Clinical trial NCT06548984: Respiratory Sarcopenia in Older Adults
Official title: Respiratory Sarcopenia in Older Adults: Prevalence, Associated Factors and Response to an Exercise Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopsarcopenia
geriatrics
respiratory function
Lead sponsor: Catholic University of Murcia
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: RESPIRATORY MUSCLE FUNCTION
timeFrame: 24 Months
measure: ultrasound
timeFrame: 24 Months
measure: physical function hand grip
timeFrame: 24 Months
measure: Physical function
timeFrame: 24 Months
measure: Physical function walking speed
timeFrame: 24 Months
measure: body composition
timeFrame: 24 Months
Secondary outcomes:
measure: Sociodemografic
timeFrame: 24 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clinic Virgen de la Arrixaca Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.