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Набор скоро начнётся NCT06553690

Brain Gym Therapy on Quality of Sleep Among Elderly People

Без фазы С лечением Sleep Disorder Insomnia Cognitive Function Abnormal Old Age; Debility

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: Brain Gym Therapy.
Кому может быть актуально
Состояния в реестре: Sleep Disorder, Insomnia, Cognitive Function Abnormal, Old Age; Debility. Базовые параметры: от 60 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Impact of Brain Gym Therapy on Quality of Sleep Among Elderly People Attending Health Care Facilities

Обзор

This clinical trial aims to evaluate the impact of Brain Gym Therapy on the quality of sleep among elderly individuals attending healthcare facilities. The study will explore whether this non-pharmacological intervention can improve sleep quality, which is often compromised in the elderly population due to various health conditions and age-related changes. Participants will undergo Brain Gym Therapy sessions over a specified period, and their sleep quality will be assessed using validated sleep measurement tools. The findings may provide insights into alternative methods for enhancing sleep in older adults.

Подробное описание

This study investigates the effects of Brain Gym Therapy on the quality of sleep among elderly individuals who are receiving care at healthcare facilities. Brain Gym Therapy, a series of physical activities designed to enhance cognitive functions, has been hypothesized to positively influence sleep patterns by reducing stress, improving relaxation, and enhancing overall mental well-being.

The study will employ a randomized controlled trial design, with participants being randomly assigned to either an intervention group receiving Brain Gym Therapy or a control group receiving standard care without the therapy. The intervention will consist of structured Brain Gym exercises conducted by trained practitioners, focusing on movements that are believed to stimulate brain function and promote relaxation.

Participants will be elderly individuals aged 65 and above, attending healthcare facilities, and experiencing issues with sleep quality. Exclusion criteria will include individuals with severe cognitive impairments, those currently undergoing other sleep interventions, or those with contraindications to physical activity.

The primary outcome measure will be the quality of sleep, assessed using validated sleep questionnaires such as the Pittsburgh Sleep Quality Index (PSQI), alongside secondary outcomes including sleep latency, duration, and efficiency. Data will be collected at baseline, mid-intervention, and post-intervention, with follow-up assessments to determine the sustainability of any observed effects.

The study aims to contribute to the growing body of evidence supporting non-pharmacological interventions for sleep improvement in the elderly, potentially offering a viable alternative to medication for managing sleep disturbances in this population. Ethical approval has been obtained, and all participants will provide informed consent before participation

Вмешательства

  • Другое Brain Gym Therapy
    Brain Gym Therapy is a structured program of physical movements designed to enhance cognitive function, reduce stress, and promote relaxation. The therapy is based on the principle that specific physical activities can stimulate brain function and improve overall mental and physical well-being.

Первичные конечные точки

  • Improvement in Sleep Quality [Срок оценки: Baseline, Week 4 (post-intervention), and Week 8 (follow-up)]

Критерии участия

Критерии включения

Elderly individuals aged 60 years and above. Attending healthcare facilities and able to participate in the study. Experiencing issues with sleep quality, as determined by a score of 5 or higher on the Pittsburgh Sleep Quality Index (PSQI).

Willing and able to provide informed consent. Physically capable of performing gentle physical exercises as part of Brain Gym Therapy

Критерии исключения

Severe cognitive impairment or dementia that would impede understanding or participation in the intervention.

Current participation in another sleep intervention study. Presence of severe medical conditions that contraindicate physical activity (e.g., severe cardiovascular disease, musculoskeletal disorders).

Use of sleep medications that could confound the study results. Recent history (within the past 6 months) of major psychiatric disorders, including severe depression or anxiety.

Any condition that, in the opinion of the investigators, would make participation unsafe or not in the best interest of the participant.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Alanazi MA, Shaban M, Zaky ME. Impact of brain gym therapy on quality of sleep among older adults attending health care facilities. Geriatr Nurs. 2025 Jul-Aug;64:103431. doi: 10.1016/j.gerinurse.2025.103431. Epub 2025 Jun 27. PMID 40580820

Идентификаторы

NCT: NCT06553690 · braingym · HAP-13-S-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗