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Respiratory Sarcopenia in Older Adults

F

Felipe León Morillas

Status

Not yet enrolling

Conditions

Sarcopenia

Treatments

Other: diaphragmatic exercises
Other: Respiratory muscle training

Study type

Interventional

Funder types

Other

Identifiers

NCT06548984
SarcoResp_Com

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 3 patient groups

Experimental group 1
Experimental group
Description:
diaphragmatic exercises
Treatment:
Other: diaphragmatic exercises
Experimental group 2
Experimental group
Description:
Respiratory muscle training
Treatment:
Other: Respiratory muscle training
Control group
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Central trial contact

Silvana L de Oliveira Sousa, Dr.; Carmelo S Gómez Martínez, Dr.

Data sourced from clinicaltrials.gov

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