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Набор скоро начнётся NCT07388186

Benefits of Strength Training in Informal Caregivers of Patients With Alzheimer's Disease

Без фазы С лечением Frailty Caregiver Burden Anxiety

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: Progressive Muscle Relaxation, Functional Strength Training.
Кому может быть актуально
Состояния в реестре: Frailty, Caregiver Burden, Anxiety. Базовые параметры: от 18 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of a Combined Strength Training and Progressive Muscle Relaxation Program in Reducing Frailty in Informal Caregivers of People With Alzheimer's Disease: A Randomized Controlled Trial

Обзор

Informal caregivers of people with Alzheimer's disease experience high physical and psychological burden, increasing their risk of frailty, anxiety, and caregiver burnout. This randomized controlled trial aims to evaluate the effectiveness of a combined strength training and progressive muscle relaxation program compared with progressive muscle relaxation alone. The intervention will last 10 weeks, with assessments conducted at baseline, post-intervention, and at a 3-month follow-up. Primary outcomes include frailty, anxiety, and caregiver burden.

Подробное описание

Alzheimer's disease is associated with long-term caregiving demands that expose informal caregivers to sustained physical and psychological stress. This chronic exposure may contribute to functional decline, increased vulnerability to frailty, and reduced overall well-being, highlighting the need for accessible, non-pharmacological interventions targeting caregiver health.

The present study adopts a parallel-group randomized controlled design in which participants are allocated to one of two intervention arms. One group will participate in structured progressive muscle relaxation sessions, while the other will receive a combined intervention integrating functional strength training with progressive muscle relaxation. The intervention protocol has been designed to be feasible, low-cost, and easily implementable in community and clinical settings.

Assessments will be conducted at multiple time points to examine changes in physical performance and psychological status over time. Standardized performance-based measures and validated self-report instruments will be used to capture functional and psychosocial outcomes, allowing for a comprehensive evaluation of the intervention effects across short- and medium-term follow-up periods.

Вмешательства

  • Поведенческое Progressive Muscle Relaxation
    Progressive muscle relaxation will be delivered in weekly supervised sessions over a 10-week period. Each session will last approximately 45 minutes and will include diaphragmatic breathing, systematic muscle contraction and relaxation following Jacobson's technique, controlled breathing exercises, and a brief cooldown period. The intervention will be administered by a trained physiotherapist in a group setting.
  • Поведенческое Functional Strength Training
    Functional strength training will be delivered in weekly supervised sessions over a 10-week period. Sessions will last approximately 45 minutes and will focus on improving upper limb, lower limb, and core muscle strength using progressive resistance exercises. Training intensity will be gradually increased according to participant tolerance and performance. All sessions will be supervised by a trained physiotherapist.

Первичные конечные точки

  • Frailty [Срок оценки: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks).]
Вторичные конечные точки (2)
  • Anxiety [Срок оценки: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)]
  • Caregiver burden [Срок оценки: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)]

Критерии участия

Критерии включения

  • Adults aged 18 years or older
  • Informal caregivers of a person with Alzheimer's disease
  • Providing regular care for at least 10 hours per week
  • Ability to attend intervention sessions
  • Ability to understand and follow instructions
  • Provision of written informed consent

Критерии исключения

  • Acute illness or medical conditions contraindicating participation in strength exercise
  • Participation in structured exercise programs that may interfere with study outcomes
  • Severe or uncontrolled psychiatric disorders
  • Physical limitations preventing completion of functional assessments

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Universidad de Salamanca — Salamanca

Идентификаторы

NCT: NCT07388186 · STRENGTH_CAREGIVERS_ALZ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗