NCT05201417

Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV:Comparative Study

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Support and Education Technic Centre · Academic / Other
• Sex: All
• Age: 50 Years – 77 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovasculars Risk Factors
• Heart Failure

Interventions

Type	Name	Description
OTHER	adapted physical activity	The adapted physical activity will be administered remotely through the whatsApp or YouTube application. Two sessions will be done per week: Wednesday and Sunday. Walking seems to be appropriate for all participants We will account for 24 APA sessions. We will leverage the Step Tracker phone app and pedometer to get the number of steps done, number of calories spent, Workout duration and distance walked per participant per APA session; this data will be collected weekly (after every two sessions)

Timeline

• Start date: 2019-09-15
• Primary completion: 2020-06-06
• Completion: 2020-06-08
• First posted: 2022-01-21
• Last updated: 2022-01-21

Locations

3 sites across 2 countries: Cameroon, France