Rationale and design of a randomised clinical trial for an extended cardiac rehabilitation programme using telemonitoring: the TeleCaRe studyReport as inadecuate




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BMC Cardiovascular Disorders

, 16:175

Coronary artery disease

Abstract

BackgroundDespite the known positive effects of cardiac rehabilitation and an active lifestyle, evidence is emerging that it is difficult to attain and sustain the minimum recommendations of leisure time physical activity. The long-term benefits are often disappointing due to lack of adherence to the changes in life style. Qualitative research on patients’ perspectives suggests that motivation for lifestyle change tends to diminish around 3 months after the index-event. The time most cardiac rehabilitation programmes end. The aim of the present study is to determine if prolongation of a traditional cardiac rehabilitation programme with additional heart rate based telemonitoring guidance for a period of 6 months results in better long term effects on physical and mental outcomes, care consumption and quality of life than traditional follow-up.

MethodsIn this single centre randomised controlled trial 120 patients with an absolute indication for cardiac rehabilitation will be randomised in a 1:1 ratio to an intervention group with 6 months of heart rate based telemonitoring guidance or a control group with traditional follow-up after cardiac rehabilitation. The primary endpoint will be VO2peak after 12 months. Secondary endpoints are VO2peak after 6 months, quality of life, physical-, emotional- and social functioning, cardiac structure, traditional risk profile, compliance to the use of the heart rate belt and smartphone, MACE and care-consumption.

DiscussionThe TeleCaRe study will provide insight into the added value of the prolongation of traditional cardiac rehabilitation with 6 months of heart rate based telemonitoring guidance.

Trial registrationDutch Trial Register: NTR4644 registered 06-12-14.

KeywordsCardiac rehabilitation Telemonitoring and telecoaching VO2 Cardio respiratory fitness Leisure time physical activity Randomised controlled trial AbbreviationsACSAcute coronary syndrome

CABGCoronary artery bypass grafting

CPETCardio pulmonary exercise test

CRCardiac rehabilitation

CRFCardio respiratory fitness

CROContract research organisation

CVDCardiovascular diseases

GPGeneral practitioner

HADSHospital anxiety and depressions scale

HRHeart rate

HRRHeart rate recovery

ICDImplantable cardioverter defibrillator

IPAQInternational physical activity questionnaire

IVSIntra ventricular septum

LTPALeisure time physical activity

LVEDLeft ventricle at end-diastole

LVESLeft ventricle at end-systole

LVPWLeft ventricular posterior wall

MACEMajor adverse cardiac events

METMetabolic equivalent of task

MPSSMood and physical symptom scale

PCIPercutaneous coronary intervention

PHQPatient health questionnaire

QOLQuality of life

RERRespiratory exchange ratio

SAESerious adverse events

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Author: Johan A. Snoek - Esther P. Meindersma - Leonie F. Prins - Arnoud W. J. van’t Hof - Maria T. Hopman - Menko-Jan de Bo

Source: https://link.springer.com/



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