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A novel tailor-made cardiac rehabilitation program for obese patient with coronary artery disease.


- candidate number26488
- NTR NumberNTR6181
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jan-2017
- Secondary IDsNL59297.078.16 OPTICARE XL
- Public TitleA novel tailor-made cardiac rehabilitation program for obese patient with coronary artery disease.
- Scientific TitleOPTICARE XL: Effectiveness and cost-effectiveness of a novel tailor-made cardiac rehabilitation program for obese patients with coronary artery disease.
- ACRONYMOPTICARE XL
- hypothesisOPTICARE XL will lead to behavioral change towards a healthier lifestyle, resulting in improved health and quality of life. While the novel program requires some extra costs, OPTICARE XL is expected to be cost-effective, even with a time horizon of 1 year.
- Healt Condition(s) or Problem(s) studiedCoronary artery disease, Rehabilitation, Obesity
- Inclusion criteriaBMI >30, age >18, coronary artery disease (myocardial infarction, angina pectoris), nonvalvular atrial fibrillation, referred to cardiac rehabilitation
- Exclusion criteriaHeart failure, left ventricle ejection fraction <40%, implantable cardioverter defibrillator, psychological or cognitive impairments which may limit cardiac rehabilitation, renal failure or other severe comorbidities which could impair cardiac rehabilitation
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-jan-2017
- planned closingdate31-dec-2019
- Target number of participants200
- InterventionsOPTICARE XL: a one-year tailor-made behavioral group intervention including after-care, specific for obese CAD patients, with strong focus on self-management. Upon usual education sessions and facultative modules OPTICARE XL includes peer group modules on healthy weight and active lifestyle management, and tailored fitness training (aerobic and muscle strength). Control group receives usual cardiac rehabilitation care.
- Primary outcomeHealth-related quality of life.
- Secondary outcomebody composition (weight, height, BMI, waist circumference), blood pressure, lipid profile and glucose in Fasting blood sample, smoking status, physical activity level, aerobic fitness, muscle strength
- TimepointsIntervention: Tpre (for cardiac rehabilitation program), Tmid (after cardiac rehabilitation program), Tpost (after after-care of 9 months), TFU6 (6 months after Tpost).
Control: Tpre, Tpost (after cardiac rehabilitation program), TFU6 (6 months after Tpost), TFU15 (15 months after Tpost).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Iris den Uijl
- CONTACT for SCIENTIFIC QUERIES Iris den Uijl
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Capri Hartrevalidatie, Rotterdam
- Publications
- Brief summaryObese patients with coronary artery disease currently participate in usual cardiac rehabilitation programs. However, effects achieved are substantially smaller than in non-obese patients, and non-lasting. The OPTICARE XL study investigates a novel tailor-made cardiac rehabilitation program, especially designed for this (still increasing) patient group. Upon usual education sessions and facultative modules (stress management/smoking cessation), OPTICARE-XL has a strong focus on self-management and includes peer group modules on healthy weight and active lifestyle management, and tailored fitness training (aerobic and muscle strength training).
- Main changes (audit trail)
- RECORD16-jan-2017 - 19-feb-2017


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