Aim is to determine (cost-) effectiveness and underlying working mechanisms of a novel CR program specific for obese cardiac patients, OPTICARE-XL, in comparison with usual CR.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Health-related quality of life
Secondary outcome
Body composition, cardiometabolic risk, daily exercise, sedentary behavior,
fitness; echocardiography
Background summary
Obese cardiac patients currently participate in usual cardiac rehabilitation
(CR) programs. However, effects achieved are substantially smaller than in
non-obese patients, and non-lasting.
Study objective
Aim is to determine (cost-) effectiveness and underlying working mechanisms of
a novel CR program specific for obese cardiac patients, OPTICARE-XL, in
comparison with usual CR.
Study design
Multicenter randomized controlled trial
Intervention
*OPTICARE XL: A one-year tailor-made behavioral group intervention including
after-care, specific for obese patients, with strong focus on self-management.
Upon usual education sessions and facultative modules (stress
management/smoking cessation), OPTICARE-XL includes peer group modules on
healthy weight and active lifestyle management. Besides, the usual fitness
training is more tailored (aerobic and muscle strength training).
Or
*USUAL CARE: Usual 3-month CR group program without after-care in which both
obese and non-obese patients participate. Usual CR combines aerobic fitness
training with education sessions and facultative modules (stress
management/smoking cessation).
Study burden and risks
Both groups will receive minimally CR as recommended by the guidelines.
Subjects randomized to the OPTCARE XL will receive on top of that behavioural
therapy for healthy diet (1x/week 60 min during 12 weeks) and to stimulate an
active lifestyle (1x/3 weeks 45 minutes during 12 weeks) and a behavioural
after-care program is organized with 6 meeting (1 hour each) between weeks
13-52. Besides, the exercise program during the first 12 weeks will be more
tailored.
Independent of randomization, all participant are invited to visit the
rehabilitation center 4 times for a physical examination and to perform 2 short
fitness tests (30 min in total). Besides, patients receive 4 times a number of
questionnaires (30 min) and blood samples will be collected 4 times in a
laboratory. Furthermore, subjects will wear a small accelerometer around their
waist 4 times for 7 days during waking hours. During this period they also keep
a dairy in which they note the wear time of the accelerometer. The
questionnaires may be possible personal and / or confrontational for patients.
In addition, blood samples can result in small bruises or pain. Despite the
accelerometer is only small, wearing it can be experienced as a burden.
Patients will have no direct benefit from participating in this study.
In a subpopulation (n=50, included in the intervention or control group at
'Capri Hartrevalidation' in Rotterdam) participating in a supplementary
echocardiography study (voluntarily), two echocardiographic examinations (30-45
minutes per echo) are performed at the hospital
s-Gravendijkwal 230
Rotterdam 3015 CE
NL
s-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Obese patients (BMI>30) who are referred to cardiac rehabilitation with documented coronary artery disease (myocardial infarction [ST-segment elevation myocardial infarction; non- ST-segment elevation myocardial infarction], stable angina pectoris) or nonvalvular atrial fibrillation and who fulfill the guidelines for cardiac rehabilitation participation are included, after screening for psychopathology by a psychiatrist.
Exclusion criteria
Exclusion criteria are heart failure, left ventricle ejection fraction<40%, implantable cardioverter defibrillator, psychological or cognitive impairments which may limit cardiac rehabilitation, renal failure or other severe co-morbidity (e.g. severe chronic obstructive pulmonary disease, active malignancy, poorly controlled diabetes, intermittent claudication, musculoskeletal impairments ) which could impair participation in cardiac rehabilitation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL59297.078.16 |
OMON | NL-OMON27667 |