Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia

Sponsor
Felipe León Morillas (Other)
Overall Status
Recruiting
CT.gov ID
NCT06130800
Collaborator
(none)
50
1
32
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia: Prevalence and Associated Factors
    Actual Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Sociodemographic [8 MONTHS]

      Sociodemographic dates

    2. Clinical variables [8 MONTHS]

      Clinical variables will be extracted from history clinic

    3. Palm grip strength [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 [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 [8 MONTS]

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

    6. Body composition [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 [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 [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 Outcome Measures

    1. Health results [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    -The inclusion criteria to participate in the study are to have functional ambulation and/or wheelchair, preserved cognitive status and have sufficient ability to Oral occlusion for carrying out respiratory tests.

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Residence of the elderly Murcia Spain

    Sponsors and Collaborators

    • Felipe León Morillas

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Felipe León Morillas, Investigator, Catholic University of Murcia
    ClinicalTrials.gov Identifier:
    NCT06130800
    Other Study ID Numbers:
    • SarcoRespi
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Felipe León Morillas, Investigator, Catholic University of Murcia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2023