Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607718
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Nutritional and Exercise Intervention in Older Adults Admitted to the Acute Care Unit SERIA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hyperproteic Oral Supplementation With Vitamin D and Resistance Training in Older Patients Admitted to the Acute Unit SERIA
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SERIA
Brief Summary:
This is a randomised parallel single-blind clinical trial Objectives to evaluate the impact of the intervention on nutritional status body composition strength the prevalence of sarcopenia and physical performance at discharge and three months later
Detailed Description:
Design A randomised controlled clinical trial with four parallel groups is being conducted with older adults admitted to an acute geriatric unit at risk of malnutrition or with malnutrition The participants are randomly assigned to one of the groups Three assessment visits are being conducted at admission discharge and three months later
Setting The study is being conducted in the Unidad de Agudos del Servicio de Geriatría at Hospital Universitario Ramón y Cajal by the Servicio Madrileño de Salud SERMAS
Interventions four groups 1 a resistance training group RT 2 an oral nutritional supplementation group ONS 3 a combination of RT and ONS RTONS and a control group CG The patients in the RT group follow individualized RT sessions with a physiotherapist daily during the hospitalization and three weekly home sessions on their own after discharge The sessions are structured according to the recommendations of the American College of Sports Medicine ACSM mainly RT
Study population A study of malnourished or at-risk outpatients in our setting was used to calculate the sample size In that study with an alpha error of 005 and a beta of 080 the minimum sample size was 14 participants per group Our objective is to include at least 21 participants per group resulting in a total of 84 participants
Sociodemographic and clinical variables are being collected eg age sex living situation number of drugs falls Information about nutritional and functional status eg MNA gait speed Barthel Lawton and FAC body composition eg weight height body mass index appendicular muscle mass index measured by bioimpedanciometry BIA ultrasound measurements of the anterior rectus area thickness and penation angle and muscle strength hand grip test is also collected
The first descriptive analysis of the variables will include frequencies and percentages for categorical variables and means and standard deviations for continuous variables Changes in nutritional status will be analysed as well as the interaction between nutrition and exercise by repeated measures ANOVA The prevalence of sarcopenia and the influence of each component of the sarcopenia definition on physical performance ADLs emergency room visits and new admissions Additionally a survival analysis will be performed to compare the four groups To assess the quality of ultrasound measurement the relationship between each ultrasound variable and the bioimpedance score as well as the diagnostic criteria for malnutrition and sarcopenia will be analysed Furthermore ultrasound measurements will be correlated with the estimation of muscle mass using bioimpedance analysis A p-value less than 005 will be considered statistically significant
The study is being conducted under the ethical standards set forth by the Comité de Ética de Investigación con Medicamentos CEIm of the Hospital Universitario Ramón y Cajal Each participant is informed about the study and signs the informed consent before inclusion The study has been designed and subsequently evaluated under Law 142007 on Biomedical Research the ethical principles of the Declaration of Helsinki of the World Medical Association on Ethical Principles for Medical Research on Human Beings as well as the other ethical principles and legal regulations applicable according to the characteristics of the study
Setting The study is being conducted in the Unidad de Agudos del Servicio de Geriatría at Hospital Universitario Ramón y Cajal by the Servicio Madrileño de Salud SERMAS
Interventions four groups 1 a resistance training group RT 2 an oral nutritional supplementation group ONS 3 a combination of RT and ONS RTONS and a control group CG The patients in the RT group follow individualized RT sessions with a physiotherapist daily during the hospitalization and three weekly home sessions on their own after discharge The sessions are structured according to the recommendations of the American College of Sports Medicine ACSM mainly RT
Study population A study of malnourished or at-risk outpatients in our setting was used to calculate the sample size In that study with an alpha error of 005 and a beta of 080 the minimum sample size was 14 participants per group Our objective is to include at least 21 participants per group resulting in a total of 84 participants
Sociodemographic and clinical variables are being collected eg age sex living situation number of drugs falls Information about nutritional and functional status eg MNA gait speed Barthel Lawton and FAC body composition eg weight height body mass index appendicular muscle mass index measured by bioimpedanciometry BIA ultrasound measurements of the anterior rectus area thickness and penation angle and muscle strength hand grip test is also collected
The first descriptive analysis of the variables will include frequencies and percentages for categorical variables and means and standard deviations for continuous variables Changes in nutritional status will be analysed as well as the interaction between nutrition and exercise by repeated measures ANOVA The prevalence of sarcopenia and the influence of each component of the sarcopenia definition on physical performance ADLs emergency room visits and new admissions Additionally a survival analysis will be performed to compare the four groups To assess the quality of ultrasound measurement the relationship between each ultrasound variable and the bioimpedance score as well as the diagnostic criteria for malnutrition and sarcopenia will be analysed Furthermore ultrasound measurements will be correlated with the estimation of muscle mass using bioimpedance analysis A p-value less than 005 will be considered statistically significant
The study is being conducted under the ethical standards set forth by the Comité de Ética de Investigación con Medicamentos CEIm of the Hospital Universitario Ramón y Cajal Each participant is informed about the study and signs the informed consent before inclusion The study has been designed and subsequently evaluated under Law 142007 on Biomedical Research the ethical principles of the Declaration of Helsinki of the World Medical Association on Ethical Principles for Medical Research on Human Beings as well as the other ethical principles and legal regulations applicable according to the characteristics of the study
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