Maroto 2005.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: Spain Dates participants recruited: NR (2‐year enrolment period) Maximum follow‐up: 10 years |
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Participants |
Inclusion criteria: male participants diagnosed with AMI and admitted to the coronary care unit; age < 65 years; low risk (hospital course without complications, absence of signs of myocardial ischaemia, functional capacity > 7 metabolic equivalent time (MET), ejection fraction > 50%, and absence of severe ventricular arrhythmias) Exclusion criteria: none described N randomised: total: 180; intervention: 90; comparator: 90 Diagnosis (% of participants): AMI: 100% Anterior: intervention: 40.0%; comparator: 48.3% Inferior/posterior: intervention: 48.3%; comparator: 46.3% Non‐Q wave: intervention: 11.6%; comparator: 5.3% Age (mean ± SD): intervention: 50.3 ± 6; comparator: 52.6 ± 9 Percentage male: 100% Ethnicity: NR |
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Interventions |
Intervention: Multidisciplinary CR programme, consisting of:
Supervised training was complemented by progressively increasing daily walks of 1 hour in duration, when participants tried to maintain the heart rate achieved during training. Walks were undertaken by participants individually and were unsupervised. Components: exercise plus psychological plus education plus return to work counselling Setting: individualised supervised programme in hospital gym Exercise programme modality: physiotherapy and aerobic training on mats or an exercise bicycle Length of session: 1‐hour sessions Frequency: 3 times per week Intensity: 75% to 85% max HR. Resistance training included? No Total duration: 3 months Co‐interventions: participants received a psychological programme including behaviour modification techniques, group therapy, and relaxation sessions, an educational programme on modifying lifestyle and controlling coronary risk factors, and return to work counselling. Comparator: participants received conventional treatment Co‐interventions: none described |
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Outcomes | Mortality, MI | |
Source of funding | NR | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The 180 patients were randomized into 2 groups”. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment is not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7/90 lost to sample in intervention group and 4/90 lost to sample in control group. |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods section are reported at all time points. |