Ignite Creation Date:
2024-05-06 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05201417
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-10-31
Brief Title:
Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIVComparative Study
Sponsor:
Support and Education Technic Centre
Organization:
Support and Education Technic Centre
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None