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临床试验/NCT04300023
NCT04300023已完成不适用

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

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Adherence: Percentage of Sessions Completed

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

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.

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.

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

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

结局指标

主要结局

Adherence: Percentage of Sessions Completed

时间窗: up to 6 months of active intervention

Total number of completed sessions divided by the prescribed number of sessions per study protocol (72)

次要结局

  • Time Per Session(up to 6 months of active intervention)
  • Adverse Events(up to 6 months of active intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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