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Clinical Trials/NCT06548984
NCT06548984Not yet recruitingNot Applicable

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

Felipe León Morillas2 sites in 1 country50 target enrollmentStarted: September 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
RESPIRATORY MUSCLE FUNCTION

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

RESPIRATORY MUSCLE FUNCTION

Time Frame: 24 Months

INSPIRATORY AND EXPIRATORY PRESSURE OF THE MUSCULATURE

physical function hand grip

Time Frame: 24 Months

Hand grip: palm press strength

Physical function walking speed

Time Frame: 24 Months

walking speed (4MGS)

ultrasound

Time Frame: 24 Months

diaphragm muscle thickness

Physical function

Time Frame: 24 Months

five times sit-up test (5STS)

body composition

Time Frame: 24 Months

Calculation of bioimpedance

Secondary Outcomes

  • Sociodemografic(24 months)

Investigators

Sponsor
Felipe León Morillas
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Felipe León Morillas

Investigator

Catholic University of Murcia

Study Sites (2)

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