In-home Cycling for Individuals With PD: Feasibility

Not Applicable

Completed

Conditions: Parkinson Disease

Interventions: Behavioral: Social Cycling Group

Registration Number: NCT04300023

Lead Sponsor: University of Wisconsin, Madison

Brief 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. It will also 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.

These two studies will examine: 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).

Study 1

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 2

SPECIFIC AIM 1: Determine whether incorporation of social interaction during physical activity significantly improves task adherence and increases task stamina as compared to solo cycling.

* Hypothesis 1a: Those individuals participating in socially engaged cycling will complete a significantly greater number of cycling sessions than individuals in the solo cycling group.

* Hypothesis 1b: Individuals in the social cycling group will cycle for longer durations at each session than solo cyclists, despite the long term goal being 30 minutes per session for both groups.

SPECIFIC AIM 2: Determine whether incorporation of social interaction during physical activity significantly improves activities of daily living, fall rate and quantity of movement for individuals with PD. The primary variables for this aim are Performance Assessment of Self-care Skills Assessment scores, gait velocity and step count.

* Hypothesis 2a: Socially engaged exercise will result in significantly greater improvement in measures of instrumented activities of daily living (IADL; as measured by the Performance Assessment of Self-care Skills (PASS) assessment) as compared to solo cycling.

* Hypothesis 2b: Fall rate will be non-significantly improved with socially engaged cycling but not with solo cycling. Weekly calls will be placed to both groups to record fall rate. Falls data will allow for effect size calculations for future applications.

* Hypothesis 2c: Overall activity level, as measured by an activity monitor, will increase with socially engaged cycling but not with solo cycling.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 13

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Social Cycling Group	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.

Primary Outcome Measures

Name	Time	Method
Adherence: Percentage of Sessions Completed	up to 6 months of active intervention	Total number of completed sessions divided by the prescribed number of sessions per study protocol (72)

Secondary Outcome Measures

Name	Time	Method
Time Per Session	up to 6 months of active intervention	The number of minutes spent cycling during each session
Adverse Events	up to 6 months of active intervention	Adverse events that occur during the active intervention period