Munk 2009.
Methods |
Study design: Single centre RCT Country: Norway Dates patients recruited: NR Maximum follow up: 6 months |
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Participants |
Inclusion criteria: Successful PCI, defined as a residual diameter stenosis after stent implantation of < 20% of the reference diameter. Exclusion criteria: History of myocardial infarction (MI) or CABG; significant valvular heart disease; > 80 years; inability to give informed consent; inability to participate in regular training due to residency, work situation or comorbidity; any known chronic inflammatory disease other than atherosclerosis, or planned surgery within the next 6 months. N Randomised: total: 40; intervention: 20; comparator: 20 Diagnosis (% of pts): Stable angina, post PCI: intervention: 85%; comparator: 95% Unstable angina, post PCI: intervention: 15%; comparator: 5% Age (mean ± SD): intervention: 57 ±14; comparator: 61 ± 10 Percentage male: Total: 21%; intervention: 18%; comparator: 25% Ethnicity: NR |
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Interventions |
Intervention: Starting 11 ± 4 days after PCI,the training model included 10 min warm‐up at 60% to 70% of max HR, followed by 4 min intervals at 80% to 90% of max HR, when patients were riding an ergometric bicycle or were running. Intervals were interrupted by 3 minutes of active recovery at 60% to 70% of maximal heart rate. Afterwards, there was 5 min cool‐down, 10 min of abdominal and spine resistance exercises, and 5 min of stretching and relaxing. The training sessions were monitored with individual pulse watches allowing the patient to achieve the target heart rate. Components: exercise only. Setting: centre‐based supervised training in groups of 10. Aerobic exercise: Modality: ergometric bicycle or running. Length of session: 1 hour. Frequency: 3 times a week. Intensity: 60‐70% max HR. Resistance training included? Spine & abdominal resistance exercises. Total duration: 6 months. Co‐interventions: None described. Comparator: Participants received usual care (not described), including drug therapy of clopidogrel, aspirin and statins. Co‐interventions: None described. |
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Outcomes | Mortality, MI, and revascularisations. | |
Source of funding | Norwegian Health Association, Oslo, Norway, and Stavanger University Hospital. | |
Conflicts of interest | NR in this paper, but none declared in Munk 2011. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “The order of treatments within the block was randomly permuted by a computer‐generated sequence.” |
Allocation concealment (selection bias) | Low risk | “The investigator, who recruited patients into the trial, was unaware of the group to which a participant was allocated.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “All scans were analysed twice with EchoPACtm (GE Vingmed Ultrasound) by two blinded investigators. Two experienced cardiologists independently interpreted the images in a blinded manner.” However, not clear if blinded for clinical events and exercise capacity. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | “No patient was lost to follow up.” |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods were reported at all time points. |
Groups balanced at baseline | Low risk | “There were no significant differences in risk profile, clinical presentation, medical treatment, or angiographic or procedural characteristics between the 2 groups.” |
Intention‐to‐treat analysis conducted | Unclear risk | Not stated but no loss to follow up and groups appear to be analysed according to original random allocation. |
Groups received same treatment (apart from the intervention) | Low risk | “All patients received Aspirin, Clopidogrel and a statin during the study period.” |