NCT07067697招募中不适用
The Effect of Physical Exercise on the Physical Function of Hospitalized Older Adults Malnourished or at Risk of Malnourishment With Oral Nutritional Supplementation
Fundacion Miguel Servet2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年7月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Function
时间窗: Through study completion, an average of 4 days
SPPB - Short Physical Performance Battery
次要结局
- Anthropometrical Measurements(Through study completion, an average of 4 days)
- Dietary intake(Through study completion, an average of 4 days)
- Nutritional status biomarkers(Through study completion, an average of 4 days, and 30 days post-discharge)
- Number and type of infectious complications(Through study completion, an average of 4 days)
- Frailty status(Baseline)
- Quality of life of participants(Through study completion, an average of 4 days)
- Functional status(Through study completion, an average of 4 days, and 30 days post-discharge)
- Adverse effects possibly attributed to the intervention(Through study completion, an average of 4 days)
- Strength of upper and lower limbs(Through study completion, an average of 4 days)
- Affective status(Through study completion, an average of 4 days)
- Cognitive status(Through study completion, an average of 4 days)
研究者
研究点 (2)
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