Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07067697

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Navarra

Pamplona, Navarre, 31008, Spain

Location status: Recruiting

Location contact

Nicolás Martínez-Velilla, Doctor

CONTACT

[email protected]

+34 670900434

About this study

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:

  • To assess and compare changes in body composition following the intervention during hospitalization.
  • To evaluate and compare dietary intake, appetite progression, and food consumption throughout the intervention period.
  • To compare in-hospital infectious complications between the two groups.
  • To describe and compare changes in nutritional biochemical parameters between groups after the intervention and 30 days post-discharge.
  • To study changes in other physical function measures throughout the study period and compare them.
  • To describe the presence of molecular markers related to senescence and sarcopenia in patients and compare them between groups at discharge.
  • To study and compare changes in participants' cognitive status.
  • To evaluate and compare changes in perceived quality of life.
  • To assess and compare changes in maximal dynamic strength before and after the intervention.
  • To describe and compare hospital stays and 30-day readmission rates of study participants.
  • To describe participants' personal satisfaction with the intervention.
  • To describe the presence of potential side effects attributed to the intervention during the study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

  1. Function

    Time frame: Through study completion, an average of 4 days

    SPPB - Short Physical Performance Battery

Secondary outcomes

  1. Anthropometrical Measurements

    Time frame: Through study completion, an average of 4 days

    Bioimpedance: PHASE ANGLE (PhA), Fat-Free Mass (FFM) and Muscle Mass (MM). Conventional and vectorial bioelectrical impedance analysis with a single-frequency bioelectrical impedance analyzer at 50 kHz (BIA 101 RJL, Akern Bioresearch, Florence, Italy)

  2. Dietary intake

    Time frame: Through study completion, an average of 4 days

    Semi-quantitative questionnaire and a daily appetite assessment

  3. Number and type of infectious complications

    Time frame: Through study completion, an average of 4 days

  4. Nutritional status biomarkers

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

    In blood: proteins, prealbumin, albumin, transferrin, lymphocytes, 25-hydroxyvitamin D, C-reactive protein.

  5. Functional status

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

    Barthel Index, Lawton Index

  6. Frailty status

    Time frame: Baseline

    Linda Fried's Frailty Scale, from 0 to 5 (0 robust; 1,2 pre-frail; 3 to 5 frail).

  7. Strength of upper and lower limbs

    Time frame: Through study completion, an average of 4 days

    Leg press, chest press, knee extension, and handgrip strength

  8. Cognitive status

    Time frame: Through study completion, an average of 4 days

    Mini-Mental State Examination, 4AT

  9. Affective status

    Time frame: Through study completion, an average of 4 days

    Yesavage's 15-item Geriatric Depression Scale (GDS-15)

  10. Quality of life of participants

    Time frame: Through study completion, an average of 4 days

    EuroQoL-5D-3L

  11. Adverse effects possibly attributed to the intervention

    Time frame: Through study completion, an average of 4 days

Study contacts

Contact information is provided by the study sponsor or research team.

Chenhui Chen, Doctor

CONTACT

[email protected]

+34 664426191

Nicolás Martínez Velilla, Doctor, MD, PhD

CONTACT

[email protected]

00 34 848422222

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Collaborators

  • Nestle Health Science

Registry information

Official study title

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

Acronym: NUTPHYS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.