Congenital Heart DiseaseSOPHRO CARENCT03999320
Sophrology and Congenital Heart Disease
A study testing Sophrology sessions in people with Congenital Heart Disease, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Sophrology sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jul 2019to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 .
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier
Montpellier, Occitanie, 34095
Institut Saint-Pierre
Palavas-les-Flots, 34250
About this study
Official title: Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Sophrology sessions, usual care
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sophrology sessionsOther
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
usual careOther
usual care
| Study group | Role | What they receive |
|---|---|---|
| Sophrology group | Experimental | 8 sophrology sessions, approximately 60 minutes each, spread over 12 months Receives: Other: Sophrology sessions |
| Control group | Other | usual care Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen uptake (VO2 max)
VO2max Variation
Measured: Variation between Baseline (M0) and at 12 months (M12)
Secondary outcomes (2)
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.
Measured: Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12
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)
Measured: Variation between Baseline (M0) and at 12 months (M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start19 Jul 2019
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD, Principal investigator, UH MontpellierSophie GUILLAUMONT, MD, Principal investigator, Saint Pierre InstitutYves DULAC, MD, Principal investigator, UH ToulouseDamien BONNET, MD, Principal investigator, APHP NeckerAlban Louen BARUTEAU, Professor, Principal investigator, UH Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999320
- Sponsor's protocol ID
- RECHMPL18_0043
- Other IDs
- UF7590
- Acronym
- SOPHRO CARE
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2019
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32154361Moreau J, Neyraud C, Huguet H, Andrianoely M, Romieu H, Charbonnier F, Guillaumont S, De La Villeon G, Vincenti M, Requirand A, Auer A, Dulac Y, Guitarte A, Acar P, Bajolle F, Bonnet D, Chabaneix J, Iriart X, Thambo JB, Le Gloan L, Hauet Q, Venna A, Cadene A, Picot MC, Duflos C, Amedro P. Remote Sophrology in Congenital Heart Disease: The SOPHROCARE Randomized Controlled Trial. Eur J Cardiovasc Nurs. 2026 Apr 29:zvag115. doi: 10.1093/eurjcn/zvag115. Online ahead of print.
PubMed 42052946
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03999320
- Acronym / sponsor ID
- SOPHRO CARE / RECHMPL18_0043
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sophrology group | Experimental | Other: Sophrology sessions8 sophrology sessions, approximately 60 minutes each, spread over 12 months |
| Control group | Other | Other: usual careusual care |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sophrology sessions8 sophrology sessions, approximately 60 minutes each, spread over 12 months | Other | Sophrology group |
| usual careusual care | Other | Control group |
Primary outcome
Maximum oxygen uptake (VO2 max)
Time frame: Variation between Baseline (M0) and at 12 months (M12)
VO2max Variation
2 secondary outcomes
Quality of life score
Time frame: Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12
Physical activity score
Time frame: Variation between Baseline (M0) and at 12 months (M12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 32154361Moreau 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.
- Derived from this study: PubMed 42052946Moreau J, Neyraud C, Huguet H, Andrianoely M, Romieu H, Charbonnier F, Guillaumont S, De La Villeon G, Vincenti M, Requirand A, Auer A, Dulac Y, Guitarte A, Acar P, Bajolle F, Bonnet D, Chabaneix J, Iriart X, Thambo JB, Le Gloan L, Hauet Q, Venna A, Cadene A, Picot MC, Duflos C, Amedro P. Remote Sophrology in Congenital Heart Disease: The SOPHROCARE Randomized Controlled Trial. Eur J Cardiovasc Nurs. 2026 Apr 29:zvag115. doi: 10.1093/eurjcn/zvag115. Online ahead of print.
- Impact of Sophrology on cardiopulmonary fitness in teenagers andLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal AMEDRO, MD principal investigator
UH Montpellier
Sophie GUILLAUMONT, MD principal investigator
Saint Pierre Institut
Yves DULAC, MD principal investigator
UH Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sophrology sessions in people with Congenital Heart Disease, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum oxygen uptake (VO2 max) (time frame: Variation between Baseline (M0) and at 12 months (M12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03999320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.