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. 2021 Nov 6;2021(11):CD001800. doi: 10.1002/14651858.CD001800.pub4

Bubnova 2020.

Study characteristics
Methods Study design: single‐centre RCT (4 arms)
Country: Russia
Dates participants recruited: NR
Maximum follow‐up: 12 months
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
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
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.