Briffa 2005.
Study characteristics | ||
Methods |
Study design: multicentre open RCT (2 sites) Country: Australia Dates participants recruited: 2‐year period. No dates given. Maximum follow‐up: 1 year |
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Participants |
Inclusion criteria: uncomplicated acute myocardial infarction (AMI) or recovery from unstable angina aged under 75 years, self‐caring, adequately literate in the English language, residing in the geographical area of the health service Exclusion criteria: presentation with uncompensated heart failure, uncontrolled arrhythmias, severe and symptomatic aortic stenosis, or other conditions precluding physical activity N randomised: total: 113; intervention: 57; comparator: 56 Diagnosis (% of participants): AMI: intervention 36.8; comparator 48.2 Unstable angina: intervention 63.2; comparator 51.8 Thrombolytic therapy: intervention 14.0; comparator 25.0 PCI/CAGS: intervention 59.6; comparator 46.4 Prior AMI, PCI, CAGS: intervention 36.8; comparator 50.0 Age (Mean ± SD): intervention: 60.8 ± 8.7; comparator: 61.9 ± 9.4 Percentage male: intervention 72%; comparator 75% Ethnicity: NR |
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Interventions |
Intervention: comprehensive exercise‐based outpatient cardiac rehabilitation Components: exercise plus education plus psychosocial counselling Setting: hospital‐based, supervised exercise Exercise programme modality: aerobic circuit training interspaced with resistance training Length of session: 60 to 90 minutes Frequency: 3 times per week Intensity: NR Resistance training included? Yes Total duration: 6 weeks Co‐interventions: 45 minutes of education (12 occasions) and 45 minutes of psychosocial counselling (6 occasions). If necessary, additional one‐on‐one counselling was provided. Comparator: conventional care: participants from both groups received individualised medical treatment including non‐invasive and invasive cardiological procedures, surgical revascularisation, pharmacotherapy, and lifestyle counselling, as determined by their usual doctors. Co‐interventions: none described ("Access to community cardiac rehabilitation programs was limited for the conventional management group") |
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Outcomes | Costs, HRQoL | |
Source of funding | University of Sydney, the Cardiac Society of Australia and New Zealand, and the National Heart Foundation of Australia; NHMRC; Department of Cardiology, Royal Prince Alfred Hospital | |
Conflicts of interest | "None identified" | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "...randomisation using dynamic balancing was performed" |
Allocation concealment (selection bias) | Low risk | “Central randomisation of participants was performed at the National Health and Medical Research Council Clinical Trials Centre” |
Blinding of outcome assessment (detection bias) All outcomes | High risk | “Open” trial so we assume that outcomes were not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One person was lost to follow‐up and 5 participants changed groups; 2 participants were excluded from each group i.e. 4/113 (4%) |
Selective reporting (reporting bias) | Low risk | All outcomes described in the methods section are reported in results. |