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Идёт набор NCT07392944

Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes (MOVE4CARE)

Без фазы С лечением Frailty 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: Multicomponent exercise intervention, stretching and relaxation program.
Кому может быть актуально
Состояния в реестре: Frailty, 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
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of a Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes: MOVE4CARE

Обзор

Can a multicomponent exercise program significantly improve physical and cognitive function and reduce fall rates among nursing home residents? To address this question, the present study aims to compare the effectiveness of a multicomponent exercise program with a stretching and relaxation program in nursing home residents.

Подробное описание

Individuals residing in nursing homes commonly present with physical frailty and/or cognitive impairment. These geriatric syndromes are strongly associated with accelerated functional and cognitive decline, increased dependency, elevated fall risk, higher rates of hospitalization, and increased mortality. Accordingly, long-term care settings require evidence-based interventions capable of preserving functional capacity and cognitive performance while reducing fall incidence. Non-pharmacological approaches, particularly multicomponent exercise training, have demonstrated beneficial effects on physical and cognitive outcomes in institutionalized older adults. Nevertheless, existing evidence remains limited by methodological heterogeneity, underscoring the need for confirmation through rigorously designed randomized controlled trials. Therefore, this study proposes a 12-week randomized controlled trial in older adults living in nursing homes to evaluate the efficacy of a multicomponent exercise training program incorporating resistance and power, balance, and aerobic components on physical function, cognitive performance, and fall prevention.

The primary objective is to determine whether a multicomponent exercise program produces greater improvements in physical and cognitive function and larger reductions in fall rates compared with a stretching and relaxation program used as an active control. Secondary objectives are to assess whether intervention effects are sustained six weeks following program cessation and to examine the moderating influence of specific subgroups, including frail older adults and individuals with dementia, on intervention-related outcomes.

This study will be conducted as a 12-week assessor-blinded randomized controlled trial with a six-week post-intervention follow-up in nursing homes located in Vila Nova de Gaia, Porto District, Portugal. Participants will be randomly allocated to either a multicomponent exercise training group or an active control group. The intervention group will engage in supervised multicomponent exercise training twice weekly on nonconsecutive days to mitigate fatigue and overtraining. Each session will last 50 to 60 minutes and will comprise a standardized warm-up, progressive resistance and power exercises integrated with aerobic and balance training, followed by a cool-down period consisting of stretching and flexibility exercises. The exercise protocol will be aligned with the Global Consensus on Optimal Exercise recommendations for promoting healthy longevity in older adults. The active control group will participate in stretching, relaxation, and deep-breathing exercises, as well as low-intensity seated physical activities. Outcome assessments will be conducted at baseline, post-intervention at 12 weeks, and at follow-up at 18 weeks, with fall events prospectively monitored on a weekly basis throughout the study period.

Вмешательства

  • Другое Multicomponent exercise intervention
    Twice-weekly for the 12-week duration. The exercise intervention will take place at the nursing homes and consists of 12 weeks of supervised multicomponent exercise training, performed twice weekly on nonconsecutive days to avoid overtraining and fatigue. Each session will last 50-60 min and consist of a warm-up, progressive resistance and power exercises combined with aerobic and balance activities, and a 5-min cool-down period (stretching and flexibility movements). The exercise protocol will
  • Другое stretching and relaxation program
    Twice-weekly for the 12-week duration. The active control Program consist of stretches, deep breathing and relaxation techniques, general (light intensity) physical activity in the sitting position.

Первичные конечные точки

  • Change from Baseline on Short Physical Performance Battery (SPBB) [Срок оценки: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up]
Вторичные конечные точки (6)
  • Change from Baseline on Timed Up and Go (TUG) [Срок оценки: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up]
  • Change from Baseline on Handgrip test [Срок оценки: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up]
  • Falls rate [Срок оценки: Weekly tracking over 18-week study period]
  • Change from baseline in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up]
  • Change from baseline in executive functions as measured by the Trail Making Test (Part A) and Digit Substitution Symbol Test [Срок оценки: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up]
  • Change from baseline in mood as measured by the Geriatric Depression Scale [Срок оценки: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up]

Критерии участия

Критерии включения

  • Ability to ambulate (with or without assistance);
  • Ability to perform chair stands (with or without assistance);
  • Ability to understand and properly follow testing procedures.

Критерии исключения

  • Any contraindication that precludes exercise performance or testing procedures, including terminal illness, uncontrolled disease, or other unstable medical conditions;
  • Short Physical Performance Battery (SPPB) score < 3 points;
  • Participation in any exercise intervention within the past 3 months;
  • Simultaneous participation in another clinical trial during the study;
  • Planned transfer to another nursing home facility, to home, or to hospitalization during the intervention.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Португалия · 1 центр
  • Faculty of Sports, University of Porto — Porto

Идентификаторы

NCT: NCT07392944 · CEFADE322025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗