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临床试验/NCT03624049
NCT03624049已完成不适用

The Impact of Expanding a Community-Based Exercise Program on Social Connectedness and Falls Prevention in Older Adults: Leveraging Exercise to Age in Place (LEAP)

Cedars-Sinai Medical Center18 个研究点 分布在 1 个国家目标入组 671 人开始时间: 2018年6月1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
671
试验地点
18
主要终点
Change in Social Isolation

研究概览

简要总结

The goal of this study is to reduce risk of falls and social isolation in older adults age 50+ through participation in community based health and exercise programs.

详细描述

PRIMARY HYPOTHESES: In community-dwelling ambulatory older adults (age ≥50 years) participation in a community-based group program will improve the Duke Social Support Index (DSSI) score by four points measured after six to eight participation in the program when compared to the DSSI score prior to participation in the program. This increase will be sustained at 26 week follow-up.

SECONDARY HYPOTHESES: Participants in the community-based group exercise activities will have decreased fall risk when measured after six to eight weeks participation in the program when compared to pre-participation as based on responses to the fall risk questionnaire. Cedars-Sinai patients who participate in the community-based programs will have a decrease in health care utilization (as measured by physician visits, Emergency Department visits, and hospitalizations) in the 26 weeks after program enrollment compared to the 26 weeks prior to program enrollment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Must be cognitively stable and must be 50 years or older

排除标准

  • <50 years
  • Cognitive impairment

结局指标

主要结局

Change in Social Isolation

时间窗: Change in Duke Social Support Index from baseline will be measured at 8 weeks and 6 months.

The Duke Social Support Index (DSSI) is an 11 item questionnaire with a total score between 11 and 33 with higher scores indicating increased social connection and lower scores indicating higher social isolation.

次要结局

  • Number of falls with injury in the past 3 months - Reduce Falls(Items will be measured at Baseline, 8 weeks, and 6 months)
  • Number of falls in the past 3 months - Reduce Falls(Items will be measured at Baseline, 8 weeks, and 6 months)
  • Change in Loneliness(Items will be measured at Baseline, 8 weeks, and 6 months; assessing a change in loneliness from baseline to 8 weeks and 6 months)

研究者

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

Allison Mays

Principal Investigator

Cedars-Sinai Medical Center

研究点 (18)

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