NCT07067697

Impact of Physical Exercise on Hospitalized Older Adults Malnourished or at Risk, With Oral Nutritional Support

The Effect of Physical Exercise on the Physical Function of Hospitalized Older Adults Malnourished or at Risk of Malnourishment With Oral Nutritional Supplementation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Fundacion Miguel Servet · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this research is to analyze whether nutritional intervention combined with a multicomponent physical training program based on strength, balance, and aerobic exercises can prevent disability caused during hospitalization in individuals aged 75 years or older admitted for medical conditions, thereby improving functional and cognitive capacity. To achieve this objective, we will conduct a randomized clinical trial in which patients are randomly assigned to either the control group, which does not perform the physical training, or the intervention group, which participates in the multicomponent physical training program.

Detailed description

The main objective of the present study is to evaluate the differences in the impact of an intervention based solely on physical exercise on the functionality of hospitalized older patients, in an Acute Geriatric Unit, who are malnourished or at risk of malnutrition. As secondary objectives: 1. To assess and compare changes in body composition following the intervention during hospitalization. 2. To evaluate and compare dietary intake, appetite progression, and food consumption throughout the intervention period. 3. To compare in-hospital infectious complications between the two groups. 4. To describe and compare changes in nutritional biochemical parameters between groups after the intervention and 30 days post-discharge. 5. To study changes in other physical function measures throughout the study period and compare them. 6. To describe the presence of molecular markers related to senescence and sarcopenia in patients and compare them between groups at discharge. 7. To study and compare changes in participants' cognitive status. 8. To evaluate and compare changes in perceived quality of life. 9. To assess and compare changes in maximal dynamic strength before and after the intervention. 10. To describe and compare hospital stays and 30-day readmission rates of study participants. 11. To describe participants' personal satisfaction with the intervention. 12. To describe the presence of potential side effects attributed to the intervention during the study period.

Conditions

• Hospitalized
• Older Adults
• Physical Exercise
• Oral Nutritional Supplementation

Interventions

Type	Name	Description
OTHER	Physical exercise	Progressive, supervised multicomponent physical exercise program, including aerobic resistance, strength, and balance training. Strength training for lower limbs (leg press and knee extension) and upper limbs (seated chest press) will be adapted to each individual's functional capacity.
OTHER	Usual Care	* Hospital physiotherapy for preventing nosocomial disability when necessary. * Hospital diet modifications appropriate to each participant's clinical situation. * Oral nutritional supplementation aimed at meeting daily nutritional requirements: 30 kcal/kg body weight, 1.5-2 g protein/kg body weight, 25 g daily fiber. * Approximate free water intake: women 1.5 L/day, men 2 L/day (unless clinically restricted).

Timeline

• Start date: 2025-07-14
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-07-16
• Last updated: 2025-09-24

Locations

1 site across 1 country: Spain