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Active, Not Recruiting

NCT Number: NCT03558438

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Frail Older Adults Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Reina Sofia, Córdoba, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No interventions

Other

No interventions

Primary outcomes

  1. To know the prevalence of frailty in the population over 50 years old with HIV infection according to Fried's fragility phenotype

    Time frame: 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.

  2. Define a new simplified fragility index for the elderly patients with HIV infection easily applicable in clinical routine practice

    Time frame: 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

  3. To study the prognostic value of the CD4 / CD8 ratio in relation to frailty

    Time frame: Change from Basal to Year 5

  4. Analyze the relationship between exposure time to different families of antiretroviral drugs with fragility.

    Time frame: Change from Basal to Year 5

  5. Define fragility biomarkers

    Time frame: Change from Basal to Year 5

    immunological profile, oxidative damage, microbiome.

Secondary outcomes

  1. Know the functional situation and the risk of functional deterioration of the population over 50 years of age with HIV infection in our cohort

    Time frame: Year 1, year 2, year 3, year 4 and year 5

  2. Analyze the possible association of fragility in this population group with the comorbidity and the presence of other geriatric syndromes

    Time frame: Year 1, year 2, year 3, year 4 and year 5

  3. To know the prevalence of other geriatric syndromes

    Time frame: Year 1, year 2, year 3, year 4 and year 5

    polypharmacy, falls, cognitive impairment, depression, risk of malnutrition.

  4. To know the risk of fragility fractures in the population over 50 years old with HIV infection in our cohort

    Time frame: Year 1, year 2, year 3, year 4 and year 5

  5. To analyze the possible association of bone fragility with the presence of the syndrome clinical of fragility in this population group

    Time frame: Year 1, year 2, year 3, year 4 and year 5

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Registry information

Acronym: FUNCFRAIL

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2018
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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