Respiratory Sarcopenia in Older Adults

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Other: diaphragmatic exercises; Other: Respiratory muscle training

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvana L de Oliveira Sousa, Dr.; Phone Number: +34 +34868884201; Email: soliveira@um.es
• Study Contact Backup: Name: Carmelo S Gómez Martínez, Dr.; Email: csgomez@ucam.edu

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Hospital Clinic Virgen de la Arrixaca Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia
    • Contact: Felipe LEÓN MORILLAS; Email: fisioleon.jodar@gmail.com
    • Principal Investigator: Silvana Loana De Oliveira Sousa
    • Sub-Investigator: Adriana Catarina De Souxa Oliveira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Experimental: Experimental group 1; diaphragmatic exercises	Other: diaphragmatic exercises; Perform controlled and supervised diaphragmatic exercises
Experimental: Experimental group 2; Respiratory muscle training	Other: Respiratory muscle training; Perform respiratory muscle training with controlled and supervised devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RESPIRATORY MUSCLE FUNCTION	INSPIRATORY AND EXPIRATORY PRESSURE OF THE MUSCULATURE	24 Months
ultrasound	diaphragm muscle thickness	24 Months
physical function hand grip	Hand grip: palm press strength	24 Months
Physical function	five times sit-up test (5STS)	24 Months
Physical function walking speed	walking speed (4MGS)	24 Months
body composition	Calculation of bioimpedance	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemografic	sex, age, marital status and educational level	24 months

Collaborators and Investigators

• Sponsor: Felipe León Morillas

Publications and helpful links

General Publications

• Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017.
• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
• Papadopoulou SK, Tsintavis P, Potsaki P, Papandreou D. Differences in the Prevalence of Sarcopenia in Community-Dwelling, Nursing Home and Hospitalized Individuals. A Systematic Review and Meta-Analysis. J Nutr Health Aging. 2020;24(1):83-90. doi: 10.1007/s12603-019-1267-x.
• Tovar-Alcaraz A, de Oliveira-Sousa SL, Leon-Garzon MC, Gonzalez-Carrillo MJ. [Effects of inspiratory muscle training on respiratory function and balance in stroke survivors: a randomized controlled trial]. Rev Neurol. 2021 Feb 16;72(4):112-120. doi: 10.33588/rn.7204.2020532. Spanish.
• de Oliveira-Sousa SL, Leon-Garzon MC, Gacto-Sanchez M, Ibanez-Vera AJ, Espejo-Antunez L, Leon-Morillas F. Does Inspiratory Muscle Training Affect Static Balance in Soccer Players? A Pilot Randomized Controlled Clinical Trial. Healthcare (Basel). 2023 Jan 14;11(2):262. doi: 10.3390/healthcare11020262.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: geriatrics; respiratory function; Sarcopsarcopenia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: SarcoResp_Com

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No