Respiratory Sarcopenia in Older Adults

NCT06548984 | Not Yet Recruiting

• 1 other identifier: SarcoResp_Com
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Keywords

Sarcopsarcopenia; geriatrics; respiratory function

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Sociodemografic

  24 months

Study Arms (3)

Experimental group 1

EXPERIMENTAL

diaphragmatic exercises

Other: diaphragmatic exercises

Experimental group 2

EXPERIMENTAL

Respiratory muscle training

Other: Respiratory muscle training

Control group

NO INTERVENTION

No intervention

Interventions

diaphragmatic exercises OTHER

Perform controlled and supervised diaphragmatic exercises

Experimental group 1

Respiratory muscle training OTHER

Perform respiratory muscle training with controlled and supervised devices

Experimental group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Felipe León Morillas: lead

Study Sites (1)

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

Murcia, 30120, Spain

Location

Related Publications (5)

• 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.

  PMID: 31081853 BACKGROUND

• 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.

  PMID: 28095426 BACKGROUND

• 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.

  PMID: 31886813 BACKGROUND

• 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.

  PMID: 33570158 BACKGROUND

• 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.

  PMID: 36673630 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Respiratory Aspiration

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Silvana L de Oliveira Sousa, Dr.

CONTACT

+34868884201; soliveira@um.es

Carmelo S Gómez Martínez, Dr.

CONTACT

csgomez@ucam.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: August 12, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)