Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06130800
• Other study ID #: SarcoRespi
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Catholic University of Murcia
• Contact: Felipe León Morillas
• Phone: +34605104927
• Email: fisioleon.jodar[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Function Impaired
• Respiratory Insufficiency
• Sarcopenia

Locations

Country	Name	City	State
Spain	Residence of the elderly	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Felipe León Morillas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sociodemographic	Sociodemographic dates	8 MONTHS
Primary	Clinical variables	Clinical variables will be extracted from history clinic	8 MONTHS
Primary	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
Primary	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
Primary	4 METRES	The gait speed test (4MGS) measures the time it takes to cross a line of 4m at normal speed.	8 MONTS
Primary	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
Primary	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
Primary	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	Health results	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