Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia

NCT06130800 | Completed

• 1 other identifier: SarcoRespi
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Respiratory Function Impaired

Keywords

sarcopenia; respiratory force; institutionalized elderly

Outcome Measures

Primary Outcomes (8)

• Sociodemographic

  Sociodemographic dates

  8 MONTHS

• Clinical variables

  Clinical variables will be extracted from history clinic

  8 MONTHS

• Palm grip strength

  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

  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

  The gait speed test (4MGS) measures the time it takes to cross a line of 4m at normal speed.

  8 MONTS

• Body composition

  \- 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

  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

  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 Outcomes (1)

• Health results

  8 MONTHS

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Institutionalized elderly diagnosed with respiratory sarcopenia

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Felipe León Morillas: lead

Study Sites (1)

Residence of the elderly

Murcia, Spain

Location

MeSH Terms

Conditions

Sarcopenia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 14, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2025
• Last Updated: August 20, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)