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Cardiac rehabilitation is a major component of treatment for patients suffering from coronary pathology revealed by myocardial infarction or acute coronary syndrome warranting transluminal coronary angioplasty, as well as in the aftermath of cardiac surgery.
A significant proportion of patients in this situation (40%) suffer from varying degrees of anxiety and depression, which are difficult to treat. These impair their quality of life and can make it more difficult for them to take part in the rehabilitation program, compromising the results that can be expected. Finally, they are often associated with lax compliance with medical treatment, less control of risk factors and less regular exercise.
Cardiac rehabilitation teams are well aware of this anxiety-depressive picture, and various therapies such as sophrology, relaxation and yoga have been proposed as alternatives to conventional medical treatments to help patients through this period.
Among these alternatives is the concept of "Mindfulness-Based Meditation", based on the Mindfulness-Based Stress Reduction (MBSR) protocol described by Dr. JKabat Zinn.
It has been the subject of several prospective randomized studies, which have demonstrated that it is suitable for the management of patients in this situation, and that it has measurable beneficial effects on their sense of well-being.
To our knowledge, the MBSR program used in cardiac rehabilitation has never been the subject of a randomized comparative study in France to assess its effectiveness on medium- and long-term anxiety-depressive disorders. This is the objective of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) | Experimental | Conventional cardiac rehabilitation over 4 weeks with the introduction of MBSR over 8 weeks |
|
| Conventional cardiac rehabilitation | Active Comparator | Conventional cardiac rehabilitation over 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) | Other | The MBSR program is as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of HADS anxiety and depression scores | HADS (Hospital Anxiety and Depression Scale) is a self questionnaire including 14 items which identifies and quantifies the depression and anxiety from which a person suffers. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the quality of life | The patients' quality of life will be measured by the MQOL-R questionnaire, which is a 14-point tool forming 4 subscales: physical, psychological, existential and social. | Baseline, 1 month, 6 months and 12 months |
| Medical treatment compliance |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique d'Aressy | Aressy | 64320 | France |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| Conventional cardiac rehabilitation | Other | The usual cardiac rehabilitation program combines exercise training and therapeutic education workshops, with a daily session for four weeks. |
|
The patients' compliance to their medical treatment will be measured by the GIRERD self-questionnaire including 6 questions, to assess compliance, i.e. whether treatment is taken regularly and as prescribed. |
| Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "fasting blood glucose" | fasting blood glucose (in g/L) | Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "glycosylated hemoglobin" | glycosylated hemoglobin (% of total hemoglobin) | Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "Lipid profile LDLc" | Low Density Lipoprotein cholesterol (g/l)
| Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "Lipid profile HDLc" | High Density Lipoprotein cholesterol (g/l) | Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "BMI" | BMI ( weight and height will be combined to report BMI in kg/m2) | Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "effort" | 6-minute walk test | Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "activity" | Ricci Gagnon scale: self questionnaire including 9 questions to evaluate if the subject has an inactive, active or very active profile | Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "Tobacco consumption" | Tobacco consumption (in packs.year) | Baseline, 1 month, 6 months and 12 months |
| Changes from baseline of cardiac risk factor "Blood pressure measurement" | Blood pressure | Baseline, 1 month, 6 months and 12 months |
| To assess the patient's anxiety | HADS anxiety score | Baseline, 1 months and 6 months |
| To assess the patient's depression | HADS depression score | Baseline, 1 months and 6 months |
| To evaluate the continuation of formal and informal mindfulness meditation practices in patients who have benefited from the MBSR program. | Patients of the MBSR group will be asked two questions : "Do you still do formal meditation practices?" "Do you still do informal meditation practices?" | 3 months, 6 months and 12 months |
| To evaluate the patient's "mindfulness" and its impact on vital aspects in patients who have benefited from the MBSR program. | FFMQ (Five Facets Mindfulness Questionnaire) questionnaire, which includes 39 questions, which assess the 5 facets which constitute mindfulness as a construct:
| 3 months, 6 months and 12 months |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |