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Completed

NCT Number: NCT04300023

In-home Cycling for Individuals With PD: Feasibility

This study will examine the influence of social support on exercise frequency, duration, quality of life, and overall activity level.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Cycling Group

Behavioral

engaged with a research staff member for 30 minutes of cycling

Primary outcomes

  1. 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)

Secondary outcomes

  1. Time Per Session

    Time frame: up to 6 months of active intervention

    The number of minutes spent cycling during each session

  2. Adverse Events

    Time frame: up to 6 months of active intervention

    Adverse events that occur during the active intervention period

Other outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2020
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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