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

NCT07067697 | Recruiting

• 1 other identifier: NUTPHYS
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hospitalized; Older Adults; Physical Exercise; Oral Nutritional Supplementation

Keywords

hospital-acquired disability; older adults; physical exercise; oral nutritional supplementation

Outcome Measures

Primary Outcomes (1)

• Function

  SPPB - Short Physical Performance Battery

  Through study completion, an average of 4 days

Secondary Outcomes (11)

• Anthropometrical Measurements

  Through study completion, an average of 4 days

• Dietary intake

  Through study completion, an average of 4 days

• Number and type of infectious complications

  Through study completion, an average of 4 days

• Nutritional status biomarkers

  Through study completion, an average of 4 days, and 30 days post-discharge

• Functional status

  Through study completion, an average of 4 days, and 30 days post-discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Participants included in this group will perform physical exercise

Other: Physical exercise

Control

ACTIVE COMPARATOR

Participants in this group will receive attention from a physiotherapist if needed.

Other: Usual Care

Interventions

Physical exercise OTHER

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.

Intervention

Usual Care OTHER

* 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).

Control

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Nestle Health Science: collaborator

Study Sites (1)

University Hospital of Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Chenhui Chen, Doctor

CONTACT

+34 664426191; chenhuichen253@gmail.com

Nicolás Martínez Velilla, Doctor, MD, PhD

CONTACT

00 34 848422222; nicolas.martinez.velilla@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 16, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)