Bäck 2008.
Methods |
Study design: Single centre RCT Country: Sweden Dates patients recruited: 2004 to 2006 Maximum follow up: 8 months (6 months following PCI) |
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Participants |
Inclusion criteria: Coronary artery stenosis documented by angiography or previous coronary artery bypass grafting, classes I‐III angina pectoris, classified according to Canadian Cardiovascular Society. Exclusion criteria: disabling disease that hindered regular exercise, or if the patient has already engaged in exercise more than 3 days/week. N Randomised: total: 37; intervention: 21; comparator: 16 Diagnosis (% of pts): stable CAD: 100 % Age (years): 63.6 years; intervention: 61.5 (59.8 ‐ 65.5) ; comparator: 64 (58.5 ‐ 71.0) Percentage male: 86.5%. intervention: 81.0%; comparator: 93.8% Ethnicity: NR |
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Interventions |
Intervention: Patients were asked to exercise at home on a bicycle ergometer for 30 min (including a 10 min warm up and a 5 min cool down), 5 days a week for 8 months. The training programme was initiated 2 months before the PCI. Twice a week the training patients were allowed to exchange cycling for an equivalent exercise such as jogging or swimming. Components: exercise and education. Setting: home. Aerobic exercise: Modality: bicycle ergometer. Length of session: 30 min. Frequency: 5 times a week. Intensity: 70% of V02max. Resistance training included? Resistance exercise with elastic bands, 3 times a week. Total duration: 8 months. Co‐interventions: Patients in both groups were invited to participate in the CR care consisting of group‐based lifestyle education and aerobic as well as resistance exercise twice a week during months 4 to 6. Comparator: usual care. Co‐interventions: as above. |
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Outcomes | PCI at 2 months before PCI and 6 months after PCI. | |
Source of funding | The Swedish Heart Association, The Research and Development Council for Southern Gothenberg and Bohuslan, and Rene Eanders Foundation. | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised". |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 8.1% lost to follow‐up, no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | Low risk | All outcomes reported at all time points (although absolute values not always given). |
Groups balanced at baseline | High risk | “There were no significant differences in baseline characteristics between the training and control group, except for physical activity with the control group being more physically active”. |
Intention‐to‐treat analysis conducted | Low risk | Yes. |
Groups received same treatment (apart from the intervention) | Low risk | “patients were randomised,….to either training group or control group. All patients in the training group were asked to exercise……”. |