Spanish Cohort of Patients With HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function

HIV Infections Clinical Trial

— FUNCFRAIL  

Official title:

Spanish Cohort of Patients With HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03558438
• Other study ID #: GESIDA 9817
• Status: Active, not recruiting
• Start date: May 7, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It's a prospective observational study to assess frailty and physical function

Description:

We stimate to recruit 1120 patients older tan 50 years to assess frailty and define a simplified fragility index

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 802
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Patients with confirmed HIV + infection.

2. 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.

3. Have signed the informed consent and be willing to comply with the study visits.

Exclusion Criteria:

1. Have an established disability that does not allow you to walk.

2. Patients who can not comply with the visits and study procedures or who are not usually followed at the center.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Frail Older Adults
• HIV Infections
• Infections

Intervention

Other:
• No interventions
No interventions

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital Reina Sofia	Córdoba
Spain	Hospital de Donostia	Donostia
Spain	Hospital de Guadalajara	Guadalajara
Spain	Clínico San Carlos	Madrid
Spain	Hospital Fundación Jimenez Diaz	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Univ. La Paz	Madrid
Spain	Hospital de Santiago	Santiago De Compostela
Spain	Hospital Clínic de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To know the prevalence of frailty in the population over 50 years old with HIV infection according to Fried's fragility phenotype	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.	Change from basal to year 5
Primary	Define a new simplified fragility index for the elderly patients with HIV infection easily applicable in clinical routine practice	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	Year 5
Primary	To study the prognostic value of the CD4 / CD8 ratio in relation to frailty		Change from Basal to Year 5
Primary	Analyze the relationship between exposure time to different families of antiretroviral drugs with fragility.		Change from Basal to Year 5
Primary	Define fragility biomarkers	immunological profile, oxidative damage, microbiome.	Change from Basal to Year 5
Secondary	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
Secondary	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
Secondary	To know the prevalence of other geriatric syndromes	polypharmacy, falls, cognitive impairment, depression, risk of malnutrition.	Year 1, year 2, year 3, year 4 and year 5
Secondary	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
Secondary	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