Clinical trial NCT05201417: Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV:Comparative Study
Official title: Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV: Comparative Study of Two Cohortes, CHU Saint Etienne (France) and Mvog Ada District Hospital Yaoundé, Cameroon.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovasculars Risk Factors
Heart Failure
Keywords: adapted physical activity
cardiovascular diseases
Elderly
HIV
Prevention
Lead sponsor: Support and Education Technic Centre
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A quasi-experimental and comparative study will be conducted in two different geographical areas (Europe-France and Africa-Cameroon) on a period of 18 months. All eligible adults aged 50 years and older presenting to one of the investigative centers (for HIV care) will be included in the study. The patients will be randomized in two parallel groups according to the 1:1 ratio, namely a control group A where patients continue the usual HIV management, and an intervention group B where in addition to the usual HIV management, patients will benefit from an adapted physical activity (APA) program for three months. An evaluation of heart rate variability, response to current treatment, gut microbiota profile and quality of life will be performed at the end of the APA session. Comparison between control group A and intervention group B will be performed. The acceptability of this program will also be evaluated.

Detailed description: Purpose: The objective of our study was to measure the effect of a physical activity training program on heart rate variability (ANS) in PLWHIV in 2 different geographical areas (Europe-France and Africa-Cameroon). Investigators also propose to measure the impact of this program on inflammation markers such as IL-6, ultra-sensitive CRP and Cystatin C, on the quality of the microbiota of PLHIV and TMAO.

participants and methods: Investigators will conduct a comparative study that involved subjects aged from 50 years and above, recruited from June 2019 to June 2020 at Mvog Ada district hospital

This study will be conducted in 3 phases:

* Phase 1: All eligible adults aged 50 years and older presenting to one of the investigative centers (for HIV care) will be included in the study. The standardized program of adapted physical activity is proposed on the basis of the specifications of adapted physical activities. The participants will be randomized in two parallel groups according to the 1:1 ratio, namely a control group A where participants continue their usual HIV management, and an intervention group B where in addition to the usual HIV management, participants will benefit from an adapted physical activity program. Information regarding heart rate variability and ANS dysfunction will be collected via an overnight recording with the NeuroCoach device (recording box). A questionnaire (to determine the level of physical activity, on compliance with current treatment and quality of life) will be administered.
* Second phase: intervention phase The adapted physical activity program will be offered systematically to all participants in group B. The standardized program of adapted physical activity is proposed on the basis of the specifications of adapted physical activities. An evaluation of heart rate variability, response to current treatment, gut microbiota profile and quality of life will be performed at the end of the APA sessions. Comparison between control group A and intervention group B will be performed.
* The third phase: post-program follow-up: six months At the end of the intervention phase, post-program follow-up will be done through interviews until six months after the end of the intervention. All the participants included will be able to benefit, at their request, a counseling session related to the adapted physical activity program, in order to reinforce integration of physical activity into their day to day routine.

Eligibility criteria: Inclusion Criteria:

* People aged 50 to 77 years ;
* People living with HIV in one of the 2 study'countries;
* People without medical contraindications to participate in moderate physical activity
* People who has received information about the study and its rights to its data.

Exclusion Criteria:

* Patient under guardianship or curatorship;
* Having a contraindication to physical activity (medical certificate);
* Infected with HIV-2 alone;
* Hospitalized, in end of life care;
* Morbidly obese (BMI \> 40).

Primary outcomes:
measure: heart failure
timeFrame: At inclusion and after 24 weeks
measure: cardiovascular risks factors
timeFrame: At inclusion and after 24 weeks
Secondary outcomes:
measure: total cholesterol ( mg/l)
timeFrame: At inclusion , up to 12 weeks and after 24 weeks
measure: HDL cholesterol ( mg/dl)
timeFrame: At inclusion , up to 12 weeks and after 24 weeks
measure: Triglyceride (mg/dl)
timeFrame: At inclusion , up to 12 weeks and after 24 weeks
measure: atrial fibrillation-type heart rhythm disturbances
timeFrame: At inclusion and after 24 weeks
measure: an indirect approach to the presence of sleep apnea
timeFrame: At inclusion and after 24 weeks
measure: disturbances in the activity of the autonomic nervous system
timeFrame: At inclusion and after 24 weeks
measure: inflammatry marker(Il-6)
timeFrame: At inclusion , up to 12 weeks and after 24 weeks
measure: Cystatin C (mg/l)
timeFrame: At inclusion , up to 12 weeks and after 24 weeks
measure: ultra sensitive CRP.
timeFrame: At inclusion , up to 12 weeks and after 24 weeks
measure: gut microbiota
timeFrame: At inclusion and after 24 weeks
measure: adapted physical activity
timeFrame: 12 weeks
Other outcomes:
measure: Smoking
timeFrame: At inclusion
measure: Alcoholism
timeFrame: At inclusion
measure: Body mass index
timeFrame: At inclusion
measure: Systolic Blood Pressure (mmHg)
timeFrame: At inclusion
measure: Diastolic Blood Pressure (mmHg)
timeFrame: At inclusion
Locations:
city: Yaoundé
country: Cameroon
facility: Mvog Ada district Hospital
state: Centre
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Saint-Étienne
country: France
facility: CHU Saint étienne
Study officials:
affiliation: 5. University Jean Monnet, St Etienne, Laboratory SNA-EPIS EA 4607, France
name: Frédéric ROCHE, professor
role: STUDY_CHAIR
References: