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Completed

NCT Number: NCT06130800

Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sociodemographic

    Time frame: 8 MONTHS

    Sociodemographic dates

  2. Clinical variables

    Time frame: 8 MONTHS

    Clinical variables will be extracted from history clinic

  3. 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

  4. 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.

  5. 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.

  6. 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.
  7. 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. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Felipe León Morillas

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Nov 14, 2023
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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