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

NCT06607718 | Completed

• 1 other identifier: 041/23
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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..

Conditions

Malnutrition; Protein; Older; Sarcopenia

Keywords

Oral Nutritional Supplementation; Resistance trainning; Sarcopenia; Older adults; Acute Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Hand grip test

  12 weeks

• Body Mass Index (BMI)

  12 weeks

• Appendicular Skeletal Muscle mass Index (ASMI)

  12 weeks

• 4-m-test

  12 weeks

• Barthel's index

  12 weeks

Study Arms (4)

Resistance Training (RT)

EXPERIMENTAL

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

Oral Nutritional Supplementation (ONS)

EXPERIMENTAL

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

Control Group (CG)

SHAM COMPARATOR

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

Resistance Training (RT) and Oral Nutritional Supplementation (ONS)

EXPERIMENTAL

They receive joint treatment

Other: Resistance Training; Dietary Supplement: Oral Nutritional Supplementation

Interventions

Resistance Training OTHER

Resistance training for elderly patients in the acute care unit.

Also known as: RT

Resistance Training (RT); Resistance Training (RT) and Oral Nutritional Supplementation (ONS)

Oral Nutritional Supplementation DIETARY_SUPPLEMENT

To receive two daily packs of a hypercaloric and hyperproteic oral nutritional supplement for 3 months.

Also known as: ONS

Oral Nutritional Supplementation (ONS); Resistance Training (RT) and Oral Nutritional Supplementation (ONS)

Control Group OTHER

No intervention

Also known as: CG

Control Group (CG)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Kwashiorkor; Sarcopenia

Interventions

Resistance Training; Dietary Supplements; Control Groups

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Beatriz Montero-Errasquín, Dra.

  Hospital Ramon y Cajal.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ultrasound measurements, MNA and bioimpedance are being performed at all three visits by an investigator blinded to the assigned group. In addition, the person carrying out the data analysis will also be blinded to the assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, controlled, pragmatic study with blinded outcome measurement.

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 23, 2024
• Study Start: May 11, 2023
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)