Clinical trial NCT06616948: In-home Cycling for Individuals With PD: Effectiveness
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: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: social support
exercise
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

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: Change in Canadian Occupational Performance Measure (COPM) scores
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Secondary outcomes:
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Timed Up and Go Test
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Four Square Step Test
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Fall Frequency
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Standardized Gait Analysis: Gait Velocity
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Functional Gait Analysis: Gait Velocity
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in mini-BESTest Score
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
Other outcomes:
measure: Change in Free Locomotion Gait Analysis: Time
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Free Locomotion Gait Analysis: Acceleration
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Free Locomotion Gait Analysis: Angular Velocity
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Free Locomotion Gait Analysis: Relative Distance
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-months)
measure: Change in Activity Level Measured by Number of Steps Taken per day
timeFrame: baseline, post-test (~6-months), 3-month follow up (~9-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: