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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, Madison1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Adherence: Percentage of Sessions Completed

研究概览

简要总结

This study will 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.

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.

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

Solo Cycling Control Group

No Intervention

Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. [will crossover and complete the cycling intervention following the initial 6-months]

Social Cycling Group

Experimental

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)

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 (1)

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