Aronov 2010.
Methods |
Study design: Multicentre RCT (20 cities) Country: Russia Dates patients recruited: NR Maximum follow up: 1 year |
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Participants |
Inclusion criteria: Patients 3 to 8 weeks after MI, unstable angina or reconstructive coronary arteries intervention. In some cases (at discretion of the researchers) patients with stable angina after hospital treatment with unconfirmed diagnosis of MI or unstable angina were included in the study. Exclusion criteria: none reported N Randomised: total: 392; intervention: 197; comparator: 195 Diagnosis (% of pts): Stable angina: intervention: 62.7; comparator: 77.7 Post MI: intervention: 78.4; comparator: 77.3 Unstable angina: intervention: 5.0; comparator: 10.9 (not mutually exclusive). Age (mean ± SD): intervention: 51.9 ± 7.2; comparator: 51.9 ± 7 Percentage male: intervention: 95.5; comparator: 91.7 Ethnicity: NR |
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Interventions |
Intervention: Patients of the main group received moderate‐intensity PT (50‐60% of the performed capacity by bicycle ergometry (BE) test) 3 times per week with duration of exercises from 45 minutes to 1 hour for 1 year. Components: exercise only. Setting: NR Aerobic exercise: Modality: cycling. Length of session: 45‐60 mins. Frequency: 3 times a week. Intensity: 50‐60% of the performed capacity by bicycle ergometry test. Resistance training included? No. Total duration: 1 year. Co‐interventions: patients received standard medical therapy described below. Comparator: Patients received standard medical therapy which included beta‐blocker, acetylsalicylic acid or other antithrombotic drug, as well as nitrate, and ACE inhibitor. Some patients took lipid‐lowering drugs. Co‐interventions: none described |
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Outcomes | Mortality and 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 | Method of randomisation not described….“patients were randomised into 2 groups….”. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of assessments not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were similar for both groups. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported at all time points. |
Groups balanced at baseline | Low risk | “the groups did not differ in major clinical, anamnesis and functional indicators.” |
Intention‐to‐treat analysis conducted | Unclear risk | Intention‐to‐treat analysis is not reported, no details of how missing data is handled, and no Ns are given in the results tables. |
Groups received same treatment (apart from the intervention) | Low risk | Both groups received standard medical therapy. |