Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia

August 15, 2025 updated by: Felipe León Morillas

Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia: Prevalence and Associated Factors

Objectives: The objectives of this study are to describe the prevalence of respiratory sarcopenia in institutionalized older adults. Methodology: A sample of approximately 120 older adults from 5 residences located in Murcia capital will participate in the study. A prospective observational study will be carried out, with one year of follow-up, with patients who have been diagnosed with respiratory sarcopenia. Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory force variables (MIP and PEF) and diaphragmatic ultrasound (thickness, shortening fraction and diaphragmatic excursion) will be measured. Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and KaplanMeier curves will be used to analyze the data from the longitudinal study.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Murcia, Spain
        • Residence of the elderly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Institutionalized elderly diagnosed with respiratory sarcopenia

Description

Inclusion Criteria:

  • To have functional ambulation and/or wheelchair.
  • preserved cognitive status.
  • have sufficient ability to Oral occlusion for carrying out respiratory tests.

Exclusion Criteria:

  • presence of respiratory diseases or in treatment of respiratory diseases.
  • serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia.
  • those who present any contraindication for carrying out the procedure will be excluded.
  • of the respiratory pressure measurement tests, as established in the SEPAR guidelines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Wheelchair

The inclusion criteria to participate in the study are being in a wheelchair, preserved cognitive status and having sufficient ability to Oral occlusion for carrying out respiratory tests. The exclusion criteria are following: presence of respiratory diseases or in treatment of respiratory diseases, serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia. In addition, those who present any contraindication for carrying out the procedure will be excluded.

of the respiratory pressure measurement tests, as established in the SEPAR guidelines. The objectives of the study and the methodology to be used will be explained to all participants.

An information sheet will be provided and the informed consent sheet will be given to them.

wanderers

The inclusion criteria to participate in the study are to have functional ambulation, preserved cognitive status and have sufficient ability to Oral occlusion for carrying out respiratory tests. The exclusion criteria are following: presence of respiratory diseases or in treatment of respiratory diseases, serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia. In addition, those who present any contraindication for carrying out the procedure will be excluded.

of the respiratory pressure measurement tests, as established in the SEPAR guidelines. The objectives of the study and the methodology to be used will be explained to all participants.

An information sheet will be provided and the informed consent sheet will be given to them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic
Time Frame: 8 MONTHS
Sociodemographic dates
8 MONTHS
Clinical variables
Time Frame: 8 MONTHS
Clinical variables will be extracted from history clinic
8 MONTHS
Palm grip strength
Time Frame: 8 MONTHS
Palm grip strength will be measured with the digital hand dynamometer (Jamar©). The Participants will remain seated with the shoulder in 0° adduction; elbow flexed 90° and forearm in neutral position. Three attempts will be made and the best value will be chosen
8 MONTHS
5 SIT TO STAND
Time Frame: 8 MONTHS
The 5STS test measures the time (in seconds) it takes a subject to stop 5 times from a sitting position, as quickly as possible.
8 MONTHS
4 METRES
Time Frame: 8 MONTS
The gait speed test (4MGS) measures the time it takes to cross a line of 4m at normal speed.
8 MONTS
Body composition
Time Frame: 8 MONTHS
- The analysis of body composition will be carried out with the TANITA MC 780-P MA monitor, which provides information on visceral and body fat, skeletal muscle level, BMI and basal metabolism.
8 MONTHS
Respiratoy muscle force
Time Frame: 8 MONTHS
To measure respiratory muscle force, the maximum respiratory pressures will be evaluated in mouth (PIM/PEM). For them we will use an inspiratory and expiratory mouth pressure monitor maximum, a module of the Datapir touch© spirometer (Sibelmed, Barcelona). The measurement will be performed by a previously trained and experienced physiotherapist, following the protocol established by the Spanish Society of Pulmonology (4-SEPAR).
8 MONTHS
Diaphragmatic ultrasound variables
Time Frame: 8 MONTHS
The diaphragmatic ultrasound variables examined will be mobility, thickness and fraction of shortening. For this we will use the Esaote MyLab™ Sigma ultrasound machine (Esaote SpA, Genoa, Italy), with double probe (linear and convex).
8 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health results
Time Frame: 8 MONTHS
The health outcome variables that will be recorded over a year will be: infections respiratory diseases, visit to the emergency department, hospitalization, bedridden and/or death. This Information will be extracted from the patient's clinical record.
8 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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