Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group A | No Intervention | patients continue their usual HIV management no intervention | |
| intervention group B | Other | patients continue their usual HIV management, patients will benefit from an adapted physical activity program for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapted physical activity | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| heart failure | 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 | At inclusion and after 24 weeks |
| cardiovascular risks factors | 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. | At inclusion and after 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| total cholesterol ( mg/l) | <190mg/dl = normal and >190 mg/dl = high | At inclusion , up to 12 weeks and after 24 weeks |
| HDL cholesterol ( mg/dl) | Men (> 55 mg /dl = normal; 35 - 55 mg/dl = intermidiate; < 35 mg/dl = low ) women (> 65 mg/dl = normal; 45 - 65 mg/dl = intermidiate, < 45 mg/dl = low) |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking | answering "yes" to the question do you smoke? | At inclusion |
| Alcoholism | answering "yes" to the question do you consume alcohol? | At inclusion |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frédéric ROCHE, professor | 5. University Jean Monnet, St Etienne, Laboratory SNA-EPIS EA 4607, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mvog Ada district Hospital | Yaoundé | Centre Region | 588 | Cameroon | ||
| CHU Saint-Etienne |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| At inclusion , up to 12 weeks and after 24 weeks |
| Triglyceride (mg/dl) | Normal: <150 mg/dl, slightly elevated: 150-200mg/dl, high 200 - 500 mg/dl and very high ≥ 500 mg/dl | At inclusion , up to 12 weeks and after 24 weeks |
| atrial fibrillation-type heart rhythm disturbances | Atrial fibrillation occurs when action potentials fire very rapidly within the pulmonary veins or atrium in a chaotic manner. Because the atrial rate is so fast, and the action potentials produced are of such low amplitude, P waves will not be seen on the ECG in patients with atrial fibrillation. the Neurocoach is worn by the participant overnight, allowing the investigator to analyze their nightly ECG recording. | At inclusion and after 24 weeks |
| an indirect approach to the presence of sleep apnea | Heart rate allows to count sleep apnea events. Neurocoach records a 24-hour electrocardiogram (ECG). From this 24-hour recording a sleep apnea are notice throw heart rate decreases due to the stretching of mechanical receptors of the lungs. Once the ventilation resumes, heart rate increases due to the hypoxia stimuli accumulated during the apnea. These swings in heart rate allow to quantify sleep apnea. AHI (Apnea/Hypopnea Index): number of breaths stopped (apneas) or number of shallow breaths (hypopneas) per hour of sleep.
| At inclusion and after 24 weeks |
| disturbances in the activity of the autonomic nervous system | Neurocoach records a 24-hour electrocardiogram (ECG). From this 24-hour recording the variations of the RR intervals which are dependent on the innervation by the Autonomic Nervous System (ANS) which modify the RR intervals on short terms, from one interval to the other, as well as on longer terms.From the analysis of the variations of this intervals, one can deduce the activity of the ANS The parasympathetic and sympathetic variables are better separated using Fourier Transform:
| At inclusion and after 24 weeks |
| inflammatry marker(Il-6) | nomal range 5-15 pg/ml | At inclusion , up to 12 weeks and after 24 weeks |
| Cystatin C (mg/l) | Normal : 0.48 - 0.82 (woman < 60 years) 0.54 - 0.94 (man < 60 years) and 0.63 - 1.03 (≥ 60 years) | At inclusion , up to 12 weeks and after 24 weeks |
| ultra sensitive CRP. | Low risk of developing cardiovascular disease (<1.0 mg / l); Average risk of developing cardiovascular disease (1.0 to 3.0 mg / L); High risk of developing cardiovascular disease (3.0-10.0 mg / L); Other cause of inflammation (> 10.0 mg / L) | At inclusion , up to 12 weeks and after 24 weeks |
| gut microbiota | Quantification of the most important probiotics in the gut microbiota (Faecalibacterium and Eubacterium) by RT-q PCR | At inclusion and after 24 weeks |
| 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 application to get the number of steps doneand Workout duration (minute) per APA session; this data will be collected weekly | 12 weeks |
| Body mass index | 3 modalities was defined according to BMI. Underweight (BMI < 18.5 Kg/m2), normal weight (18 ≤ BMI < 25 Kg/m²), overweight (25 ≤ BMI < 30 Kg/m²), obesity (BMI ≥ 30 Kg/m²). | At inclusion |
| Systolic Blood Pressure (mmHg) | Systolic blood pressure ≥ 140 mmHg or taking a hypotensive treatment. | At inclusion |
| Diastolic Blood Pressure (mmHg) | diastolic ≥ 90 mmHg or taking a hypotensive treatment. | At inclusion |
| Saint-Etienne |
| 42000 |
| France |
| CHU Saint étienne | Saint-Etienne | France |