satisfaction scores range from 1 (lowest) to 10 (highest) for each identified item. The averages for each of the top three occupational tasks will be reported.
8 secondary outcomes
Change in Pittsburgh Sleep Quality Index
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Timed Up and Go Test
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Four Square Step Test
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Fall Frequency
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Standardized Gait Analysis: Gait Velocity
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in Functional Gait Analysis: Gait Velocity
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Change in mini-BESTest Score
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- 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, coaching calls and No coaching calls 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 19 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Canadian Occupational Performance Measure (COPM) scores (time frame: baseline, post-test (~6-months), 3-month follow up (~9-months)). 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 19 Feb 2026.