Bubnova 2020.
Study characteristics | ||
Methods |
Study design: single‐centre RCT (4 arms) Country: Russia Dates participants recruited: NR Maximum follow‐up: 12 months |
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Participants |
Inclusion criteria: patients after AMI ( > 3 weeks) and percutaneous coronary interventions (PCI) at the age of < 60 years for men and < 55 years for women Exclusion criteria: inadequately controlled hypertension, aortic or left ventricular (LV) aneurysm with thrombosis, serious arrhythmias, NYHA class III‐IV HF, BMI ≥ 40 kg/m2, moderate/severe diabetes and other severe comorbidities N randomised: total: 312; intervention 1 (BMI < 30 kg/m2) = 78; intervention 2 (BMI ≥ 30 kg/m2) = 78; comparator 1 (BMI < 30 kg/m2) = 78; comparator 2 (BMI ≥ 30 kg/m2) = 78 Diagnosis (% of participants): 100% post MI with PCI Age (mean ±SD): intervention 1 (BMI < 30 kg/m2) = 51.9±7.9; intervention 2 (BMI ≥ 30 kg/m2) = 51.7±6.8; comparator 1 (BMI < 30 kg/m2) = 52.2±7.2; comparator 2 (BMI ≥ 30 kg/m2) = 52.6±6.7 Percentage male: intervention 1 (BMI < 30 kg/m2) = 93.6%; intervention 2 (BMI ≥ 30 kg/m2) = 96.2%; comparator 1 (BMI < 30 kg/m2) = 94.9%; comparator 2 (BMI ≥ 30 kg/m2) = 93.6% Ethnicity: NR |
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Interventions |
Intervention: physical rehabilitation programme included group exercise classes lasting 60 minutes 3 times/week involving a set of gymnastic exercises of moderate intensity Components: exercise only Setting: centre‐based Exercise programme modality: gymnastic exercises Length of session: 1 hour Frequency: three sessions per week Intensity: 60% of the threshold value according to cycle ergometer test Resistance training included? No Total duration: 1 year Co‐interventions: none described Comparator: control participants did not use exercise training programme Co‐interventions: none described |
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Outcomes | Mortality, MI, HRQoL | |
Source of funding | Not reported | |
Conflicts of interest | None declared | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Patients were randomised into four groups depending on BMI”. Authors provided further information: "randomly assigned to the physical training or to the control group using a computer programme". |
Allocation concealment (selection bias) | Low risk | Authors provided further information: "The allocation sequence was concealed from enrolling researcher". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided regarding blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No PRISMA flow diagram or description of attrition |
Selective reporting (reporting bias) | Unclear risk | No published protocol available, but outcomes described in methods appear to be reported. |