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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Zurich, Швейцария, 8037
- Centre on Aging and Mobility, University of Zurich, Waid City Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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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Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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.
Другие имена:
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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Экспериментальный: 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.
Другие имена:
The home exercise program is a strengthening program that will consist of five simple exercises.
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Другой: 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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of participants who fell at least once during 12 months of follow up
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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progression of MCI/mild dementia
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Heike Bischoff-Ferrari, Prof., Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Нейрокогнитивные расстройства
- Когнитивные расстройства
- Слабоумие
- Когнитивная дисфункция
- Физиологические эффекты лекарств
- Микроэлементы
- Витамины
- Агенты сохранения плотности костей
- Кальций-регулирующие гормоны и агенты
- Витамин Д
- Холекальциферол
Другие идентификационные номера исследования
- SNCTP000000580
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .