obesitas Obesity Rehabilitation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Obese patients with a BMI of >= 30 who are referred to CR with documented coronary artery disease (CAD) (myocardial infarction [ST-segment elevation myocardial infarction; non- ST-segment elevation myocardial infarction], unstable angina pectoris, chronic coronary syndrome) or nonvalvular AF and who fulfill the guidelines for CR participation
Exclusion criteria
Exclusion criteria: - Non-Dutch speaking participant. - Incapable of understanding and utilizing digital communication. - Severe psychological or cognitive impairment that limit participation in group interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the feasibility of MBSR training in CR in obese patients. Several parameters will be collected to study the feasibility. - Number of eligible patients - The proportion of patients that is willing to participate in MBSR training - The proportion of patients that attend all 8 courses and complete MBSR training - Inclusion rate per month - Response rate to questionnaores - Compliance rate - Overall contentment of the MBSR training. Participants will be asked to rate their answers to this question on a5-point scale from 'strongly disagree' to ' strongly agree' | — |
Secondary
| Measure | Time frame |
|---|---|
| To explore the potential effect of MBSR training on kinesiophobia, participants will be asked to complete the TSK-NL Heart questionnaire before start of the training and after completing of the training. The TSK-NL Heart questionnaire is developed to measure kinesiophobia in cardiac patients. In order to investigate the effect of mindful eating, participants will complete the Mindfulness Eating Behaviour Questionnaire (MEBS). The MEBS is a validated questionnaire that focuses on the physical sensation and emotion while eating or in a food-related environment. It is a 17-item self-report instrument that focuses on five mindful eating domains: awareness, disinhibition, distraction, emotional response, and external cues. The results of the MEBS will be used to explore whether MBSR has a potential effect on eating patterns in obesity. In order to explore the effect on MBSR training on the participants, the Five Facet Mindfulness Questionnaire (FFMQ) will be completed.The FFMQ is a validated and self-scorable measurement on the five facets of mindfulness: observation, description, aware actions, non-judgemental inner experience, and non-reactivity. The test consists of 39 items that measure these five facets and the score provides an estimate on where participants stand in terms of mindfulness and self-awareness. All participants will be asked to wear a bracelet, Corsano CardioWatch during the 8 weeks of MBSR training and up until one month after completing the MBSR, in order to monitor the possible effect of MBSR on HRV and steps per day. The bracelet detects the heart rate, rhythm, and HRV using photoplethysmogram (PPG) sensor. The Corsano CardioWatch is expected to receive CE Class IIa certification in December 2021. Details about the Corsano CaridioWatch are provided in the IMDD. | — |
Countries
Netherlands