Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV:Comparative Study
Primary Purpose
Cardiovasculars Risk Factors, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
adapted physical activity
Sponsored by

About this trial
This is an interventional health services research trial for Cardiovasculars Risk Factors focused on measuring adapted physical activity, cardiovascular diseases, Elderly, HIV, Prevention
Eligibility Criteria
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).
Sites / Locations
- Mvog Ada district Hospital
- CHU Saint-Etienne
- CHU Saint étienne
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
control group A
intervention group B
Arm Description
patients continue their usual HIV management no intervention
patients continue their usual HIV management, patients will benefit from an adapted physical activity program for 12 weeks
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
total cholesterol ( mg/l)
<190mg/dl = normal and >190 mg/dl = high
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)
Triglyceride (mg/dl)
Normal: <150 mg/dl, slightly elevated: 150-200mg/dl, high 200 - 500 mg/dl and very high ≥ 500 mg/dl
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.
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.
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
inflammatry marker(Il-6)
nomal range 5-15 pg/ml
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)
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)
gut microbiota
Quantification of the most important probiotics in the gut microbiota (Faecalibacterium and Eubacterium) by RT-q PCR
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
Full Information
NCT ID
NCT05201417
First Posted
October 31, 2021
Last Updated
January 7, 2022
Sponsor
Support and Education Technic Centre
1. Study Identification
Unique Protocol Identification Number
NCT05201417
Brief Title
Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV:Comparative Study
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
June 6, 2020 (Actual)
Study Completion Date
June 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Support and Education Technic Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovasculars Risk Factors, Heart Failure
Keywords
adapted physical activity, cardiovascular diseases, Elderly, HIV, Prevention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group A
Arm Type
No Intervention
Arm Description
patients continue their usual HIV management no intervention
Arm Title
intervention group B
Arm Type
Other
Arm Description
patients continue their usual HIV management, patients will benefit from an adapted physical activity program for 12 weeks
Intervention Type
Other
Intervention Name(s)
adapted physical activity
Intervention Description
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)
Primary Outcome Measure Information:
Title
heart failure
Description
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
Time Frame
At inclusion and after 24 weeks
Title
cardiovascular risks factors
Description
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.
Time Frame
At inclusion and after 24 weeks
Secondary Outcome Measure Information:
Title
total cholesterol ( mg/l)
Description
<190mg/dl = normal and >190 mg/dl = high
Time Frame
At inclusion , up to 12 weeks and after 24 weeks
Title
HDL cholesterol ( mg/dl)
Description
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)
Time Frame
At inclusion , up to 12 weeks and after 24 weeks
Title
Triglyceride (mg/dl)
Description
Normal: <150 mg/dl, slightly elevated: 150-200mg/dl, high 200 - 500 mg/dl and very high ≥ 500 mg/dl
Time Frame
At inclusion , up to 12 weeks and after 24 weeks
Title
atrial fibrillation-type heart rhythm disturbances
Description
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.
Time Frame
At inclusion and after 24 weeks
Title
an indirect approach to the presence of sleep apnea
Description
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.
Time Frame
At inclusion and after 24 weeks
Title
disturbances in the activity of the autonomic nervous system
Description
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
Time Frame
At inclusion and after 24 weeks
Title
inflammatry marker(Il-6)
Description
nomal range 5-15 pg/ml
Time Frame
At inclusion , up to 12 weeks and after 24 weeks
Title
Cystatin C (mg/l)
Description
Normal : 0.48 - 0.82 (woman < 60 years) 0.54 - 0.94 (man < 60 years) and 0.63 - 1.03 (≥ 60 years)
Time Frame
At inclusion , up to 12 weeks and after 24 weeks
Title
ultra sensitive CRP.
Description
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)
Time Frame
At inclusion , up to 12 weeks and after 24 weeks
Title
gut microbiota
Description
Quantification of the most important probiotics in the gut microbiota (Faecalibacterium and Eubacterium) by RT-q PCR
Time Frame
At inclusion and after 24 weeks
Title
adapted physical activity
Description
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
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Smoking
Description
answering "yes" to the question do you smoke?
Time Frame
At inclusion
Title
Alcoholism
Description
answering "yes" to the question do you consume alcohol?
Time Frame
At inclusion
Title
Body mass index
Description
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).
Time Frame
At inclusion
Title
Systolic Blood Pressure (mmHg)
Description
Systolic blood pressure ≥ 140 mmHg or taking a hypotensive treatment.
Time Frame
At inclusion
Title
Diastolic Blood Pressure (mmHg)
Description
diastolic ≥ 90 mmHg or taking a hypotensive treatment.
Time Frame
At inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ROCHE, professor
Organizational Affiliation
5. University Jean Monnet, St Etienne, Laboratory SNA-EPIS EA 4607, France
Official's Role
Study Chair
Facility Information:
Facility Name
Mvog Ada district Hospital
City
Yaoundé
State/Province
Centre
ZIP/Postal Code
588
Country
Cameroon
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France
Facility Name
CHU Saint étienne
City
Saint-Étienne
Country
France
12. IPD Sharing Statement
Learn more about this trial
Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV:Comparative Study
We'll reach out to this number within 24 hrs