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Sophrology and Congenital Heart Disease (SOPHRO CARE)

Primary Purpose

Congenital Heart Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Sophrology sessions

usual care

About this trial

This is an interventional supportive care trial for Congenital Heart Disease

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient aged 13 to 25 years old
With a congenital heart disease (CHD) as defined in the international anatomic and clinical classification (ACC) - CHD classification.
Informed consent from adult patients or parents/legal guardians for minor patients

Exclusion Criteria:

Medical contraindication to perform an exercise test.
Patient already included in a clinical trial.
Cardiac surgery planned during the study
Severe intellectual disability that does not allow practice of sophrology exercise or questionnaires to be completed .

Sites / Locations

CHU de Montpellier
Institut Saint-Pierre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Sophrology group

Control group

Arm Description

8 sophrology sessions, approximately 60 minutes each, spread over 12 months

usual care

Outcomes

Primary Outcome Measures

Maximum oxygen uptake (VO2 max)

VO2max Variation

Secondary Outcome Measures

Quality of life score

Quality of life score variation (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.

Physical activity score

Score of physical activity (Ricci and Gagnon questionnaire, 9 items, total range score from 6 to 45, higher score indicating a higher level of physical activity)

Full Information

NCT ID

NCT03999320

First Posted

June 24, 2019

Last Updated

October 2, 2023

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT03999320

Brief Title

Sophrology and Congenital Heart Disease

Acronym

SOPHRO CARE

Official Title

Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

July 19, 2019 (Actual)

Primary Completion Date

September 19, 2023 (Actual)

Study Completion Date

September 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sophrology group

Arm Type

Experimental

Arm Description

8 sophrology sessions, approximately 60 minutes each, spread over 12 months

Arm Title

Control group

Arm Type

Other

Arm Description

usual care

Intervention Type

Other

Intervention Name(s)

Sophrology sessions

Intervention Description

8 sophrology sessions, approximately 60 minutes each, spread over 12 months

Intervention Type

Other

Intervention Name(s)

usual care

Intervention Description

usual care

Primary Outcome Measure Information:

Title

Maximum oxygen uptake (VO2 max)

Description

VO2max Variation

Time Frame

Variation between Baseline (M0) and at 12 months (M12)

Secondary Outcome Measure Information:

Title

Quality of life score

Description

Quality of life score variation (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.

Time Frame

Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12

Title

Physical activity score

Description

Score of physical activity (Ricci and Gagnon questionnaire, 9 items, total range score from 6 to 45, higher score indicating a higher level of physical activity)

Time Frame

Variation between Baseline (M0) and at 12 months (M12)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient aged 13 to 25 years old With a congenital heart disease (CHD) as defined in the international anatomic and clinical classification (ACC) - CHD classification. Informed consent from adult patients or parents/legal guardians for minor patients Exclusion Criteria: Medical contraindication to perform an exercise test. Patient already included in a clinical trial. Cardiac surgery planned during the study Severe intellectual disability that does not allow practice of sophrology exercise or questionnaires to be completed .

Overall Study Officials: