In-home Cycling for Individuals With PD: Feasibility
Examining the Reach, Effectiveness and Maintenance of Social Engagement on Exercise Outcomes: In-home Cycling for Individuals With Parkinson Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
engaged with a research staff member for 30 minutes of cycling
|
|
No Intervention: 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]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
up to 6 months of active intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Per Session
Time Frame: up to 6 months of active intervention
|
The number of minutes spent cycling during each session
|
up to 6 months of active intervention
|
|
Adverse Events
Time Frame: up to 6 months of active intervention
|
Adverse events that occur during the active intervention period
|
up to 6 months of active intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fall Frequency
Time Frame: baseline, post-test (~6-months)
|
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)
|
|
Overall Activity Level as Measured by Average Steps Per Day
Time Frame: up to 6 months
|
Participant will wear an activity monitor to collect this data
|
up to 6 months
|
|
Change in Canadian Occupational Performance Measure (COPM) Scores
Time Frame: baseline, post-test (~6-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 top three identified occupations will be reported.
|
baseline, post-test (~6-months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristen A Pickett, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0414: Feasibility
- A176000 (Other Identifier: UW Madison)
- 1UL1TR002373-01 (U.S. NIH Grant/Contract)
- EDUC\KINESIOLOGY\KINESIO (Other Identifier: UW Madison)
- 1KL2TR002374-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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