Clinical trial NCT04300023: In-home Cycling for Individuals With PD: Feasibility
Official title: Examining the Reach, Effectiveness and Maintenance of Social Engagement on Exercise Outcomes: In-home Cycling for Individuals With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: social support
exercise
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-03-09
Enrollment: 13
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 12 participants randomly assigned to social cycling group or solo cycling group, solo group participants crossed over to the social group.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence: Percentage of Sessions Completed
timeFrame: up to 6 months of active intervention
Secondary outcomes:
measure: Time Per Session
timeFrame: up to 6 months of active intervention
measure: Adverse Events
timeFrame: up to 6 months of active intervention
Other outcomes:
measure: Overall Activity Level as Measured by Average Steps Per Day
timeFrame: up to 6 months
measure: Change in Canadian Occupational Performance Measure (COPM) Scores
timeFrame: baseline, post-test (~6-months)
measure: Change in Fall Frequency
timeFrame: baseline, post-test (~6-months)
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kristen A Pickett, PhD
role: PRINCIPAL_INVESTIGATOR
References: