Exercise plus oral nutrition to prevent disability in hospitalized adults 75 and older

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized clinical trial in an Acute Geriatric Unit enrolling patients aged 75+ who are malnourished or at risk; participants are randomly assigned to usual care with oral nutritional support or to the same care plus a supervised multicomponent physical training program (strength, balance, and aerobic exercises). The intervention is delivered during the hospital stay and outcomes are measured at discharge and 30 days post-discharge. Primary outcomes focus on functional status and prevention of hospital-acquired disability, with secondary outcomes including body composition, dietary intake, infections, biochemical nutritional markers, physical performance measures, cognitive status, quality of life, strength, hospital length of stay, readmissions, participant satisfaction, and adverse events. The trial is conducted at the University Hospital of Navarra with collaboration from Nestlé Health Science.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 75 years or above
* Hospitalized in the Acute Unit of the Geriatrics Service at the University Hospital of Navarra
* 4 days or more of expected hospitalization
* Malnourished according to the GLIM criteria or at risk of malnourishment (MUST scale)
* Barthel Index ≥ 60 points
* Capable of tolerating oral intake
* Able to walk (with or without assistance)
* Able to understand instructions and communicate
* Consent to participate in the study after being informed of its objectives and who sign the informed consent (the participant or their legal guardian in case of disability).

Exclusion Criteria:

* Advanced major neurocognitive disorder (GDS 6 and 7)
* Uncontrolled cardiac arrhythmia, acute pulmonary thromboembolism, acute myocardial infarction, or bone fractures within the last 3 months
* Chronic kidney disease stage 4 or 5
* Safe and effective swallowing only with pudding texture
* Inability to participate in the physical exercise program due to physical limitations
* Participate in another study that may interfere with data interpretation or have participated in another study in six months prior to their entry into the study.

Where it's running

• University Hospital of Navarra
  Pamplona, Navarre, Spain Recruiting

Study contacts

• Study coordinator: Chenhui Chen, Doctor
• Email: chenhuichen253@gmail.com
• Phone: +34 664426191

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.