Kovoor 2006.
Methods |
Study design: Multicentre RCT (2 sites) Country: Australia Dates patients recruited: NR Maximum follow up: 6 months |
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Participants |
Inclusion criteria: AMI; < 75 years of age; no angina; < 2 mm ST‐segment depression with exercise and if they attained > 7‐METS workload; left ventricular ejection fraction > 40% or no inducible ventricular tachycardia. Exclusion criteria: Patients were excluded if there was 2 mm ST‐segment depression with exercise or if 7‐METS workload was attained. N Randomised: total: 142; intervention: 70; comparator: 72 Diagnosis (% of pts): AMI: 100% Age (mean): intervention: 56.2; comparator: 55.8 Percentage male: intervention: 89%; comparator: 86% Ethnicity: NR |
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Interventions |
Intervention: Exercise (conventional treatment group): 5 week rehabilitation program consisted of exercise, education, and counselling sessions that were held 2 to 4 times per week, including work at 6 weeks after AMI. Components: Exercise, education and psychological. Setting: NR Aerobic exercise: Modality: NR Length of session: NR Frequency: 2 to 4 times per week. Intensity: NR Resistance training included? NR Total duration: 5 weeks Co‐interventions: The 2 groups of patients were encouraged to exercise at home on a regular basis. Patients were given the telephone numbers of the cardiologist and the nurse co‐ordinator so they could be contacted in case of problems. Comparator: Control group (ERNA ‐ early return to normal activities group): return to work at 2 weeks after AMI without a formal CR programme. Co‐interventions: This group of patients was contacted over the telephone by the nurse co‐ordinator once per week for 5 weeks. The 2 groups of patients were encouraged to exercise at home on a regular basis. Patients were given the telephone numbers of the cardiologist and the nurse co‐ordinator so they could be contacted in case of problems. |
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Outcomes | Total mortality; fatal/non‐fatal mortality; CABG; PCI; HRQL. Costs reported in Hall 2002 Assessment at 6 weeks and at 6 months. |
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Source of funding | National Health and Medical Research Council, Sydney, Australia. | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not described. |
Allocation concealment (selection bias) | Low risk | "Randomization schedules were generated by an independent investigator and were kept in opaque sealed envelopes." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "GHPS .... scans being analyzed in a blinded fashion by an independent nuclear medicine specialist." Blinding of other outcome assessments not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 20.4% lost to follow‐up, no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | Low risk | All outcomes reported all time points. |
Groups balanced at baseline | High risk | "At the time of randomization, there was a larger number of patients (p = 0.02) in the conventional treatment group who never adhered to a low‐cholesterol, low‐fat diet than in the ERNA group." |
Intention‐to‐treat analysis conducted | Low risk | Yes. |
Groups received same treatment (apart from the intervention) | High risk | “conventional treatment group” = 5‐week rehabilitation program which consisted of exercise, education, and counselling sessions that were held 2 to 4 times per week vs “early return to normal activities group” = return to full normal activities, including work at 2 weeks, after AMI without a formal rehabilitation programme. |