Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548984
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-07
Brief Title:
Respiratory Sarcopenia in Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Respiratory Sarcopenia in Older Adults Prevalence Associated Factors and Response to an Exercise Program
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 005 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
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 andor 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 005 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None