Multicomponent Exercise to Prevent Hospitalization-Associated Disability (FIS_Prevention)
2026年7月15日 更新者：Fundacion Miguel Servet
Prevention of Disability in Older Adults: From the Patient to the Molecule - A Randomized Controlled Trial (RCT)
The study is a randomized controlled trial conducted in the Geriatrics Department of a tertiary hospital in Spain (Hospital Universitario de Navarra). Participants aged 75 years or older will be recruited within the first 48 hours of admission to the acute care ward. Eligible hospitalized patients will be randomly assigned to either the intervention or control group using permuted block randomization (block sizes of 8 and 10), with consideration of gender balance.
Data will be collected at four time points: baseline assessment, hospital discharge, 1 month, and 3 months post-discharge.
Inclusion criteria include age ≥75 years and admission to the acute care unit. Exclusion criteria include refusal or inability to provide informed consent, life expectancy <3 months or terminal illness (oncological or non-oncological), inability to complete follow-up, medical contraindications to exercise, severe neurocognitive impairment (GDS-FAST stage 7), or severe disability (Barthel Index <35).
研究概览
详细说明
General Objective
To determine whether an intervention consisting of a multicomponent physical exercise program based on strength, balance, and aerobic training can prevent hospitalization-associated disability in adults aged 75 years and older admitted for acute medical conditions, while improving functional and cognitive capacity.
Specific Objectives
- To analyze and identify the patient subgroups that derive the greatest benefit from the intervention in order to optimize healthcare resource allocation (e.g., frail patients, patients with cognitive impairment, malnourished patients), and to characterize these subgroups.
- To identify the sociodemographic, clinical, functional, and cognitive characteristics associated with greater responsiveness to the intervention, as well as the type of intervention that provides the greatest benefit.
- To integrate clinical and molecular approaches through the assessment of epigenetic and inflammatory biomarkers, enabling the evaluation of parameters that have not previously been incorporated into studies of this kind.
研究类型
介入性
注册 (估计的)
300
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Nicolas Martinez-Velilla
- 电话号码：+34 848422287
- 邮箱：nicolas.martinez.velilla@navarra.es
研究联系人备份
- 姓名：Fabricio Zambom-Ferraresi
- 电话号码：+34 848422287
- 邮箱：fabricio.zambom.ferraresi@navarra.es
学习地点
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Pamplona、西班牙、31008
- 招聘中
- Hospital Universitario de Navarra
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接触：
- Nicolas Martinez-Velilla
- 电话号码：+34 848422287
- 邮箱：nicolas.martinez.velilla@navarra.es
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Age equal to or greater than 75 years, admitted to the acute care unit for medical conditions.
Exclusion Criteria:
- Explicit refusal expressed verbally or refusal to sign the informed consent by the patient/main caregiver/legal guardian or inability to obtain it.
- Life expectancy of less than 3 months or terminal oncological or non -oncological disease.
- Inability to follow up.
- Inability to participate in a multicomponent exercise program.
- Medical contraindication to exercise.
- Major neurocognitive disorder at moderate to severe stage (GDS - Fast Reisberg 5-7).
- Moderate to severe disability (measured by the Barthel Index (BI <60)). Expected hospital stay of less than 6 days.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：No exercise during hospitalization
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实验性的：Exercise during hospitalization
Multicomponent individualized exercise intervention As mentioned earlier, patients in the control group (G0) will receive the usual care currently provided to other patients, which includes a referral to physical therapy if needed.
The intervention for the multicomponent physical exercise intervention group (G1) will consist of a multicomponent physical training program that includes progressive and supervised aerobic endurance, strength, and balance training lasting 4-7 days during their hospitalization.
This will be supervised by the research team from the Geriatrics Unit.
Additionally, after hospital discharge, they will receive individualized guidelines to engage in multicomponent physical exercise for 3 months, along with individualized recommendations from the Nutrition and Dietetics Service of HUN.
The multicomponent physical training program will consist of chair squat exercises.
The main part of the training will utilize machines for strength training for the lower extremit
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Multicomponent individualized exercise intervention As mentioned earlier, patients in the control group (G0) will receive the usual care currently provided to other patients, which includes a referral to physical therapy if needed.
The intervention for the multicomponent physical exercise intervention group (G1) will consist of a multicomponent physical training program that includes progressive and supervised aerobic endurance, strength, and balance training lasting 4-7 days during their hospitalization.
This will be supervised by the research team from the Geriatrics Unit.
Additionally, after hospital discharge, they will receive individualized guidelines to engage in multicomponent physical exercise for 3 months, along with individualized recommendations from the Nutrition and Dietetics Service of HUN.
The multicomponent physical training program will consist of chair squat exercises.
The main part of the training will utilize machines for strength training for the lower extremit
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
功能状态
大体时间：通过学习完成，平均3个月
|
短期性能物理电池（SPPB）
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通过学习完成，平均3个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
迷你委员会考试（MMSE）
大体时间：通过学习完成，平均3个月
|
认识
|
通过学习完成，平均3个月
|
|
越野测试
大体时间：通过学习完成，平均3个月
|
复杂的关注
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通过学习完成，平均3个月
|
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GDS YESAVAGE
大体时间：通过学习完成，平均3个月
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沮丧
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通过学习完成，平均3个月
|
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EUROQOL-5D-3L
大体时间：通过学习完成，平均3个月
|
生活质量
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通过学习完成，平均3个月
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药物数量
大体时间：通过学习完成，平均3个月
|
DE干预前后的药物数量
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通过学习完成，平均3个月
|
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瀑布
大体时间：通过学习完成，平均3个月
|
研究期间的跌倒次数
|
通过学习完成，平均3个月
|
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死亡
大体时间：通过学习完成，平均3个月
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研究期间的死亡率
|
通过学习完成，平均3个月
|
|
手握
大体时间：通过学习完成，平均3个月
|
最大等距强度
|
通过学习完成，平均3个月
|
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规模
大体时间：通过学习完成，平均3个月
|
睡眠质量的变化
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通过学习完成，平均3个月
|
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Barthel Index
大体时间：Through study completion, an average of 3 months]
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Basic activities of daily living
|
Through study completion, an average of 3 months]
|
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Hospital Readmissions
大体时间：Through study completion, an average of 3 months
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Number of Hospital Readmissions
|
Through study completion, an average of 3 months
|
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Length of stay
大体时间：Through study completion, an average of 3 months
|
Average length of hospital stay
|
Through study completion, an average of 3 months
|
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Changes in plasma/serum proteomic profiles.
大体时间：Through study completion, an average of 3 months
|
Protein expression profiles will be assessed to identify changes in circulating proteins associated with the intervention and to explore potential biological pathways involved in the observed effects
|
Through study completion, an average of 3 months
|
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Changes in DNA methylation profiles and epigenetic age
大体时间：Through study completion, an average of 3 months
|
Buffy coat samples will be used for DNA extraction.
Extracted DNA will be hybridized on DNA methylation arrays to assess genome-wide methylation profiles and identify differentially methylated regions/sites associated with the intervention.
DNA methylation data will also be used to estimate biological age through established epigenetic clocks, allowing the evaluation of changes in epigenetic age and/or epigenetic age acceleration.
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Through study completion, an average of 3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nicolas Martinez-Velilla、Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年2月1日
初级完成 (估计的)
2027年11月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年7月3日
首先提交符合 QC 标准的
2026年7月15日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月15日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.