FAME 1: The Effects of Apathy on Different Forms of Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.
研究概览
简要总结
60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital and from the " Fragilily " Platform of the Nice University Hospital.
After verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity.
Afterwards, participants will have to complete assessments and questionnaires to evaluate apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale).
Regarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game 'Tap-piscine').
The total duration of the evaluation is a maximum of 2 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged between 65 and 85 years old coming for consultation at the RMC and the Fragility Platform
- •DSM-5 diagnosis: minor neurocognitive disorders
- •Subject must read and write in French.
- •Subject must be registered in the national social security scheme.
- •Ability to sign free and informed consent.
- •For the 'apathetic' group:
- •- Presence of apathy/emotional symptoms: at least 2 criteria according to the diagnostic criteria for apathy and a score higher than 8.5 in the MBI affective dimension.
- •For the 'non-apathetic' group:
- •- Absence of apathy/emotional symptoms: no criteria according to the diagnostic criteria for apathy and a score of less than 8.5 in the MBI affective dimension.
排除标准
- •Motor or sensory disabilities likely to interfere with the tests.
- •Presence of major psychiatric disorders (e.g., schizophrenia, major depressive episode, bipolar disorder)
- •Patient under guardianship, curatorship or under legal protection
结局指标
主要结局
comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.
时间窗: at inclusion
the minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)
次要结局
未报告次要终点