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临床试验/NCT06130800
NCT06130800已完成不适用

Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia: Prevalence and Associated Factors

Felipe León Morillas2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
127
试验地点
2
主要终点
5 SIT TO STAND

研究概览

简要总结

Objectives: The objectives of this study are to describe the prevalence of respiratory sarcopenia in institutionalized older adults. Methodology: A sample of approximately 120 older adults from 5 residences located in Murcia capital will participate in the study. A prospective observational study will be carried out, with one year of follow-up, with patients who have been diagnosed with respiratory sarcopenia. Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory force variables (MIP and PEF) and diaphragmatic ultrasound (thickness, shortening fraction and diaphragmatic excursion) will be measured. Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and KaplanMeier curves will be used to analyze the data from the longitudinal study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • To have functional ambulation and/or wheelchair.
  • preserved cognitive status.
  • have sufficient ability to Oral occlusion for carrying out respiratory tests.

排除标准

  • presence of respiratory diseases or in treatment of respiratory diseases.
  • serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia.
  • those who present any contraindication for carrying out the procedure will be excluded.
  • of the respiratory pressure measurement tests, as established in the SEPAR guidelines.

结局指标

主要结局

5 SIT TO STAND

时间窗: 8 MONTHS

The 5STS test measures the time (in seconds) it takes a subject to stop 5 times from a sitting position, as quickly as possible.

Clinical variables

时间窗: 8 MONTHS

Clinical variables will be extracted from history clinic

Palm grip strength

时间窗: 8 MONTHS

Palm grip strength will be measured with the digital hand dynamometer (Jamar©). The Participants will remain seated with the shoulder in 0° adduction; elbow flexed 90° and forearm in neutral position. Three attempts will be made and the best value will be chosen

Body composition

时间窗: 8 MONTHS

- The analysis of body composition will be carried out with the TANITA MC 780-P MA monitor, which provides information on visceral and body fat, skeletal muscle level, BMI and basal metabolism.

Diaphragmatic ultrasound variables

时间窗: 8 MONTHS

The diaphragmatic ultrasound variables examined will be mobility, thickness and fraction of shortening. For this we will use the Esaote MyLab™ Sigma ultrasound machine (Esaote SpA, Genoa, Italy), with double probe (linear and convex).

Sociodemographic

时间窗: 8 MONTHS

Sociodemographic dates

4 METRES

时间窗: 8 MONTS

The gait speed test (4MGS) measures the time it takes to cross a line of 4m at normal speed.

Respiratoy muscle force

时间窗: 8 MONTHS

To measure respiratory muscle force, the maximum respiratory pressures will be evaluated in mouth (PIM/PEM). For them we will use an inspiratory and expiratory mouth pressure monitor maximum, a module of the Datapir touch© spirometer (Sibelmed, Barcelona). The measurement will be performed by a previously trained and experienced physiotherapist, following the protocol established by the Spanish Society of Pulmonology (4-SEPAR).

次要结局

  • Health results(8 MONTHS)

研究者

发起方
Felipe León Morillas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Felipe León Morillas

Investigator

Catholic University of Murcia

研究点 (2)

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