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| ID | Type | Description | Link |
|---|---|---|---|
| A176000 | Other Identifier | UW Madison | |
| EDUC\KINESIOLOGY\KINESIO | Other Identifier | UW Madison | |
| 1UL1TR002373-01 | U.S. NIH Grant/Contract | View source | |
| 1KL2TR002374-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This study will examine the influence of social support on exercise frequency, duration, quality of life, and overall activity level.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Cycling Group | Behavioral | engaged with a research staff member for 30 minutes of cycling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence: Percentage of Sessions Completed | Total number of completed sessions divided by the prescribed number of sessions per study protocol (72) | up to 6 months of active intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Time Per Session | The number of minutes spent cycling during each session | up to 6 months of active intervention |
| Adverse Events | Adverse events that occur during the active intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Activity Level as Measured by Average Steps Per Day | Participant will wear an activity monitor to collect this data | up to 6 months |
| Change in Canadian Occupational Performance Measure (COPM) Scores |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen A Pickett, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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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All participants who started the solo cycling group crossed over to the social cycling group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Solo Cycling Control Group | Solo Cycling Group: 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] |
| FG001 | Social Cycling Group | 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. Social Cycling Group: engaged with a research staff member for 30 minutes of cycling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before Crossover to Social Group |
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| ||||||||||||||||||
| After Crossover to Social Group |
|
One individual assigned to the social cycling group contracted COVID following the baseline assessment and withdrew prior to starting the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Solo Cycling Control Group | 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] |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence: Percentage of Sessions Completed | Total number of completed sessions divided by the prescribed number of sessions per study protocol (72) | 12 unique participants, 6 solo cycling group crossed over to social group | Posted | Mean | Full Range | percent sessions completed | up to 6 months of active intervention | sessions | sessions |
|
up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Solo Cycling Control Group | 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] |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Pickett, PhD | University of Wisconsin - Madison | (608) 890-2103 | Kristen.pickett@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2019 | Jan 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 24, 2019 | Jan 1, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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12 participants randomly assigned to social cycling group or solo cycling group, solo group participants crossed over to the social group.
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| up to 6 months of active intervention |
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 top three identified occupations will be reported.
| baseline, post-test (~6-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. | baseline, post-test (~6-months) |
| NOT COMPLETED |
|
| Social Cycling Group Only |
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. Social Cycling Group: engaged with a research staff member for 30 minutes of cycling |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. Social Cycling Group: engaged with a research staff member for 30 minutes of cycling |
|
|
| Secondary | Time Per Session | The number of minutes spent cycling during each session | Posted | Mean | Standard Deviation | minutes | up to 6 months of active intervention |
|
|
|
| Secondary | Adverse Events | Adverse events that occur during the active intervention period | Posted | Count of Participants | Participants | up to 6 months of active intervention |
|
|
|
| Other Pre-specified | Overall Activity Level as Measured by Average Steps Per Day | Participant will wear an activity monitor to collect this data | Not Posted | up to 6 months | Participants |
| Other Pre-specified | 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 top three identified occupations will be reported. | Not Posted | baseline, post-test (~6-months) | Participants |
| Other Pre-specified | 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. | Not Posted | baseline, post-test (~6-months) | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Social Cycling Group | 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. Social Cycling Group: engaged with a research staff member for 30 minutes of cycling | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |