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Mindfulness in Cardiac Obesity Rehabilitation Using E-health

Mindfulness in Cardiac Obesity Rehabilitation Using E-health - MINDCORE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51768
Enrollment
20
Registered
2022-01-27
Start date
2022-03-29
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesitas Obesity Rehabilitation

Interventions

The intervention is a 8 week MBSR training. Weekly 2 hour sessions will be given digitally through the platform Zoom. During the sessions meditation techniques will be practiced. The sessions will b

Sponsors

Franciscus Gasthuis & Vlietland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)