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

NCT05201417 | Completed DMC

• 1 other identifier: UJM_UB_01
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cardiovasculars Risk Factors; Heart Failure

Keywords

adapted physical activity; cardiovascular diseases; Elderly; HIV; Prevention

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• total cholesterol ( mg/l)

  At inclusion , up to 12 weeks and after 24 weeks

• HDL cholesterol ( mg/dl)

  At inclusion , up to 12 weeks and after 24 weeks

• Triglyceride (mg/dl)

  At inclusion , up to 12 weeks and after 24 weeks

• atrial fibrillation-type heart rhythm disturbances

  At inclusion and after 24 weeks

• an indirect approach to the presence of sleep apnea

  At inclusion and after 24 weeks

Other Outcomes (5)

• Smoking

  At inclusion

• Alcoholism

  At inclusion

• Body mass index

  At inclusion

Study Arms (2)

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

Other: adapted physical activity

Interventions

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)

intervention group B

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Support and Education Technic Centre: lead

Study Sites (3)

Mvog Ada district Hospital

Yaoundé, Centre Region, 588, Cameroon

Location

CHU Saint-Etienne

Saint-Etienne, 42000, France

Location

CHU Saint étienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Frédéric ROCHE, professor

  5. University Jean Monnet, St Etienne, Laboratory SNA-EPIS EA 4607, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: January 21, 2022
• Study Start: September 15, 2019
• Primary Completion: June 6, 2020
• Study Completion: June 8, 2020
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

CA (1); FR (2)