Primary Objective: To determine the feasibility and protocol implementation of a specially designed MBSR training in CR for obese patients.Secondary Objective(s): 1) To explore the potential effect of MBSR on kinesiophobia in obese patients who areā¦
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
- Lifestyle issues
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The number of cardiac patients with obesity is rising, however, their number of
referral to cardiac rehabilitation (CR) is not. Obesity is a complex,
multifactorial disease that should be viewed as a heterogeneous problem. Obese
patients report a higher level of anxiety, a greater fear of movement after a
cardiac event, a poor relationship with food and frequently a negative body and
self-image. These challenges and behavioural patterns could be the obstacle for
obese patients in obtaining and maintaining a healthy lifestyle after
completing the regular CR program after a cardiac event. Mindfulness Based
Stress Reduction (MBSR) training is a promising treatment that has not been
investigated in this population. MBSR is an 8-week evidence-based group program
that employs mindfulness meditation, breathing exercises, body awareness, and
exploration of patterns of behaviour. MBSR could support cardiac obese patients
in improving their lifestyle decisions. By exploring patterns of fear and
anxiety, increasing awareness and friendliness towards oneself through guided
mindful exercises, cardiac obese patients could be offered the tools that are
needed to maintain a healthy lifestyle in the long-term.
Study objective
Primary Objective: To determine the feasibility and protocol implementation of
a specially designed MBSR training in CR for obese patients.
Secondary Objective(s):
1) To explore the potential effect of MBSR on kinesiophobia in obese patients
who are referred to CR.
2) To explore the possible effect of MBSR on eating behaviour in obese patients
referred to CR.
3) To explore whether MBSR in obese patients referred to CR leads to an
improvement in HRV.
Study design
The mindfulness CR study is an investigator driven observational, exploratory
pilot study to assess the feasibility of a specially designed MBSR training for
obese patients attending CR.
In a period of 4 months, a total of 20 patients will be prospectively recruited
for participation at locations of *Capri Hartrevalidatie* in Rotterdam and The
Hague. The program for obese patients, OPTICARE-XL, consists of different
phases, including exercise training, lifestyle counselling, dietary
counselling, risk factor control and patient education and can include a
stress-management program as well. The MBSR training will be offered as an
additive after the regular supervised CR program is completed. It will be given
in a group format and will be designed for obese patients with a focus on fear
of movement and mindful eating. Training will be given online through Zoom once
a week for a total of 8 weeks. The duration of each training will be 2 hours.
The MBSR training will be given by a certified MBSR trainer with experience in
healthcare. During the weekly training, mindfulness exercises will be practiced
and discussed with the group. Participants will receive a specially designed
workbook with information and exercises to do at home in between the training
sessions. All patients will receive a smartwatch (CardioWatch, Corsano) to wear
for the duration of 8 weeks during the MBSR training and one month after
completing MBSR to track changes in steps per day, heart rate, and heart rate
variability (HRV). Patients will receive questionnaires at baseline, after
completion of MBSR, and at 1-, 3- and 6-month follow-up.
Intervention
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 be given by a certified
mindfulness trainer. The participants will receive the MBSR workbook which
contains exercises and additional information for each session. Participants
will be asked to practice meditation at home in between the weekly sessions.
Study burden and risks
For this study, patients will receive an 8-week MBSR training and will have to
fill out questionnaires and wear a bracelet to monitor their physical activity
and heart rate. The MBSR training and questionnaires can be time consuming, but
do not imply any risk for the patient. The MBSR training that will be offered
can be of benefit for the patients, as it helps to deal with stressful and
negative thoughts and feelings and can help improve and maintain a healthy
lifestyle for obesity patients after a cardiac event. With the rising
prevalence of obesity and subsequent cardiac disease and referral to CR, the
risk to and burden for the subjects will be in proportion to the potential
benefit for the patient and value of this research.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
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
- Non-Dutch speaking participant.
- Incapable of understanding and utilizing digital communication.
- Severe psychological or cognitive impairment that limit participation in
group interventions.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL79733.100.21 |