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Completed

NCT Number: NCT05201417

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

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.

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Key information

Age range

50 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mvog Ada district Hospital, Yaoundé, Centre Region, Cameroon

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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)

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. total cholesterol ( mg/l)

    Time frame: At inclusion , up to 12 weeks and after 24 weeks

    <190mg/dl = normal and >190 mg/dl = high

  2. HDL cholesterol ( mg/dl)

    Time frame: At inclusion , up to 12 weeks and after 24 weeks

    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)

  3. Triglyceride (mg/dl)

    Time frame: At inclusion , up to 12 weeks and after 24 weeks

    Normal: <150 mg/dl, slightly elevated: 150-200mg/dl, high 200 - 500 mg/dl and very high ≥ 500 mg/dl

  4. atrial fibrillation-type heart rhythm disturbances

    Time frame: At inclusion and after 24 weeks

    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.

  5. an indirect approach to the presence of sleep apnea

    Time frame: At inclusion and after 24 weeks

    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.
  6. disturbances in the activity of the autonomic nervous system

    Time frame: At inclusion and after 24 weeks

    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
  7. inflammatry marker(Il-6)

    Time frame: At inclusion , up to 12 weeks and after 24 weeks

    nomal range 5-15 pg/ml

  8. Cystatin C (mg/l)

    Time frame: At inclusion , up to 12 weeks and after 24 weeks

    Normal : 0.48 - 0.82 (woman < 60 years) 0.54 - 0.94 (man < 60 years) and 0.63 - 1.03 (≥ 60 years)

  9. ultra sensitive CRP.

    Time frame: At inclusion , up to 12 weeks and after 24 weeks

    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)

  10. gut microbiota

    Time frame: At inclusion and after 24 weeks

    Quantification of the most important probiotics in the gut microbiota (Faecalibacterium and Eubacterium) by RT-q PCR

  11. adapted physical activity

    Time frame: 12 weeks

    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

Other outcomes

  1. Smoking

    Time frame: At inclusion

    answering "yes" to the question do you smoke?

  2. Alcoholism

    Time frame: At inclusion

    answering "yes" to the question do you consume alcohol?

  3. Body mass index

    Time frame: At inclusion

    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).

  4. Systolic Blood Pressure (mmHg)

    Time frame: At inclusion

    Systolic blood pressure ≥ 140 mmHg or taking a hypotensive treatment.

  5. Diastolic Blood Pressure (mmHg)

    Time frame: At inclusion

    diastolic ≥ 90 mmHg or taking a hypotensive treatment.

Sponsors and collaborators

Lead sponsor

Support and Education Technic Centre

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2022
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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