Cardiovasculars Risk FactorsNCT05201417
Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV:Comparative Study
A study testing adapted physical activity in people with Cardiovasculars Risk Factors and Heart Failure, run by Support and Education Technic Centre at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 50 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovasculars Risk Factors, Heart Failure
- What is being tested?
- adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Sep 2019to 8 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
CHU Saint-Etienne
Saint-Etienne, 42000
CHU Saint étienne
Saint-Etienne
About this 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.
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.
Read the 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.
- Conditions
- Cardiovasculars Risk Factors, Heart Failure
- Being tested
- adapted physical activity
- Keywords
- adapted physical activity, cardiovascular diseases, Elderly, HIV, Prevention
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted physical activityOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At inclusion and after 24 weeks
Secondary outcomes (11)
total cholesterol ( mg/l)
<190mg/dl = normal and >190 mg/dl = high
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
- From 5 to 15 ...... Mild Sleep Apnoea Syndrome
- 15 to 30 .... Moderate Sleep Apnoea Syndrome
- More than 30 ..... Severe Sleep Apnoea Syndrome.
Measured: 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:
- 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
Measured: At inclusion and after 24 weeks
inflammatry marker(Il-6)
nomal range 5-15 pg/ml
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Sep 2019
- Primary completion6 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovasculars Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Support and Education Technic Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bienvenu BONGUE, Support and Education Technic Centre
- Investigators
- Frédéric ROCHE, professor, Study chair, 5. University Jean Monnet, St Etienne, Laboratory SNA-EPIS EA 4607, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201417
- Sponsor's protocol ID
- UJM_UB_01
- Status last verified
- Jan 2022
- First submitted
- 31 Oct 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05201417
- Acronym / sponsor ID
- UJM_UB_01
- Conditions
- Cardiovasculars Risk Factors, Heart Failure
- Keywords
- adapted physical activity, cardiovascular diseases, Elderly, HIV, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Support and Education Technic CentreUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group A | No intervention | –patients continue their usual HIV management no intervention |
| intervention group B | Other | Other: adapted physical activitypatients continue their usual HIV management, patients will benefit from an adapted physical activity program for 12 weeks |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapted physical activityThe 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) | Other | intervention group B |
Primary outcome
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
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.
11 secondary outcomes
total cholesterol ( mg/l)
Time frame: At inclusion , up to 12 weeks and after 24 weeks
HDL cholesterol ( mg/dl)
Time frame: At inclusion , up to 12 weeks and after 24 weeks
Triglyceride (mg/dl)
Time frame: At inclusion , up to 12 weeks and after 24 weeks
atrial fibrillation-type heart rhythm disturbances
Time frame: At inclusion and after 24 weeks
an indirect approach to the presence of sleep apnea
Time frame: At inclusion and after 24 weeks
disturbances in the activity of the autonomic nervous system
Time frame: At inclusion and after 24 weeks
inflammatry marker(Il-6)
Time frame: At inclusion , up to 12 weeks and after 24 weeks
Cystatin C (mg/l)
Time frame: At inclusion , up to 12 weeks and after 24 weeks
ultra sensitive CRP.
Time frame: At inclusion , up to 12 weeks and after 24 weeks
gut microbiota
Time frame: At inclusion and after 24 weeks
adapted physical activity
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric ROCHE, professor study chair
5. University Jean Monnet, St Etienne, Laboratory SNA-EPIS EA 4607, France
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity in people with Cardiovasculars Risk Factors and Heart Failure, run by Support and Education Technic Centre at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart failure (time frame: At inclusion and after 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.