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Идёт набор NCT07519603

Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program

Без фазы С лечением Chronic Obstructive Pulmonary Disease (COPD) Frailty

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: Vivifrail Exercise program, Usual Care Group.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD), Frailty. 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
Вьетнам
Следующий шаг
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Обзор

Frailty is common among older patients with chronic obstructive pulmonary disease (COPD) and is associated with poor functional outcomes and increased health risks. This study aims to determine the prevalence of frailty and to evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older COPD patients at Hospital 198, Ministry of Public Security, Vietnam.

Подробное описание

Frailty is common among older patients with chronic obstructive pulmonary disease (COPD) and is associated with poor functional outcomes and increased health risks. This study aims to determine the prevalence of frailty and to evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older COPD patients at Hospital 198, Ministry of Public Security, Vietnam.

Frailty is a multidimensional geriatric syndrome characterized by decreased physiological reserve and increased vulnerability to adverse health outcomes. It is highly prevalent among older patients with chronic obstructive pulmonary disease (COPD), contributing to functional decline, increased risk of hospitalization, and mortality.

COPD is a chronic respiratory condition associated with systemic manifestations, including muscle weakness, reduced physical activity, and comorbidities, all of which may accelerate the development of frailty. The coexistence of COPD and frailty leads to worse clinical outcomes and reduced quality of life.

The Vivifrail exercise program is an evidence-based intervention specifically designed to improve physical function and reduce frailty in older adults through individualized exercise training. Previous studies have demonstrated its effectiveness in improving muscle strength, balance, and functional capacity. However, evidence regarding its effectiveness in older COPD patients, particularly in Vietnam, remains limited.

Therefore, this study aims to assess the prevalence of frailty and evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older patients with COPD.

Вмешательства

  • Поведенческое Vivifrail Exercise program
    The Vivifrail exercise program is a structured, multicomponent intervention designed for older adults. It includes individualized exercises focusing on strength, balance, flexibility, and aerobic capacity based on the participant's functional level. The program is performed regularly under supervision or guidance to improve physical performance, reduce frailty, and enhance quality of life
  • Другое Usual Care Group
    Participants receive standard care without structured exercise intervention

Первичные конечные точки

  • Change in Short Physical Performance Battery (SPPB) score [Срок оценки: baseline to 6 months]
Вторичные конечные точки (3)
  • Change in frailty status assessed by Fried frail [Срок оценки: Baseline to 6 months]
  • Change in handgrip strength (kg) [Срок оценки: baseline to 6 months]
  • Change in COPD Assessment Test (CAT) score [Срок оценки: Baseline to 6 months]

Критерии участия

Критерии включения

  • Age ≥ 60 years
  • Diagnosis of COPD according to GOLD criteria
  • Clinically stable COPD (no exacerbation within the past 4 weeks)
  • Able to participate in exercise training
  • Provide informed consent

Критерии исключения

  • Acute COPD exacerbation within the past 4 weeks
  • Severe cardiovascular disease limiting exercise
  • Severe cognitive impairment
  • Musculoskeletal disorders preventing exercise
  • Participation in another clinical trial

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
Открытое
Основная цель
Лечение

Центры проведения

Вьетнам · 2 центра
  • Hospital 198, Ministry of Public Security — Hanoi
  • Hospital 198, Ministry of Public Security — Hanoi

Публикации

  • Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 20 PMID 35150086
  • Azhimamatova R, Salieva RS, Zalova TB, Karimova K, Karimova DS, Dyikanova SA, Kalmatov R, Tynaliev UM. Frailty in COPD: Clinical Impact, Diagnosis, Biomarkers, and Management Strategies. Int J Chron Obstruct Pulmon Dis. 2025 Jul 15;20:2445-2458. doi: 10.2147/COPD.S522862. eCollection 2025. PMID 40688238

Идентификаторы

NCT: NCT07519603 · NGH002198HOS · Vu Thi Diu

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗