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Respiratory Sarcopenia in Older Adults

NCT06548984 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-12

No results posted yet for this study

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.

Conditions

Interventions

OTHER

diaphragmatic exercises

Perform controlled and supervised diaphragmatic exercises

OTHER

Respiratory muscle training

Perform respiratory muscle training with controlled and supervised devices

Sponsors & Collaborators

  • Felipe León Morillas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06548984 on ClinicalTrials.gov