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Идёт набор NCT05799001

Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia

Без фазы С лечением Dementia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dance therapy.
Кому может быть актуально
Состояния в реестре: Dementia. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

It is estimated that the prevalence of dementia in France is 5% for people over 65 years of age and that this increases to 18% for people over 75 years of age. Behavioral disorders are frequent in patients with dementia and are the main cause of institutionalization, representing up to 50% of cases. Dementia syndromes can be translated into behavioral and psychological symptoms of dementia (BPSD), which are defined as perceptual, mood or behavioral disorders. To date, there is no cure for dementia, but certain measures can be taken to reduce symptoms. The HAS suggests that physical exercise would reduce BPSD and could improve the ability to perform activities of daily living or slow down the cognitive decline of this type of patient. Indeed, several articles have highlighted the benefits of physical activity in demented patients. A meta-analysis has shown a significant decrease in BPSD via the Neuropsychiatric Inventory (NPI) score. Nevertheless, it is often observed that there is a difficulty in adhering to the program in very elderly population groups. Dance is a complete physical activity that integrates physical, cognitive and social elements. A meta-analysis has shown that dance has a significant effect on global cognition but also on neuroplasticity and physical functioning in patients with mental disorders. The music component of dance also has an effect on the behavioral problems of demented patients, stimulating language ability and social and emotional function. However, at present, no study of good methodological quality has been able to demonstrate the effectiveness of dance-based physical activity for the treatment of dementia symptoms. As a result of these findings, the APAISE project was developed and should help slow the onset of BPSD in patients with dementia.

Вмешательства

  • Поведенческое Dance therapy
    Patients will be randomized in 2 groups, experimental or control. The experimental group will have 4 months of dance therapy with a professional dancer and will then resume there usual activities. The control group will start with their usual activities in the nursing home for the first 4 months and then, they will have dance sessions with a nurse previously trained by the dancer.

Первичные конечные точки

  • Compare the effectiveness of adding biweekly dance class for 4 months on behavioral and psychological symptoms of dementia in institutionalized older adults compared to usual care alone. [Срок оценки: 4 months]
Вторичные конечные точки (12)
  • evolution of behavioral problems [Срок оценки: - 8 and 12 months for the experimental group- 12 and 16 months for the control group]
  • evaluation of cognitive functions [Срок оценки: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group]
  • autonomy or degree of dependence [Срок оценки: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group]
  • activity frequency of dementia patients [Срок оценки: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group]
  • state of depression [Срок оценки: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group]
  • minimal motor and postural possibilities [Срок оценки: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group]
  • collection of drugs [Срок оценки: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group]
  • program membership [Срок оценки: 12 months for the experimental group16 months for the control group]
  • program membership [Срок оценки: 12 months for the experimental group16 months for the control group]
  • program membership [Срок оценки: 12 months for the experimental group16 months for the control group]
  • contribution of dance-based physical activity for trained caregivers [Срок оценки: 8, 12 and 16 months]
  • contribution of dance-based physical activity for trained caregivers [Срок оценки: 8, 12 and 16 months]

Критерии участия

Критерии включения

  • Institutionalized patient (male or female) over 65 years of age ;
  • Patient with behavioral problems, as measured by an NPI-ES ≥ 4 on any item and an NPI-ES impact scale ≥ 3 ;
  • Patient able to mobilize the upper body at a minimum (arms, trunk, head);
  • Medication (antipsychotics, antidepressants, anxiolytics and related hypnotics) without major modification for at least 30 days prior to inclusion after medical advice;
  • Possibility of including patients under guardianship or curatorship;
  • Patient affiliated to a social security plan;
  • Obtaining consent from the patient or legal representative.

Критерии исключения

  • Inability of the patient to follow the sessions (e.g., major visual/auditory disabilities), difficult follow-up, or any other reason at the discretion of the investigator;
  • Inability of the health care team to complete the NPI-ES questionnaire for the patient;
  • Patient has a concurrent psychiatric disorder (e.g., bipolar disorder, schizophrenia, or other).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Франция · 2 центра
  • Centre Hospitalier Pays Craponne — Craponne-sur-Arzon
  • Centre Hospitalier Emile Roux — Le Puy-en-Velay

Идентификаторы

NCT: NCT05799001 · RIPH2_CHAPPUIS_APAISE · 2022-A02335-38

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗