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Completed

NCT Number: NCT03999320

Sophrology and Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier, Montpellier, Occitanie, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Sophrology sessions

Other

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

Usual Care

Other

usual care

Primary outcomes

  1. Maximum oxygen uptake (VO2 max)

    Time frame: Variation between Baseline (M0) and at 12 months (M12)

    VO2max Variation

Secondary outcomes

  1. Quality of life score

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

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

  2. Physical activity score

    Time frame: Variation between Baseline (M0) and at 12 months (M12)

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: SOPHRO CARE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2019
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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