Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
研究概览
简要总结
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.
详细描述
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 (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65+ years
- •Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid
排除标准
- 未提供
研究组 & 干预措施
Jaques-Dalcroze eurhythmics
Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3
干预措施: Vi-De 3 (Drug)
Jaques-Dalcroze eurhythmics
Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3
干预措施: Jaques-Dalcroze eurhythmics (Other)
Home exercise program
Home exercise strength program (3x30min/wk) + 800 IU vitamin D
干预措施: Vi-De 3 (Drug)
Home exercise program
Home exercise strength program (3x30min/wk) + 800 IU vitamin D
干预措施: Home exercise program (Other)
Vitamin D only
800 IU Vi-De 3
干预措施: Vi-De 3 (Drug)
结局指标
主要结局
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
时间窗: at month 2, 4, 6, 8, 10 and 12 after baseline
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.
次要结局
- Number of participants who fell at least once during 12 months of follow up(at month 2, 4, 6, 8, 10 and 12 after baseline)
- Gait variability (stride time, stride length and gait speed)(Baseline, 6 & 12 months)
- Cognitive function(Baseline, 6 & 12 months)
- Alertness(Baseline, 6 & 12 months)
- Quality of life(Baseline, 6 and 12 months)