Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06548984

Respiratory Sarcopenia in Older Adults

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Felipe León Morillas · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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

TypeNameDescription
OTHERdiaphragmatic exercisesPerform controlled and supervised diaphragmatic exercises
OTHERRespiratory muscle trainingPerform respiratory muscle training with controlled and supervised devices

Timeline

Start date
2024-09-01
Primary completion
2024-12-31
Completion
2025-12-31
First posted
2024-08-12
Last updated
2024-08-12

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06548984. Inclusion in this directory is not an endorsement.