Move for Your Mind - Pilot Trial (MFYM - P)
Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia
Move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. The study aims to test the effect of a weekly Dalcroze eurhythmics program (arm 1) and a home strength exercise program (arm 2) against control (no exercise) on the rate of falling, quality of life, gait performance and cognitive function. All groups receive vitamin D. In addition the study shall test the feasibility of the recruitment and the interventions in this target population.
The study includes 60 seniors, age 65 and older, with mild cognitive impairment or mild dementia. Participants are recruited by the memory clinic of City Hospital Waid.
During the 12 months follow-up, participants will have 3 clinical visits (baseline, 6 and 12 month). Despite major efforts the target population is very difficult to recruit and adherence to treatment is low. We therefore decided to stop recruitment and to use this trial as a pilot trial for future clinical trials of the same topic.
研究概览
详细说明
Primary objective To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) will decrease rate of falls in seniors with MCI or mild dementia compared with the control group.
Secondary objectives Objective 1: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases 12-month risk of falling at least once in seniors with MCI or mild dementia compared with the control group.
Objective 2: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves cognitive func-tion and alertness in seniors with MCI or mild dementia compared with the control group.
Objective 3: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases gait variability in seniors with MCI or mild dementia compared with the control group.
Objective 4: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves quality of life in seniors with MCI or mild dementia compared with the control group.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Zurich、瑞士、8037
- Centre on Aging and Mobility, University of Zurich, Waid City Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 65+ years
- Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid
Exclusion Criteria:
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学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Jaques-Dalcroze eurhythmics
Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3
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All participants receive a dose of 800 IU vitamin D3 per day as a standard of care.
800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60.
其他名称：
The Jaques-Dalcroze eurhythmics method includes different courses of motion (multi-task exercises) that are conducted to the rhythm of improvised piano music.
A session starts with a short warm-up that includes simple exercises to get body and mind prepared for the rest of the exercise session.
The complexity of the exercises increases gradually during the session: starting with single tasks and then combining them into a multi-task exercise gradually increasing complexity.
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实验性的：Home exercise program
Home exercise strength program (3x30min/wk) + 800 IU vitamin D
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All participants receive a dose of 800 IU vitamin D3 per day as a standard of care.
800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60.
其他名称：
The home exercise program is a strengthening program that will consist of five simple exercises.
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其他：Vitamin D only
800 IU Vi-De 3
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All participants receive a dose of 800 IU vitamin D3 per day as a standard of care.
800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
大体时间：at month 2, 4, 6, 8, 10 and 12 after baseline
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A fall is defined as unintentional coming to rest on the ground, floor, or other lower level (coming to rest against furniture or a wall is not considered a fall).
All reported incident falls will be ascertained every 2 month (phone calls at 2, 4, 8 and 10 months and clinical visits at 6 and 12 months after baseline) with a questionnaire evaluating the circumstances of each fall and injuries associated with it.
Participants will also receive a diary to record any new health event including a fall.
The diary will serve as a supplementary tool to falls evaluation minimizing potential recall bias.
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at month 2, 4, 6, 8, 10 and 12 after baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Number of participants who fell at least once during 12 months of follow up
大体时间：at month 2, 4, 6, 8, 10 and 12 after baseline
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at month 2, 4, 6, 8, 10 and 12 after baseline
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Gait variability (stride time, stride length and gait speed)
大体时间：Baseline, 6 & 12 months
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assessed by a GAITRite analysis system
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Baseline, 6 & 12 months
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Cognitive function
大体时间：Baseline, 6 & 12 months
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assessed using the Montreal Cognitive Assessment (MoCA)
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Baseline, 6 & 12 months
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Alertness
大体时间：Baseline, 6 & 12 months
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Alertness will be assessed using the two subtests "alertness" and "split alertness" of the test of attentional performance (TAP)
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Baseline, 6 & 12 months
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Quality of life
大体时间：Baseline, 6 and 12 months
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evaluated using the SF-36 questionnaire
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Baseline, 6 and 12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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progression of MCI/mild dementia
大体时间：6 &12 months
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any progression of the cognitive disorder to a more severe state ( will be confirmed based on medical records of the memory clinic of Waid City Hospital.
Evaluation of this endpoint will be supported by information from the MoCA and the TAP subtests at baseline, 6, and 12 months clinical visits.
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6 &12 months
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Musculoskeletal pain
大体时间：baseline, 6 and 12 month
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assessed using McGill pain map.
Number of painful joints will be assessed using a joint map.
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baseline, 6 and 12 month
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合作者和调查者
调查人员
- 首席研究员：Heike Bischoff-Ferrari, Prof.、Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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