In-home Cycling for Individuals With PD: Feasibility

Study Overview
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Brief Summary
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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
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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.

Official Title
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Examining the Reach, Effectiveness and Maintenance of Social Engagement on Exercise Outcomes: In-home Cycling for Individuals With Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Social Cycling Group
* Behavioral: Solo Cycling Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This pilot study will utilize two separate experimental designs Study 1: 40 participants randomly assigned to cycling group or a waitlist normal care control group, normal care control group will get cycling intervention after 6 months Study 2: 12 participants randomly assigned to social cycling group or solo cycling group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Study 1: Normal Care Control Group<br>Study 1: Normal Care Control Group [will crossover and complete the cycling intervention following the initial 6-months] | |
| Experimental: Study 1: Social Cycling Group<br>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. | Behavioral: Social Cycling Group<br>* engaged with a research staff member for 30 minutes of cycling<br>|
| Experimental: Study 2: Social Cycling Group<br>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. | Behavioral: Social Cycling Group<br>* engaged with a research staff member for 30 minutes of cycling<br>|
| Experimental: Study 2: Solo Cycling Group<br>Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to cycling without a partner for a target duration and intensity. | Behavioral: Solo Cycling Group<br>* Exercise without a partner for a target period of time and intensity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Standardized Gait Analysis: Gait Velocity | A portable electronic walkway, embedded with sensors, will be used to measure spatiotemporal variables including normalized gait velocity. Participants will begin at a starting point two meters from the mat, then walk toward and step onto the mat to continue walking until they achieve the stop line located two meters off of the opposite side of the mat. Data will be collected for forward preferred speed, backward preferred speed, forward fast, tandem and dual task gait. Each participant will complete five trials for each condition or a minimum of 40 steps | baseline, post-test ( 6-months), 3-month follow up ( 9-months) | 
| Change in Functional Gait Analysis: Gait Velocity | A portable electronic walkway, embedded with sensors, will be used to measure normalized gait velocity while participants complete a functional shopping task on the instrumented surface. | baseline, post-test ( 6-months), 3-month follow up ( 9-months) | 
| 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. | baseline, post-test ( 6-months), 3-month follow up ( 9-months) | 
| Change in mini-BESTest Score | The mini-BESTest will be used to assess balance. This 14-item, clinical battery is used to assess balance in four component areas (anticipatory transitions, postural response, sensory orientation and dynamic gait) and provides a single number summary of balance performance. Scores range from 0 to 28 with higher scores indicate higher function. | baseline, post-test ( 6-months), 3-month follow up ( 9-months) | 
| Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) assesses disease progress and clinical symptom presentation in four parts: I - Non-motor experience of daily living; II - Motor experience of daily living; III - Motor; and IV Motor complications. Scores range from 0 to 199, with 199 indicating most severe. | baseline, post-test ( 6-months), 3-month follow up ( 9-months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index measures participant quality of sleep in each of 7 domains over the last month: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total possible range of scores is 0-21 with 0 indicating no difficulties and 21 indicating severe difficulties. | baseline, post-test ( 6-months), 3-month follow up ( 9-months) | 
| Change in Timed Up and Go Test | The Timed Up and Go Test measures the amount of time (in seconds) that it takes for the participant to stand, walk 3 meters away, and return to the seated position. | baseline, post-test ( 6-months), 3-month follow up ( 9-months) | 
| Change in Activity Level Measured by Number of Steps Taken per day | The hypothesis is that 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. | baseline, post-test ( 6-months), 3-month follow up ( 9-months) | 
| Change in Four Square Step Test | The Four Square Step Test measures the amount of time it takes to step forward, sideways, backward, sideways (and then in the reverse direction back to the start) through the quadrants of a square, stepping over canes that defines its boundaries. | baseline, post-test ( 6-months), 3-month follow up ( 9-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), 3-month follow up ( 9-months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social support, exercise