Respiratory Sarcopenia in Older Adults: Prevalence, Associated Factors and Response to an Exercise Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- RESPIRATORY MUSCLE FUNCTION
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
RESPIRATORY MUSCLE FUNCTION
Time Frame: 24 Months
INSPIRATORY AND EXPIRATORY PRESSURE OF THE MUSCULATURE
physical function hand grip
Time Frame: 24 Months
Hand grip: palm press strength
Physical function walking speed
Time Frame: 24 Months
walking speed (4MGS)
ultrasound
Time Frame: 24 Months
diaphragm muscle thickness
Physical function
Time Frame: 24 Months
five times sit-up test (5STS)
body composition
Time Frame: 24 Months
Calculation of bioimpedance
Secondary Outcomes
- Sociodemografic(24 months)
Investigators
Felipe León Morillas
Investigator
Catholic University of Murcia
