RecruitingNot ApplicableNCT07067697

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


Sponsor

Fundacion Miguel Servet

Enrollment

102 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 75 Years

Inclusion Criteria9

  • Aged 75 years or above
  • Hospitalized in the Acute Unit of the Geriatrics Service at the University Hospital of Navarra
  • 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 Criteria6

  • 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.

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Interventions

OTHERPhysical 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.

OTHERUsual 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).


Locations(1)

University Hospital of Navarra

Pamplona, Navarre, Spain

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NCT07067697


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