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NCT Number: NCT06548984

Respiratory Sarcopenia in Older Adults

The objectives of this study are to describe the prevalence of respiratory sarcopenia, evaluate its pattern of evolution over a one-year follow-up, and determine the response to a therapeutic exercise program in older adults in a geriatric nursing clinic.

A sample of approximately 115 older adults, of both sexes, from the geriatric nursing clinic of the Virgen de la Arrixaca Hospital, Murcia, will participate in the study. In the first stage, a prospective observational study will be carried out, with one year of follow-up, and subsequently a randomized controlled clinical trial, with patients who have been diagnosed with respiratory sarcopenia. In the clinical trial, patients will be divided into 3 groups: control, experimental 1 (diaphragmatic exercises) and experimental 2 (respiratory muscle training). Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory function (respiratory muscle strength and diaphragmatic thickness) and health outcomes (respiratory infections, visit to the emergency department, hospitalization, falls, bedridden and/or death). Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and Kaplan-Meier curves will be used to analyze the data from the longitudinal study. To compare the differences between pre- and post-intervention of the clinical trial, a two-factor analysis of variance for repeated measures will be used. A P-value <0.05 will be considered significant in all analyses. The recording and analysis of the data will be carried out with the IBM SPSS Statistics 24® program.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic Virgen de la Arrixaca Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia

Murcia, 30120, Spain

Location contact

Adriana Catarina De Souxa Oliveira

SUB_INVESTIGATOR

Felipe LEÓN MORILLAS

CONTACT

[email protected]

Silvana Loana De Oliveira Sousa

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • have functional ambulation (even with technical aids)
  • be able to obey simple commands, such as taking deep breaths
  • have sufficient oral occlusion capacity to perform respiratory tes

Exclusion criteria

  • presence of acute respiratory diseases
  • serious orthopedic diseases that interfere with measurements
  • diagnosis of severe dementia
  • those who present any contraindication for performing respiratory pressure measurement tests, as established in the guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR).

Treatment and study plan

diaphragmatic exercises

Other

Perform controlled and supervised diaphragmatic exercises

respiratory muscle training

Other

Perform respiratory muscle training with controlled and supervised devices

Primary outcomes

  1. RESPIRATORY MUSCLE FUNCTION

    Time frame: 24 Months

    INSPIRATORY AND EXPIRATORY PRESSURE OF THE MUSCULATURE

  2. ultrasound

    Time frame: 24 Months

    diaphragm muscle thickness

  3. physical function hand grip

    Time frame: 24 Months

    Hand grip: palm press strength

  4. Physical function

    Time frame: 24 Months

    five times sit-up test (5STS)

  5. Physical function walking speed

    Time frame: 24 Months

    walking speed (4MGS)

  6. body composition

    Time frame: 24 Months

    Calculation of bioimpedance

Secondary outcomes

  1. Sociodemografic

    Time frame: 24 months

    sex, age, marital status and educational level

Study contacts

Contact information is provided by the study sponsor or research team.

Carmelo S Gómez Martínez, Dr.

CONTACT

[email protected]

Silvana L de Oliveira Sousa, Dr.

CONTACT

[email protected]

+34868884201 ext. +34

Sponsors and collaborators

Lead sponsor

Felipe León Morillas

Other

Registry information

Official study title

Respiratory Sarcopenia in Older Adults: Prevalence, Associated Factors and Response to an Exercise Program

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

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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