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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 112
- Locations
- 6
- Primary Endpoint
- cardiovascular risks factors
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 77 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
cardiovascular risks factors
Time Frame: At inclusion and after 24 weeks
evaluated by summing the participant's cardiovascular risk factors. The cardiovascular risk factors assess were metabolic disorders(Total cholesterol, HDL cholesterol, Triglyceride), smoking, physical inactivity, alcohol consumption (defined by an AUDIT score ≥ 8), overweight or obesity, hypertension, and diabetes. The cardiovascular risk was considered high if the subject had a combination of at least 3 cardiovascular risk factors.
heart failure
Time Frame: At inclusion and after 24 weeks
evaluated by summing the participant's factors contributing to heart rate variability. The Neurocoach records a 24-hour electrocardiogram (ECG). From this 24-hour recording, 3 types of variable are given, cardiac arrhythmias, Autonomic nervous system (ANS) activity, Sleep apnea parameters. the punctual analysis of the neurocoach recording makes it possible to highlight atrial fibrillation (AF) and sleep apnea, factors known to promote the risk of a cardiovascular accident
Secondary Outcomes
- ultra sensitive CRP.(At inclusion , up to 12 weeks and after 24 weeks)
- total cholesterol ( mg/l)(At inclusion , up to 12 weeks and after 24 weeks)
- Triglyceride (mg/dl)(At inclusion , up to 12 weeks and after 24 weeks)
- atrial fibrillation-type heart rhythm disturbances(At inclusion and after 24 weeks)
- disturbances in the activity of the autonomic nervous system(At inclusion and after 24 weeks)
- adapted physical activity(12 weeks)
- HDL cholesterol ( mg/dl)(At inclusion , up to 12 weeks and after 24 weeks)
- Cystatin C (mg/l)(At inclusion , up to 12 weeks and after 24 weeks)
- an indirect approach to the presence of sleep apnea(At inclusion and after 24 weeks)
- inflammatry marker(Il-6)(At inclusion , up to 12 weeks and after 24 weeks)
- gut microbiota(At inclusion and after 24 weeks)
Investigators
Bienvenu BONGUE
principal investigator
Support and Education Technic Centre