Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03999320
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2019-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sophrology and Congenital Heart Disease
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-10
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:
SOPHRO CARE
Brief Summary:
The SOPHRO-CARE trial aims to measure the impact of sophrology on exercise capacity of adolescents and young adults with congenital heart disease.
Investigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.
Investigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.
Detailed Description:
Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity compared to the general population.
Our recent randomized trial in a population of children and adolescents with asthma showed that sophrology improve lung function (NCT02114398). Sophrology, from the Greek "study of consciousness in harmony", is an adjuvant therapy, considered in healthcare as a relaxation technique, mainly based on breathing.
Investigator assume that adolescents and young adults (13-25 y.o.) with CHD who participate in a program of sophrology with structured group sessions will improve their exercise capacity as measured by the maximum oxygen uptake (VO2max), in comparison with a control group.
Our recent randomized trial in a population of children and adolescents with asthma showed that sophrology improve lung function (NCT02114398). Sophrology, from the Greek "study of consciousness in harmony", is an adjuvant therapy, considered in healthcare as a relaxation technique, mainly based on breathing.
Investigator assume that adolescents and young adults (13-25 y.o.) with CHD who participate in a program of sophrology with structured group sessions will improve their exercise capacity as measured by the maximum oxygen uptake (VO2max), in comparison with a control group.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UF7590 | OTHER | UH Montpellier | View |