Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Oncogeriatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in cognitive function: Minimental State Evaluation (MMSE; Spanish version)
研究概览
简要总结
Hospitalized older patients usually remain bedridden for many hours and this may lead to the appearance of unwanted negative consequences, such as cognitive or physical decline upon discharge. Our study will analyze whether an intervention consisting of a multicomponent training programme applied to patients over the age of 60 who are hospitalized for acute medical conditions in an Oncology Department of a tertiary hospital improves functional capacity and cognitive function. A total of 50 hospitalized older adult patients will be recruited in the Hospital Universitario de Navarra, Pamplona, Spain. The participants will be randomized and included in an exercise intervention (n = 25) or a control (n = 25) group (hospital usual-care). The intervention consists of a multicomponent exercise training programme that will take place for 3 consecutive days (2 sessions/day). The control group will receive usual hospital care, which will include physical rehabilitation when needed. Functional and cognitive impairment after and during acute hospitalization in older adults are major determinants of the later need for health resources. If our hypothesis is correct and shows that a multicomponent, individualized and progressive exercise programme is an effective therapy for improving the functional capacity of acutely hospitalized older patients compared to usual care, a change in the current system of hospitalization may be justified in oncogeriatric patients with medical conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 65 years
- •Barthel Index ≥60 points
- •Able to ambulate (with/without assistance)
- •Sign the informed consent
- •Able to communicate
排除标准
- •Expected length of stay < 6 days
- •Terminal illness
- •Very severe cognitive decline (i.e., GDS 7)
- •Uncontrolled arrhythmias, acute pulmonary embolism, acute myocardial infarction or limb bone fracture in the past 3 months.
结局指标
主要结局
Change in cognitive function: Minimental State Evaluation (MMSE; Spanish version)
时间窗: 12 months
The change in MMSE will be measured at baseline and follow-up. Minimum 1 Maximum 35 Higher scores mean a better outcome
Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión)
时间窗: 12 months
The change in SPPB measured at baseline and follow-up (a measure of balance, gait, and rising from a chair) Minimum 1 Maximum 12 Higher scores mean a better outcome
次要结局
- Change in functional capacity: Barthel Index (spanish version)(12 months)
- Changes in mood status: the 15-item Yesavage Geriatric Depression Scale (GDS-VE), Spanish version(12 months)
- Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire(12 months)
- Changes in handgrip strength (dominant hand)(12 months)
- Gait ability will be assessed using the 6-metre gait velocity test (GVT)(12 months)
- Changes in the Trail Making Test (TMT) part A(12 months)
- Dual task GVT (verbal GVT and arithmetic GVT)(12 months)