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

ConditionsHospitalizedOlder AdultsPhysical ExerciseOral Nutritional Supplementation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorFundacion Miguel Servet

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical exercise

    Other intervention

    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 intervention

    * 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).

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Function

SPPB - Short Physical Performance Battery

Time frame
Through study completion, an average of 4 days

Secondary outcomes

1

Anthropometrical Measurements

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)

Time frame
Through study completion, an average of 4 days
2

Dietary intake

Semi-quantitative questionnaire and a daily appetite assessment

Time frame
Through study completion, an average of 4 days
3

Number and type of infectious complications

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

Nutritional status biomarkers

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

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

Other outcomes

Sponsors and contacts

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Fundacion Miguel Servet

Lead sponsor

Nestle Health Science

Collaborator

Source ClinicalTrials.gov
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