Prevention of Disability in Older Adults: From the Patient to the Molecule - A Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Functional status
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age equal to or greater than 75 years, admitted to the acute care unit for medical conditions.
排除标准
- •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.
结局指标
主要结局
Functional status
时间窗: Through study completion, an average of 3 months
Short Performance Physical Battery (SPPB)
次要结局
- SATED scale(Through study completion, an average of 3 months)
- Barthel Index(Through study completion, an average of 3 months])
- Mini-Mental State Examination (MMSE)(Through study completion, an average of 3 months)
- Trail Making Test A(Through study completion, an average of 3 months)
- GDS Yesavage(Through study completion, an average of 3 months)
- EuroQol-5D-3L(Through study completion, an average of 3 months)
- Number of medications(Through study completion, an average of 3 months)
- Falls(Through study completion, an average of 3 months)
- Mortality(Through study completion, an average of 3 months)
- Hospital Readmissions(Through study completion, an average of 3 months)
- Hand Grip(Through study completion, an average of 3 months)
- Length of stay(Through study completion, an average of 3 months)
- Changes in plasma/serum proteomic profiles.(Through study completion, an average of 3 months)
- Changes in DNA methylation profiles and epigenetic age(Through study completion, an average of 3 months)