Zwisler 2008.
| Methods |
Study design: Single centre RCT Country: Denmark Dates patients recruited: January 2000 to March 2003 Maximum follow up: 1 year |
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| Participants |
Inclusion criteria: Participants with congestive heart failure (12%), *ischemic heart disease (58%) or high risk of ischemic heart disease (30%). Exclusion criteria: Mental or social problems, severe illness, living in nursing home, unable to speak Danish *Total Randomised (with IHD): total: 446; intervention: 227; comparator: 219 Diagnosis (% of pts): *Ischemic heart disease: 100% Age (years): intervention: 67; comparator: 67 Percentage male: intervention: 64%; comparator: 63% Ethnicity: NR |
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| Interventions |
Intervention: A 6‐week intensive CR programme including 12 exercise training sessions. Components: exercise, education and psychosocial support. Setting: centre. Aerobic exercise: Modality: NR Length of session: NR Frequency: twice a week. Intensity: NR Resistance training included? NR Total duration: 6 weeks. Co‐interventions: Standardised CR programme which was individually tailored and carried out by a multidisciplinary team, included patient education, dietary counselling, smoking cessation, psychosocial support, risk factor management, and clinical assessment. Comparator: usual care. Co‐interventions: none described. |
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| Outcomes | Total mortality, MI, CABG, PCI, health‐related quality of life: SF‐36 at 1‐yr follow up. | |
| Source of funding | Copenhagen Hospital Corporation Research Council, Danish Heart Foundation, Danish Pharmacy Foundation of 1991, Danish Research Council, Danish Center for Evaluation and Health Technology Assessment, Denmark's Ministry of the Interior and Health, Development Fund of Copenhagen County, Villadsen Family Foundation, Eva and Henry Frænkel's Memorial Foundation, Builder LP Christensen's Foundation, Danish Animal Protection Foundation, Bristol Meyers Squibb, Merck Sharp and Dohme, AstraZeneca, The Copenhagen Trial Unit, and Bispebjerg Hospital. | |
| Conflicts of interest | NR | |
| Notes | Outcomes of interest for the IHD population were kindly provided by the authors of this study. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The Copenhagen Trial Unit computer generated the allocation sequence and provided central secretary‐staffed telephone randomization". |
| Allocation concealment (selection bias) | Low risk | "The essential patient data were registered, and the result of the randomization as delivered to the research nurse, who informed the CCR team and the patient about the allocation". |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The ... team collected secondary outcome measures blinded to intervention at baseline and without blinding at 12 months. An independent statistician analyzed the primary outcome measure blinded to intervention arm. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All IHD patients accounted for. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported at all time points. |
| Groups balanced at baseline | Low risk | “The patients were well matched at entry both overall (Table I) and in the 3 subgroups (data not shown).” |
| Intention‐to‐treat analysis conducted | Low risk | Yes. |
| Groups received same treatment (apart from the intervention) | High risk | “Comprehensive cardiac rehabilitation.....included patient education, exercise training sessions, dietary counseling, smoking cessation, psychosocial support, risk factor management, and clinical assessment". |
List of acronyms used in the Characteristics of included studies
ACS: acute coronary syndrome
AMI: acute myocardial infarction
CABG: coronary artery bypass graft
CAD: coronary artery disease
CHD: coronary heart disease
CHF: coronary heart failure
CR: cardiac rehabilitation
CV: cardiovascular
CVD: cardiovasular disease
ECG: electrocardiogram
ET: exercise training
HR: heart rate
HRQL: health related quality of life
IHD: ischemic heart disease
Kpm/min: kilopond meters per minutes
LVEF: left ventricular ejection fraction
METS: metabolic equivalents
MI: myocardial infarction
NR: not reported
PCI: percutaneous coronary intervention
PTCA: percutaneous transluminal coronary angioplasty
pts: participants
PWC: physical work capacity
RCT: randomised controlled trial
RTW: return to work
STEMI: ST segment elevation myocardial infarction
V02max: maximum oxygen uptake
WHO: World Health Organisation