Sophrology and Congenital Heart Disease

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    200
  • sponsor
    University Hospital, Montpellier
Updated on 6 October 2021

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.

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.

Details
Condition Congenital Heart Disease
Treatment Usual Care, Sophrology sessions
Clinical Study IdentifierNCT03999320
SponsorUniversity Hospital, Montpellier
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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