Spanish Cohort of Patients With HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 802
- 主要终点
- To study the prognostic value of the CD4 / CD8 ratio in relation to frailty
研究概览
简要总结
It's a prospective observational study to assess frailty and physical function
详细描述
We stimate to recruit 1120 patients older tan 50 years to assess frailty and define a simplified fragility index
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed HIV + infection.
- •Patients aged ≥ 50 years at the time of starting the study, followed in the Infectious-HIV consultations of the centers participants.
- •This limit has been chosen because it is accepted by the scientific community for define the elderly patient in patients with HIV infection.
- •Have signed the informed consent and be willing to comply with the study visits.
排除标准
- •Have an established disability that does not allow you to walk.
- •Patients who can not comply with the visits and study procedures or who are not usually followed at the center.
结局指标
主要结局
To study the prognostic value of the CD4 / CD8 ratio in relation to frailty
时间窗: Change from Basal to Year 5
Analyze the relationship between exposure time to different families of antiretroviral drugs with fragility.
时间窗: Change from Basal to Year 5
Define a new simplified fragility index for the elderly patients with HIV infection easily applicable in clinical routine practice
时间窗: Year 5
The simplified fragility index for the elderly patient with HIV infection can not be defined a priori, so a multivariate logistic regression analysis will be performed for those variables that are associated with fragility in the analysis univariate, which will allow us to determine the variables that are associated in a independent with fragility, which will be with which we will define the fragility index simplified. Fragility will be treated as a binary variable: pre-fragile and robust will form a group that will serve as control. The fragility phenotype defined by the 5 Fried criteria will be considered the gold standard test to measure fragility when validating the simplified fragility screening test specific for elderly patients with HIV infection that we want to define
To know the prevalence of frailty in the population over 50 years old with HIV infection according to Fried's fragility phenotype
时间窗: Change from basal to year 5
Fragility is defined according to the 5 Fried criteria: * Involuntary weight loss: (\> 4.5Kg in the last year) * Declined mood: through two questions from the Scale for Depression of the Center for Epidemiological Studies (CES-D). * Speed of walking adjusted for height and sex, * Weekly physical activity adjusted by sex. * Muscle weakness according to manual grip strength adjusted for BMI and sex.
Define fragility biomarkers
时间窗: Change from Basal to Year 5
immunological profile, oxidative damage, microbiome.
次要结局
- Analyze the possible association of fragility in this population group with the comorbidity and the presence of other geriatric syndromes(Year 1, year 2, year 3, year 4 and year 5)
- To know the prevalence of other geriatric syndromes(Year 1, year 2, year 3, year 4 and year 5)
- To know the risk of fragility fractures in the population over 50 years old with HIV infection in our cohort(Year 1, year 2, year 3, year 4 and year 5)
- Know the functional situation and the risk of functional deterioration of the population over 50 years of age with HIV infection in our cohort(Year 1, year 2, year 3, year 4 and year 5)
- To analyze the possible association of bone fragility with the presence of the syndrome clinical of fragility in this population group(Year 1, year 2, year 3, year 4 and year 5)