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

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201417
• Other study ID #: UJM_UB_01
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: June 8, 2020

Study information

• Verified date: January 2022
• Source: Support and Education Technic Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 8, 2020
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 77 Years

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Intervention

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)

Locations

Country	Name	City	State
Cameroon	Mvog Ada district Hospital	Yaoundé	Centre
France	CHU Saint étienne	Saint-Étienne
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Support and Education Technic Centre

Countries where clinical trial is conducted

Cameroon,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking	answering "yes" to the question do you smoke?	At inclusion
Other	Alcoholism	answering "yes" to the question do you consume alcohol?	At inclusion
Other	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
Other	Systolic Blood Pressure (mmHg)	Systolic blood pressure = 140 mmHg or taking a hypotensive treatment.	At inclusion
Other	Diastolic Blood Pressure (mmHg)	diastolic = 90 mmHg or taking a hypotensive treatment.	At inclusion
Primary	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
Primary	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
Secondary	total cholesterol ( mg/l)	<190mg/dl = normal and >190 mg/dl = high	At inclusion , up to 12 weeks and after 24 weeks
Secondary	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)	At inclusion , up to 12 weeks and after 24 weeks
Secondary	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
Secondary	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
Secondary	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.; From 5 to 15 ...... Mild Sleep Apnoea Syndrome; 15 to 30 .... Moderate Sleep Apnoea Syndrome; More than 30 ..... Severe Sleep Apnoea Syndrome.	At inclusion and after 24 weeks
Secondary	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: High Frequency (HF 0,15 et 0,4 Hz.) gives the parasympathetic activity; Low frequency (LF 0,04 et 0,15 Hz) gives the sympathetic activity; The LF/HF ratio gives the equilibrium between both activities Ratio < 2 .......... balanced sympathetic-vagal balance; 2 < Ratio < 4 .... slightly unbalanced sympathetic-vagal balance; 4 < Ratio < 6 .... unbalanced sympathetic-vaginal balance; 6 < Ratio .......... strongly unbalanced sympathetic-vagal balance	At inclusion and after 24 weeks
Secondary	inflammatry marker(Il-6)	nomal range 5-15 pg/ml	At inclusion , up to 12 weeks and after 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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