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临床试验/NCT03545152
NCT03545152已完成不适用

Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment

Tzu-Ting Huang0 个研究点目标入组 192 人开始时间: 2015年8月1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
发起方
入组人数
192
主要终点
Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ)

研究概览

简要总结

This project is proposed to be a three-year project. The purposes of this project are to develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.

详细描述

Aim. develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.

Background. Mild cognitive impairment (MCI) is a common clinical syndrome that identifies people at high risk of developing dementia, and the prevalence range from 7.7 to 51.7%. Although treatments for MCI are currently unavailable, preliminary evidence has identified potential neuro-protective effects of exercise program and cognitive rehabilitation, which may lead to improved outcomes. However, the design and delivery of an appropriate program for people with MCI is challenging for having physical, psychological, cognitive, and social barriers.

Design. A prospective randomized control trial. We developed a Physical activity stage-matched intervention (SMI) (1st year), cognitive rehabilitation (2nd year) and New lifestyle program

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • had a subjective memory complaint
  • MMSE score<16, 21 or 24, based on their years of education (illiterate, 6 or >9 years, respectively, Yeh et al., 2000), but needed >13 or objective memory impairment: AQ>5 or at least one item of IADL dependence
  • able to carry out activities in daily life

排除标准

  • using walking devices
  • depression or dementia diagnosis

研究组 & 干预措施

exercise group

Experimental

The exercise program will include instructions on how to read the program, complete the activities, record their sessions, and exercise safely at first day. To promote incorporating exercising in their daily life routine during the 24-week period, we provided 2 group-based (5-8 participants with 2 instructors at community centers, 60' each) and one home-based (with the exercise program VCD and manual to bring home, 30') exercise program.

干预措施: New life-style (Behavioral)

comparison group

No Intervention

No procedure conducted between the pre- and the post-test evaluations, and they received an abridged version of the training after the post-test session.

exercise group

Experimental

The exercise program will include instructions on how to read the program, complete the activities, record their sessions, and exercise safely at first day. To promote incorporating exercising in their daily life routine during the 24-week period, we provided 2 group-based (5-8 participants with 2 instructors at community centers, 60' each) and one home-based (with the exercise program VCD and manual to bring home, 30') exercise program.

干预措施: Exercise (Behavioral)

cognitive training group

Experimental

Consisted of 12 weekly sessions, lasting 60-90 minutes in groups of 5-8 participants, and 3 monthly boost sessions (to review the strategies and practice solving problems as well). The main strategy was to use cognitive rehabilitation strategies to promote generalization in this process to improve memory and behavior.

干预措施: Cognitive training (Behavioral)

cognitive training group

Experimental

Consisted of 12 weekly sessions, lasting 60-90 minutes in groups of 5-8 participants, and 3 monthly boost sessions (to review the strategies and practice solving problems as well). The main strategy was to use cognitive rehabilitation strategies to promote generalization in this process to improve memory and behavior.

干预措施: New life-style (Behavioral)

结局指标

主要结局

Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ)

时间窗: 5min

There are 11 items and include general memory and prospective memory sections for analysis the type and frequency of memory problem in elders' daily live. Items are posed in likert scale ranges from 1 (never) to 5 (always). The total score may range from 11-55. A higher score indicates a higher level of memory impaired.

Mini-Mental State Examination

时间窗: 8min

The participants' cognitive function was assessed by the Mini-Mental State Examination (cut point base for participants' levels of education).

The Alzheimer's Questionnaire

时间窗: 2min

Malek-Ahmadi et al., (2012) a 21-item, informant-based dementia assessment designed for ease of use in a primary care setting.

次要结局

  • Depressive symptoms(3min)
  • Mobility(10min)
  • Quality of life(8min)

研究者

发起方
Tzu-Ting Huang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tzu-Ting Huang

Professor, School of Nursing

Chang Gung Memorial Hospital

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