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临床试验/NCT05318703
NCT05318703已完成不适用

Virtual Exercise Intervention for Older Adults With MCI

Oregon Research Institute1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年1月20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
69
试验地点
1
主要终点
Change in cognitive functioning assessed by Everyday Cognition

研究概览

简要总结

This project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI).

详细描述

The project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with MCI, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with MCI.

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
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Self-report a change or decline in memory (corroborated by an informant)
  • •Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant)
  • •Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE).

排除标准

  • •Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months,
  • •Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale
  • •Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner
  • •Being unable to follow the consent process or sign the study consent form.

研究组 & 干预措施

cognitively enhanced tai ji quan

Experimental

Participants receive a cognitively enhanced tai ji quan exercise intervention for 16 weeks.

干预措施: tai ji quan (Behavioral)

stretching exercise

Active Comparator

Participants receive a stretching exercise intervention for 16 weeks.

干预措施: Stretching (Behavioral)

结局指标

主要结局

Change in cognitive functioning assessed by Everyday Cognition

时间窗: baseline, 16 weeks

assess change from baseline cognitive functioning at 16 weeks

Change in attention and working memory as assessed by Digit Span - forward and backward

时间窗: baseline, 16 weeks

assess change from baseline in attention and working memory at 16 weeks

Change in dual-task cost as assessed by Timed Up and Go with a cognitive task

时间窗: baseline, 16 weeks

assess change from baseline in the ability to stand up from a chair, walk, and sit down while performing an arithmetic task at 16 weeks

Change in executive function as assessed by Trail Making B

时间窗: baseline, 16 weeks

assess change from baseline executive function at 16 weeks

Change in executive function as assessed by Category Fluency for Animals

时间窗: baseline, 16 weeks

assess change from baseline executive function at 16 weeks

number of dropouts from the intervention and study as assessed by a study recording sheet

时间窗: 16 weeks

assess intervention dropout rate and retention rate

Number of participants expressing intervention program satisfaction as assessed by a self-report survey

时间窗: 16 weeks

assess the program acceptability among tai ji quan participants

Change in global cognitive function assessed by Montreal Cognitive Assessment

时间窗: baseline, 16 weeks

assess change from baseline cognitive function at 16 weeks

Change in balance using a 4-stage balance test

时间窗: baseline, 16 weeks

assess change from baseline in balance at 16 weeks

Change in physical performance as measured by Timed Up and Go test

时间窗: baseline, 16 weeks

assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks

(a) Total number of intervention sessions taught by instructors over the course of study (recorded by a class check sheet) and (b) total number of classes attended by participants over the course of intervention as recorded by class attendance sheet

时间窗: 16 weeks

assess the extent to which interventionists successfully implement the prespecified exercise training protocol.

change in leg strength as assessed by 30-second chair stand test

时间窗: baseline, 16 weeks

assess change from baseline in leg strength at 16 weeks

次要结局

  • Change in quality of life as assessed by EuroQol (EQ-5D-3L)(baseline, 16 weeks)
  • Change in depression as assessed by Geriatric Depression scale(baseline, 16 weeks)
  • Change in physical activity as assessed by International Physical Activity Questionnaire(baseline, 16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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