跳至主要内容
临床试验/NCT04928885
NCT04928885已完成不适用

Evaluation of the Wits Workout Wellness Program for Older Adults

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2021年7月7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
285
试验地点
2
主要终点
Change in Cognitive Function

研究概览

简要总结

About 11% of the U.S. older adult population is at risk for or suffers from subjective cognitive decline. While some factors such as genetics and habitual physiological changes that affect brain health cannot be changed, research has shown that lifestyle changes such as participation in regular physical activity, staying socially engaged, and managing stress and diet can help to delay or reduce cognitive decline. Yet few brain health promotion programs exist and those that do fail to focus on global health and wellness as a strategy to improve brain health. Wits Workout is a holistic, 12-session, 60-minute per session, multi-modal workshop series that offers adults ages 50 and older facilitated, interactive dialogue and activities about behaviors that promote brain health. Each week includes a different themed module which has four activities and a training component.

详细描述

While research has shown that lifestyle changes such as participation in regular physical activity, staying socially engaged, and managing stress can help to delay or reduce cognitive decline, few cognitive brain health programs exist. Those that do are targeted to a specific audience (i.e., Alzheimer's and related dementias) and primarily focus on one health domain (i.e. physical activity, diet) without the additional focus on multi-dimensions of health, which can also include intellectual engagement, social isolation, stress, sleep, and self-efficacy. Thus, there is a need for a more holistic cognitive health program aimed toward the general older adult population and particularly those that are underserved due to geographic location.

Wits Workout, is a multi-modal 12-session (60 min/week) workshop series designed to enhance brain health among people ages 50 and older. Wits Workout addresses multiple factors that affect cognitive health such as physical activity, diet, intellectual engagement, social isolation, stress, sleep, and self-efficacy. The holistic workshop series is designed to be lay-leader led, interactive, and experiential. Preliminary evaluations demonstrate that this educational series serves a need in reducing isolation, increasing physical activity, promoting intellectual engagement, and enhancing overall brain health in older participants, all of which complement current aging brain health research. The researchers propose to conduct a two-arm randomized controlled trial with a treatment (workshop) group (n=120) and wait-list control group (n=120) who will receive the program after the 6-month study period is completed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • 50 years or older
  • English-speaking and/or able to understand English
  • Have no diagnosis of Alzheimer's or related dementia
  • Score 28 or higher on the TICS cognitive screening
  • Able to participate in the 12 week program
  • Have not previously participated in a Wits Workout program

排除标准

  • Under age 50,
  • Unable to speak or understand English,
  • Have a diagnosis of Alzheimer's or related dementia,
  • Score lower than 28 on TICS
  • Plan to miss more than two weeks of the program (i.e. traveling during that time period)
  • Have previously participated in a Wits Workout program.

结局指标

主要结局

Change in Cognitive Function

时间窗: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline

The PROMIS Cognitive Function measure used to measure cognitive functioning. Raw score is converted into the T-score, with 50 being the mean score. 10 T-score is one standard deviation. Therefore, score above 50 means that a person is better than the average population in mental ability, and lower score meaning worse or disability. The score changing over time can indicate decline in cognitive function (lower score) or improved cognitive function (higher score) or no decline or improvement (same score).

Change in Cognitive Status

时间窗: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline

Telephone Interview for Cognitive Status (TICS). Used to measure cognitive status. For TICS - the minimum = 0 maximum = 50. Higher scores mean better cognition.

次要结局

  • Change in Social Satisfaction(Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline)
  • Self-efficacy(Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline)
  • Change in Sleep(Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline)
  • Change in Physical Activity Levels(Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline)
  • Stress(Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline)

研究者

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

Julie L Bobitt

Assistant Professor

University of Illinois at Chicago

研究点 (2)

Loading locations...

相似试验