Effectiveness of a Multifactorial Intervention in Frailty Individuals With HIV Infection: HIDRA360

NCT ID: NCT05832164

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2024-01-31

Brief 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

Frailty Syndrome; HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Multifactorial intervention

HIV patients

Group Type: EXPERIMENTAL

Multifactorial intervention

Intervention Type: OTHER

• Adherence to a Mediterranean diet.
• Progressive aerobic and anaerobic exercise program.
• Review of polypharmacy
• Group socialization activities

Interventions

Multifactorial intervention

• Adherence to a Mediterranean diet.
• Progressive aerobic and anaerobic exercise program.
• Review of polypharmacy
• Group socialization activities

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HIV infection of at least 6 months' duration after initial diagnosis
• Ability to sign the informed consent form
• Stable residence in our health area

Exclusion Criteria

• Barthel Index<90
• Prognosis of less than one year of life at the discretion of the investigator.
• Inability to complete the study (8 months) as judged by the investigator or the patient
• Presence of Child stage C cirrhosis, end-stage renal failure (Fge by CKD-EPI<10 mL/min or dialysis in any form), dementia.
• Bone fracture within the last 3 months that interferes with gait or prehensile strength in the judgement of the investigator.
• Diagnosis prior to inclusion in the study of diseases requiring the use of chemotherapy, radiotherapy or non-minor surgery.
• End of chemotherapy or radiotherapy in the three months prior to study entry
• Major surgery in the three months prior to study entry
• Current diagnosis of wasting syndrome
• Active neoplasm at the time of study entry, except for non-melanoma skin cancer or anal carcinoma in situ

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Costa del Sol

OTHER

Sponsor Role: lead

Responsible Party

Julian Olalla Sierra

Medical Specialist, Department of Internal Medicine, Hospital Costa del Sol, Marbella (Malaga,) Spain

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Costa del Sol

Marbella, Málaga, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Damaris Aguilar Ortega

Role: primary

ensayos.medint.hcs.sspa@juntadeandalucia.es

951976542

Francisco A Tore Melendez

Role: backup

franciscoa.tore.m.sspa@juntadeandalucia.es

951976620

Other Identifiers

0368-N-22

Identifier Type: -

Identifier Source: org_study_id