Bubnova 2019.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: Russia Dates participants recruited: NR Maximum follow‐up: 12 months. |
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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 |
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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 |
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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 |