NCT03999320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

July 19, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2023

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

4.2 years

First QC Date

June 24, 2019

Last Update Submit

October 2, 2023

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen uptake (VO2 max)

    VO2max Variation

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

Secondary Outcomes (2)

  • Quality of life score

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

  • Physical activity score

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

Study Arms (2)

Sophrology group

EXPERIMENTAL

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

Other: Sophrology sessions

Control group

OTHER

usual care

Other: usual care

Interventions

Sophrology sessionsOTHER

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

Sophrology group
usual careOTHER

usual care

Control group

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Montpellier

Montpellier, Occitanie, 34095, France

Location

Institut Saint-Pierre

Palavas-les-Flots, 34250, France

Location

Related Publications (1)

  • Moreau J, Lavastre K, Romieu H, Charbonnier F, Guillaumont S, Bredy C, Abassi H, Werner O, De La Villeon G, Requirand A, Auer A, Matecki S, Karsenty C, Guitarte A, Hadeed K, Dulac Y, Souletie N, Acar P, Bajolle F, Bonnet D, Negre-Pages L, Mura T, Mounier M, Seguela PE, Thomas J, Iriart X, Jean-Benoit-Thambo, Amedro P. Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods. Int J Cardiol Heart Vasc. 2020 Mar 3;27:100489. doi: 10.1016/j.ijcha.2020.100489. eCollection 2020 Apr.

    PMID: 32154361BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Pascal AMEDRO, MD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

  • Sophie GUILLAUMONT, MD

    Saint Pierre Institut

    PRINCIPAL INVESTIGATOR

  • Yves DULAC, MD

    UH Toulouse

    PRINCIPAL INVESTIGATOR

  • Damien BONNET, MD

    APHP Necker

    PRINCIPAL INVESTIGATOR

  • Alban Louen BARUTEAU, Professor

    UH Nantes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 26, 2019

Study Start

July 19, 2019

Primary Completion

September 19, 2023

Study Completion

September 19, 2023

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)