Trials / Not Yet Recruiting
Not Yet RecruitingNCT06548984
Respiratory Sarcopenia in Older Adults
Respiratory Sarcopenia in Older Adults: Prevalence, Associated Factors and Response to an Exercise Program
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Felipe León Morillas · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | diaphragmatic exercises | Perform controlled and supervised diaphragmatic exercises |
| OTHER | Respiratory muscle training | Perform respiratory muscle training with controlled and supervised devices |
Timeline
- Start date
- 2024-09-01
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
- First posted
- 2024-08-12
- Last updated
- 2024-08-12
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06548984. Inclusion in this directory is not an endorsement.