Nutritional and Exercise Intervention in Older Adults Admitted to the Acute Care Unit (SERIA) (SERIA)

Hyperproteic Oral Supplementation With Vitamin D and Resistance Training in Older Patients Admitted to the Acute Unit (SERIA)

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..

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Malnutrition; Protein; Older
• Intervention / Treatment: Other: Control Group; Other: Resistance Training; Dietary supplement: Oral Nutritional Supplementation

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 (RT+ONS); 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 0.05 and a beta of 0.80, 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 (e.g., age, sex, living situation, number of drugs, falls). Information about nutritional and functional status (e.g., MNA, gait speed, Barthel, Lawton, and FAC), body composition (e.g., 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 0.05 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 14/2007 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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients admitted to the Unidad de Agudos (Geriatric Acute Care) del Servicio de Geriatría at HU Ramón y Cajal who are at risk of malnutrition or malnutrition (defined with a MNA-SF score ≤ 11) and who sign the informed consent form.

Exclusion Criteria:

• patients with estimated discharge within 72 hours.
• Re-admissions (defined as previous admission in the Geriatric Acute Care in the last 3 months)
• Patients taking ONS for more than two weeks.at the time of admission.
• Patients suffering any illness or condition that prevents or contraindicates resistance physical exercise. and oral food intake.
• Food allergies or intolerances that contraindicate the SNO.
• Patients with advanced dementia (GDS stage 7) or palliative care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance Training (RT); They are performing programmed physical exercise started on the day of admission, focusing on muscle strength gain, and they are being taught how to continue exercising three times a week after discharge from hospital. Lower limb strength exercises (squats and knee extensions) and upper limb strength exercises (elbow flexion, lateral and frontal raises, and tractions) were performed. A progression of the load are being made by increasing one set per month and 2 to 4 repetitions per month depending on the patient's capabilities.	Other: Resistance Training; Resistance training for elderly patients in the acute care unit.; Other Names: RT
Experimental: Oral Nutritional Supplementation (ONS); They are receiving a hypercaloric, hyperproteic, oral nutritional supplement with vitamin D and CaHMB (ß-hydroxy-ß-methylbutyrate) (Ensure Plus Advance®), at a dose of two packets per day in two or more doses for 3 months.	Dietary supplement: Oral Nutritional Supplementation; To receive two daily packs of a hypercaloric and hyperproteic oral nutritional supplement for 3 months.; Other Names: ONS
Sham Comparator: Control Group (CG); They are being treated according to standard clinical practice, which includes information from the health professionals on the ward on recommended dietary and exercise guidelines. When the treating team considers the use of an oral nutritional supplement to be indicated, it is being prescribed.	Other: Control Group; No intervention; Other Names: CG
Experimental: Resistance Training (RT) and Oral Nutritional Supplementation (ONS); They receive joint treatment	Other: Resistance Training; Resistance training for elderly patients in the acute care unit.; Other Names: RT; Dietary supplement: Oral Nutritional Supplementation; To receive two daily packs of a hypercaloric and hyperproteic oral nutritional supplement for 3 months.; Other Names: ONS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Nutritional Assessment (MNA)	Screening tool to help identify malnourished elderly people or those at risk of malnutrition on a scale of 0 to 30. The higher the value, the better the nutritional status of the older adult.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip test	Measurement of hand grip strength using a hand-held dynamometer.	12 weeks
Body Mass Index (BMI)	Is a mathematical ratio that associates the mass and the size of an individual BMI = weight / height ^2	12 weeks
Appendicular Skeletal Muscle mass Index (ASMI)	It is the sum of muscle masses of the four limbs measured with BIA.	12 weeks
4-m-test	It consists of assessing the patient's usual walking speed over a distance of 4 metres.	12 weeks
Barthel's index	Test to assess the patient's ability to perform basic activities of daily living on a scale of 0 to 100. The higher the value, the greater the independence of the older adult.	12 weeks
Lawton-Brody scale	Test to assess the patient's ability to perform instrumental activities of daily living on a scale of 0 to 8. The higher the score, the greater the functional capacity of the older adult.	12 weeks
Functional Ambulation Classification (FAC)	Test to assess a person's ability to walk with a score from 0 to 5. The higher the score, the greater the walking independence.	12 weeks
Thickness	An ultrasound is performed in the middle of the anterior rectus, measuring from the patella to the anteroinferior iliac spine. Through a cross section the image is frozen and a straight line of the thickness of the center of the anterior rectus is drawn at that point. The distance is noted in mm.	12 weeks
Penile angle of a muscle	An ultrasound is performed in the middle of the anterior rectus, measuring from the patella to the anteroinferior iliac spine. Unlike the other measurements, the ultrasound image is taken in the longitudinal section. The penile angle of a muscle is the orientation of the muscle fibers in relation to the connective tissue/tendon. It is taken by fixing one side of the angle on the connective tissue and the other side on the orientation of the muscle fibers. The value is noted in degrees.	12 weeks
Cross-sectional area	An ultrasound is performed in the middle of the anterior rectus, measuring from the patella to the anteroinferior iliac spine. Through a cross section the image is frozen and the area of the volume of the anterior rectum at that point is traced. The area is noted in cm^2.	12 weeks

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Investigators: Principal Investigator: Beatriz Montero-Errasquín, Dra., Hospital Ramon y Cajal.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Sarcopenia; Older adults; Acute Care; Oral Nutritional Supplementation; Resistance trainning
• Additional Relevant MeSH Terms: Severe Acute Malnutrition; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Nutrition Disorders; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Malnutrition; Sarcopenia; Kwashiorkor
• Other Study ID Numbers: 041/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No personal information will be shared. At the time of enrolment, each participant will be given a code. The full database of outcome variables will also not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No