Respiratory Sarcopenia in Older Adults

NCT ID: NCT06548984

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Experimental group 1

diaphragmatic exercises

Group Type EXPERIMENTAL

diaphragmatic exercises

Intervention Type OTHER

Perform controlled and supervised diaphragmatic exercises

Experimental group 2

Respiratory muscle training

Group Type EXPERIMENTAL

Respiratory muscle training

Intervention Type OTHER

Perform respiratory muscle training with controlled and supervised devices

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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diaphragmatic exercises

Perform controlled and supervised diaphragmatic exercises

Intervention Type OTHER

Respiratory muscle training

Perform respiratory muscle training with controlled and supervised devices

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Felipe León Morillas

OTHER

Sponsor Role lead

Responsible Party

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Felipe León Morillas

Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Murcia, , Spain

Site Status

Countries

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Spain

Central Contacts

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Silvana L de Oliveira Sousa, Dr.

Role: CONTACT

+34868884201 ext. +34

Carmelo S Gómez Martínez, Dr.

Role: CONTACT

Facility Contacts

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Felipe LEÓN MORILLAS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31081853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28095426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31886813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33570158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36673630 (View on PubMed)

Other Identifiers

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SarcoResp_Com

Identifier Type: -

Identifier Source: org_study_id

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