Respiratory Sarcopenia in Older Adults

Not Applicable

Not yet recruiting

• Conditions: Sarcopenia
• Interventions: Other: diaphragmatic exercises; Other: Respiratory muscle training

• Registration Number: NCT06548984
• Lead Sponsor: Felipe León Morillas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-07
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Study Start: 2024-09-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 1	diaphragmatic exercises	diaphragmatic exercises
Experimental group 2	Respiratory muscle training	Respiratory muscle training

Primary Outcome Measures

Name	Time	Method
RESPIRATORY MUSCLE FUNCTION	24 Months	INSPIRATORY AND EXPIRATORY PRESSURE OF THE MUSCULATURE
physical function hand grip	24 Months	Hand grip: palm press strength
Physical function walking speed	24 Months	walking speed (4MGS)
ultrasound	24 Months	diaphragm muscle thickness
Physical function	24 Months	five times sit-up test (5STS)
body composition	24 Months	Calculation of bioimpedance

Secondary Outcome Measures

Name	Time	Method
Sociodemografic	24 months	sex, age, marital status and educational level

Trial Locations

Locations (1)

Hospital Clinic Virgen de la Arrixaca Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia; 🇪🇸 Murcia, Spain