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Набор скоро начнётся NCT06548984

Respiratory Sarcopenia in Older Adults

Без фазы С лечением Sarcopenia

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: diaphragmatic exercises, Respiratory muscle training.
Кому может быть актуально
Состояния в реестре: Sarcopenia. Базовые параметры: Без ограничений · 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

Respiratory Sarcopenia in Older Adults: Prevalence, Associated Factors and Response to an Exercise Program

Обзор

The objectives of this study are to describe the prevalence of respiratory sarcopenia, evaluate its pattern of evolution over a one-year follow-up, and determine the response to a therapeutic exercise program in older adults in a geriatric nursing clinic. A sample of approximately 115 older adults, of both sexes, from the geriatric nursing clinic of the Virgen de la Arrixaca Hospital, Murcia, will participate in the study. In the first stage, a prospective observational study will be carried out, with one year of follow-up, and subsequently a randomized controlled clinical trial, with patients who have been diagnosed with respiratory sarcopenia. In the clinical trial, patients will be divided into 3 groups: control, experimental 1 (diaphragmatic exercises) and experimental 2 (respiratory muscle training). Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory function (respiratory muscle strength and diaphragmatic thickness) and health outcomes (respiratory infections, visit to the emergency department, hospitalization, falls, bedridden and/or death). Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and Kaplan-Meier curves will be used to analyze the data from the longitudinal study. To compare the differences between pre- and post-intervention of the clinical trial, a two-factor analysis of variance for repeated measures will be used. A P-value \<0.05 will be considered significant in all analyses. The recording and analysis of the data will be carried out with the IBM SPSS Statistics 24® program.

Вмешательства

  • Другое diaphragmatic exercises
    Perform controlled and supervised diaphragmatic exercises
  • Другое Respiratory muscle training
    Perform respiratory muscle training with controlled and supervised devices

Первичные конечные точки

  • RESPIRATORY MUSCLE FUNCTION [Срок оценки: 24 Months]
  • ultrasound [Срок оценки: 24 Months]
  • physical function hand grip [Срок оценки: 24 Months]
  • Physical function [Срок оценки: 24 Months]
  • Physical function walking speed [Срок оценки: 24 Months]
  • body composition [Срок оценки: 24 Months]
Вторичные конечные точки (1)
  • Sociodemografic [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • have functional ambulation (even with technical aids)
  • be able to obey simple commands, such as taking deep breaths
  • have sufficient oral occlusion capacity to perform respiratory tes

Критерии исключения

  • presence of acute respiratory diseases
  • serious orthopedic diseases that interfere with measurements
  • diagnosis of severe dementia
  • those who present any contraindication for performing respiratory pressure measurement tests, as established in the guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR).

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
Лечение

Центры проведения

Испания · 1 центр
  • Hospital Clinic Virgen de la Arrixaca Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia — Murcia

Публикации

  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48( PMID 31081853
  • Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017. PMID 28095426
  • Papadopoulou SK, Tsintavis P, Potsaki P, Papandreou D. Differences in the Prevalence of Sarcopenia in Community-Dwelling, Nursing Home and Hospitalized Individuals. A Systematic Review and Meta-Analysis. J Nutr Health Aging. 2020;24(1):83-90. doi: 10.1007/s12603-019-1267-x. PMID 31886813
  • Tovar-Alcaraz A, de Oliveira-Sousa SL, Leon-Garzon MC, Gonzalez-Carrillo MJ. [Effects of inspiratory muscle training on respiratory function and balance in stroke survivors: a randomized controlled trial]. Rev Neurol. 2021 Feb 16;72(4):112-120. doi: 10.33588/rn.7204.2020532. Spanish. PMID 33570158
  • de Oliveira-Sousa SL, Leon-Garzon MC, Gacto-Sanchez M, Ibanez-Vera AJ, Espejo-Antunez L, Leon-Morillas F. Does Inspiratory Muscle Training Affect Static Balance in Soccer Players? A Pilot Randomized Controlled Clinical Trial. Healthcare (Basel). 2023 Jan 14;11(2):262. doi: 10.3390/healthcare11020262. PMID 36673630

Идентификаторы

NCT: NCT06548984 · SarcoResp_Com

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗