Trials / Unknown
UnknownNCT05832164
Effectiveness of a Multifactorial Intervention in Frailty Individuals With HIV Infection: HIDRA360
Prevalence of Frailty in Individuals With HIV Infection and Age Older Than 60 Years, Factors Associated and 6-month Effectiveness of a Multifactorial Intervention: HIDRA360
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (estimated)
- Sponsor
- Hospital Costa del Sol · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this quasi-experimental before/after study without equivalent control group is to to describe the prevalence of frail, pre-fragile and robust individuals in the study group before and after a multifactorial intervention in in frail HIV patients. The main questions it aims to answer are after a multifactorial intervention: 1. To describe the sociodemographic, viroimmunological and ART exposure factors of fragile individuals compared to pre-fragile and robust individuals. 2. To describe adherence to the Mediterranean diet in frail individuals compared to pre-frail and robust individuals. 3. To describe the presence of anxiety and depression in frail individuals with respect to pre-fragile and robust individuals. 4. To describe the analytical parameters and inflammatory markers of frail individuals with respect to pre-fragile and robust individuals. 5. To describe the diversity and composition of the intestinal microbiota of frail individuals with respect to pre-fragile and robust individuals. 6. To describe the body composition of frail individuals with respect to pre-fragile and robust individuals. 7. To describe the factors associated with progression to frailty or robustness after six months of a multifactorial intervention.
Detailed description
After the baseline visit, a multifactorial intervention will be carried out consisting of: * Distribution of short videos (10-15', in a number not exceeding 10), focused on the maintenance of a Mediterranean and balanced diet, developed by the nutrition service of our hospital. If the pandemic situation allows it, explanatory sessions will be organized with the same purpose of physical presence. * Distribution of short videos (10-15', in a number not exceeding 10) focused on the implementation and adherence to a progressive program of aerobic and anaerobic exercise, developed by the physiotherapy service of our hospital. If the pandemic situation allows it, explanatory sessions will be organized for the same purpose of physical presence. * Review of polypharmacy by the HIV Unit of our hospital. * Communication with the NGO Avance Positivo for the development of group socialization activities.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Multifactorial intervention | * Adherence to a Mediterranean diet. * Progressive aerobic and anaerobic exercise program. * Review of polypharmacy * Group socialization activities |
Timeline
- Start date
- 2022-12-15
- Primary completion
- 2023-10-31
- Completion
- 2024-01-31
- First posted
- 2023-04-27
- Last updated
- 2023-09-06
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05832164. Inclusion in this directory is not an endorsement.