NCT04746768Unknown不适用
Impact of Exercise and Nutritional Support on the Frailty Syndrome of Eldery Patients in Phase of Post-cancer Treatment
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of the prevalence of frailty syndrome in individuals with complete response of cancer
研究概览
简要总结
Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •in complete remission from cancer (all type of cancer)
- •have a frailty syndrome (positive GFST score)
- •ability to provide signed informed consent
- •be affiliated with social security or beneficiary of such a scheme
排除标准
- •patient with active cancer or any other pathology affecting the prognosis at 5 years
- •currently participating or having participated in the month preceding inclusion in another interventional clinical research that may impact the study. This impact is left to the investigator discretion
- •subjects referred to articles L1121-5 to L1121-8 of CSP (corresponds to all protected persons: person deprived of liberty by judicial or administrative decision, person subject to legal protection measure)
结局指标
主要结局
Change of the prevalence of frailty syndrome in individuals with complete response of cancer
时间窗: 0, 6 and 12 months
evolution of individual frailty during a multimodal intervention (physical and nutritional activity) according to the Fried's criteria
次要结局
- Change from baseline nutritional status during nutritionist support (month 3 and 6) and at the end of empowerment (month 12)(Month 0, 3, 6 and 12)
- Measure adherence to APA interventions and exercise practices(between month 1 to 6 and between month 6 to 12)
- Measure the durability of long-term activities(Month 6 and 12)
- Correlations between physical performance and frailty syndrome and their evolutions(Month 0, 6 and 12)
- evaluation of predicitive variables of frailty syndrome reversion(Month 0, 6 and 12)
- Estimation of adherence to nutritional interventions(Month 6 and 12)
- Measure health related quality of life on mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression(Month 0, 6 and 12)
- Sociological study on motivation: evaluation of the perception and experience of treating patients(Month 6 and 12)
研究者
研究点 (1)
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