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

Bubnova 2019.

Study characteristics
Methods Study design: single‐centre RCT
Country: Russia
Dates participants recruited: NR
Maximum follow‐up: 12 months.
Participants Inclusion criteria: male and female participants of working age (male < 60 years, female < 55 years) with acute MI (3 to 8 weeks prior), signed informed consent to participate, absence of generally accepted contraindications to performing exercise training
Exclusion criteria: left ventricular aneurysm with thrombosis, stroke, serious disturbances in the rhythm and conduction of the heart, uncontrolled arterial hypertension with blood pressure ≥ 180/100 mmHg, NYHA class III‐IV heart failure, thromboemboli, aortic aneurysm, history of syncope, thrombophlebitis, phlebothrombosis, musculoskeletal disorders, moderate to severe diabetes, severe concomitant diseases, chronic respiratory, hepatic or renal failure
N randomised: total: 300; intervention: 155; comparator: 145. Groups then split into 3 subgroups according to rehabilitation potential (intervention: low n = 32, average n = 55, high n = 68; control: low n = 22, average n = 64, high n = 59)
Diagnosis (% of participants): 100% acute MI (68% STEMI)
Age (mean ±SD): intervention: 49.9 ± 7.2; comparator 50.9 ± 6.1
Percentage male: intervention: 93.5%, comparator: 92.4%
Ethnicity: NR
Interventions Intervention: physical rehabilitation classes consisting of gymnastics exercises carried out for 60 minutes in groups under supervision of a cardiologist 3 times per week for 1 year.
Components: exercise only
Setting: centre‐based
Exercise programme modality: gymnastic exercises
Length of session: 1 hour
Frequency: three sessions per week
Intensity: not reported
Resistance training included? No
Total duration: 1 year
Co‐interventions: none described
Comparator: no exercise training
Co‐interventions: none described
Outcomes HRQoL, mortality, MI
Source of funding Not reported
Conflicts of interest None declared
Notes Paper translated from Russian
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomized using the envelope method"; no further detail reported
Allocation concealment (selection bias) Unclear risk "Patients were randomized using the envelope method"; no further detail reported
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No detail regarding outcome assessment blinding was reported
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No PRISMA flow diagram provided, no N in tables and text unclear about attrition, appears that there was no loss to follow‐up
Selective reporting (reporting bias) Unclear risk No published protocol, outcomes described in methods appear to be reported in the results. Cardiovascular complications unclear