Exercise plus oral nutrition to prevent disability in hospitalized adults 75 and older
The Effect of Physical Exercise on the Physical Function of Hospitalized Older Adults Malnourished or at Risk of Malnourishment With Oral Nutritional Supplementation
NA · Fundacion Miguel Servet · NCT07067697
We will test whether adding a supervised multicomponent exercise program to oral nutritional support helps hospitalized people aged 75 and older who are malnourished or at risk avoid disability and improve physical and cognitive function.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Fundacion Miguel Servet (other) |
| Locations | 1 site (Pamplona, Navarre) |
| Trial ID | NCT07067697 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 75 or older admitted to the Acute Geriatrics Unit at the University Hospital of Navarra who are malnourished or at risk, can tolerate oral intake, are able to walk (with or without assistance), have a Barthel Index ≥ 60, can follow instructions, and expect a hospital stay of four days or more.
Not a fit: Patients unlikely to benefit include those with advanced major neurocognitive disorder (GDS 6–7), recent major cardiac events or fractures, uncontrolled arrhythmia or acute thromboembolism, chronic kidney disease stage 4–5, severe swallowing impairment requiring non-standard textures, or any condition that prevents safe participation in the exercise program.
Why it matters
Potential benefit: If successful, the intervention could reduce hospital-acquired disability in older patients, improving strength, function, and possibly shortening stays and reducing readmissions.
How similar studies have performed: Previous trials combining in-hospital exercise and nutritional support have reported some improvements in function and reduced decline, but results are mixed and larger definitive trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pamplona, Navarre
- University Hospital of Navarra — Pamplona, Navarre, Spain (RECRUITING)
Study contacts
- Study coordinator: Chenhui Chen, Doctor
- Email: chenhuichen253@gmail.com
- Phone: +34 664426191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hospitalized, Older Adults, Physical Exercise, Oral Nutritional Supplementation, hospital-acquired disability, older adults, physical exercise, oral nutritional supplementation