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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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).

Первичные конечные точки

• Function [Срок оценки: Through study completion, an average of 4 days]

Вторичные конечные точки (11)

• Anthropometrical Measurements [Срок оценки: Through study completion, an average of 4 days]
• Dietary intake [Срок оценки: Through study completion, an average of 4 days]
• Number and type of infectious complications [Срок оценки: Through study completion, an average of 4 days]
• Nutritional status biomarkers [Срок оценки: Through study completion, an average of 4 days, and 30 days post-discharge]
• Functional status [Срок оценки: Through study completion, an average of 4 days, and 30 days post-discharge]
• Frailty status [Срок оценки: Baseline]
• Strength of upper and lower limbs [Срок оценки: Through study completion, an average of 4 days]
• Cognitive status [Срок оценки: Through study completion, an average of 4 days]
• Affective status [Срок оценки: Through study completion, an average of 4 days]
• Quality of life of participants [Срок оценки: Through study completion, an average of 4 days]
• Adverse effects possibly attributed to the intervention [Срок оценки: Through study completion, an average of 4 days]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• University Hospital of Navarra — Pamplona

Идентификаторы

NCT: NCT07067697 · NUTPHYS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗