Examining the Reach, Effectiveness and Maintenance of Social Engagement on Exercise Outcomes: In-home Cycling for Individuals With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Canadian Occupational Performance Measure (COPM) scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Social Cycling Group (Behavioral)
Normal care control
Participants assigned to the normal care control will receive no intervention for the first 6-months then cross over to the cycling intervention.
Biweekly health coach
Following completion of the 6-month cycling intervention, participants will receive a call every 2-weeks to discuss ongoing maintenance efforts.
干预措施: coaching calls (Behavioral)
No health coach
Following the conclusion of the 6-month cycling session, participants will be contacted monthly to record falls. No discussion of ongoing exercise will occur
干预措施: No coaching calls (Behavioral)
结局指标
主要结局
Change in Canadian Occupational Performance Measure (COPM) scores
时间窗: baseline, post-test (~6-months), 3-month follow up (~9-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 averages for each of the top three occupational tasks will be reported.
次要结局
- Change in Pittsburgh Sleep Quality Index(baseline, post-test (~6-months), 3-month follow up (~9-months))
- Change in Timed Up and Go Test(baseline, post-test (~6-months), 3-month follow up (~9-months))
- Change in Four Square Step Test(baseline, post-test (~6-months), 3-month follow up (~9-months))
- Change in Fall Frequency(baseline, post-test (~6-months), 3-month follow up (~9-months))
- Change in Standardized Gait Analysis: Gait Velocity(baseline, post-test (~6-months), 3-month follow up (~9-months))
- Change in Functional Gait Analysis: Gait Velocity(baseline, post-test (~6-months), 3-month follow up (~9-months))
- Change in mini-BESTest Score(baseline, post-test (~6-months), 3-month follow up (~9-months))
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)(baseline, post-test (~6-months), 3-month follow up (~9-months))