免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Sophrology and Congenital Heart Disease (SOPHRO CARE)
Sophrology and Congenital Heart Disease (SOPHRO CARE)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Heart Disease | Other: Sophrology sessions Other: usual care | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial |
| Actual Study Start Date : | July 19, 2019 |
| Estimated Primary Completion Date : | August 1, 2022 |
| Estimated Study Completion Date : | August 1, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Sophrology group
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
|
Other: Sophrology sessions
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
|
|
Control group
usual care
|
Other: usual care
usual care
|
Outcome Measures
Primary Outcome Measures :
- Maximum oxygen uptake (VO2 max) [ Time Frame: Variation between Baseline (M0) and at 12 months (M12) ]VO2max Variation
Secondary Outcome Measures :
- 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.
- 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)
Eligibility Criteria
| Ages Eligible for Study: | 13 Years to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 .
Contacts and Locations
Contacts
| Contact: Pascal AMEDRO, MD | 0467336632 | p-amedro@chu-montpellier.fr | |
| Contact: Huguette ROMIEU | huguette.romieu@wanadoo.fr |
Locations
| France | |
| CHU Arnaud de Villeneuve | Recruiting |
| Montpellier, Occitanie, France, 34090 | |
| Contact: Pascal AMEDRO, PhD +33 (0) 4 67 33 66 39 p-amedro@chu-montpellier.fr | |
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
| Principal Investigator: | 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 |
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 24, 2019 | ||||||||||||
| First Posted Date ICMJE | June 26, 2019 | ||||||||||||
| Last Update Posted Date | December 3, 2020 | ||||||||||||
| Actual Study Start Date ICMJE | July 19, 2019 | ||||||||||||
| Estimated Primary Completion Date | August 1, 2022 (Final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Maximum oxygen uptake (VO2 max) [ Time Frame: Variation between Baseline (M0) and at 12 months (M12) ] VO2max Variation
|
||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | |||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Sophrology and Congenital Heart Disease | ||||||||||||
| Official Title ICMJE | Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial | ||||||||||||
| 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. |
||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
||||||||||||
| Condition ICMJE | Congenital Heart Disease | ||||||||||||
| Intervention ICMJE |
|
||||||||||||
| Study Arms ICMJE |
|
||||||||||||
| 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. | ||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
| Estimated Study Completion Date ICMJE | August 1, 2023 | ||||||||||||
| Estimated Primary Completion Date | August 1, 2022 (Final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Sex/Gender ICMJE |
|
||||||||||||
| Ages ICMJE | 13 Years to 25 Years (Child, Adult) | ||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||
| Contacts ICMJE |
|
||||||||||||
| Listed Location Countries ICMJE | France | ||||||||||||
| Removed Location Countries | |||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT03999320 | ||||||||||||
| Other Study ID Numbers ICMJE | RECHMPL18_0043 UF7590 ( Other Identifier: UH Montpellier ) |
||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| U.S. FDA-regulated Product |
|
||||||||||||
| IPD Sharing Statement ICMJE |
|
||||||||||||
| Responsible Party | University Hospital, Montpellier | ||||||||||||
| Study Sponsor ICMJE | University Hospital, Montpellier | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
|
||||||||||||
| PRS Account | University Hospital, Montpellier | ||||||||||||
| Verification Date | December 2020 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||
