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临床试验/NCT05247242
NCT05247242已完成不适用

Physical Activity and Social Engagement Program for Persons With Disabilities and Chronic Health Conditions in an Underserved Birmingham Community

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年7月19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
10
试验地点
2
主要终点
Change in Social Isolation from Baseline to 12 weeks

研究概览

简要总结

Using a community-based participatory approach, this project aims to evaluate the feasibility, acceptability, and preliminary efficacy of two technology-driven group activity programs on socioemotional health and physical activity in a local underserved community, Tarrant, Alabama. Participants will complete two six-week programs, specifically Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR).

详细描述

This project will utilize a cross-over randomized design where participants will initially be randomized into either the Online or VR intervention group. After completing the initial six weeks of the assigned intervention, participants will cross over and complete six weeks of the other intervention. No washout period is included due to several reasons, including no known washout period for certain socioemotional outcomes have been established by prior literature, ethical concerns in requiring return to baseline levels during washout, and a prolonged washout period would negatively impact participant adherence and retention to the study. Psychosocial metrics will be collected at the end of each activity session through surveys.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resident of Tarrant, Alabama
  • 18 years or older with a physical disability or chronic health condition or older than 60 years
  • Fluent in English

排除标准

  • Visual impairment that interferes with television viewing

结局指标

主要结局

Change in Social Isolation from Baseline to 12 weeks

时间窗: 12 Weeks

PROMIS Item Bank v2.0 - Social Isolation - SF 8a

次要结局

  • Change in Loneliness from Baseline to 12 weeks(12 Weeks)
  • Change in Physical activity from Baseline to 12 weeks(12 Weeks)
  • Change in Health-related quality of life from Baseline to 12 weeks(12 Weeks)
  • Change in Physical Function from Baseline to 12 weeks(12 Weeks)
  • Change in Positive Affect from Baseline to 12 weeks(12 Weeks)
  • Change in Enjoyment from Baseline to 12 weeks(12 Weeks)
  • Change in Self-efficacy from Baseline to 12 weeks(12 Weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurie A Malone, PhD

Researcher IV

University of Alabama at Birmingham

研究点 (2)

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