Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV:Comparative Study
Condition: Cardiovasculars Risk Factors; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

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.
    

Intervention name(s): adapted physical activity
Intervention type(s): Other
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: adapted physical activity; cardiovascular diseases; Elderly; HIV; Prevention