Miller 1984.
Methods |
Study design: RCT; patients randomised 3 weeks post‐MI Country: USA Dates patients recruited: NR Maximum follow up: 6 months |
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Participants |
Inclusion criteria: Men < 70 yrs with MI documented by the combination of characteristic elevation of serum creatine kinase or oxaloacetic transaminase, a history of prolonged chest pain consistent with myocardial infarction, and the appearance of new Q waves or evolutionary ST segment changes. Exclusion criteria: Conditions that precluded symptom‐limited treadmill testing 3 weeks after infarction. e.g. congestive heart failure, unstable angina pectoris, valvular heart disease, atrial fibrillation, bundle branch block, stroke, limiting orthopedic abnormalities, peripheral vascular disease, chronic obstructive pulmonary disease and obesity, a history of coronary artery bypass graft (CABG) surgery, reinfarction before testing, and intercurrent noncardiac illness. N Randomised: total: 198; group 1: 66; group 2: 61; group 3: 34; comparator: 37 Diagnosis (% of pts): MI: 100% Age (mean ± SD): 52 ± 9 Percentage male: intervention: 100%; comparator: 100% Ethnicity: NR |
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Interventions | Patients were randomly assigned to one of four exercise protocols:
Regimens of home and group exercise training were designed to provide a similar intensity and duration of exercise training. Intervention: home training. Components: exercise. Setting: home. Aerobic exercise: Modality: stationary cycling or walking. Length of session: 30 min. Frequency: 5 days a week. Intensity: week 3‐11: 70% to 85% of the peak heart rate at week 3; Week 11‐ 26: 70% to 85% of the peak heart rate at week 11. Resistance training included? No. Total duration: 8 weeks or 26 weeks. Co‐interventions: none described. Intervention: group training. Components: exercise. Setting: supervised in centre. Aerobic exercise: Modality: walking or jogging. Length of session: 1 hour. Frequency: 3 times a week. Intensity: Patients regulated their training intensity by palpation of the radial or carotid pulse during the first 10 sec after brief cessation of walking or jogging. Resistance training included? No. Total duration: 8 weeks or 26 weeks. Co‐interventions: none described. Comparator: usual care (treadmill testing for the first time at 26 weeks). Co‐interventions: none described. |
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Outcomes | CHD mortality, non fatal MI and revascularisation. | |
Source of funding | Supported by grant from the NHLBI, Bethesda, and by a grant from the PepsiCo Foundation, Purchase, NY. | |
Conflicts of interest | NR | |
Notes | Low rate of cardiac events reflects identification of low risk population. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
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 | 5% lost to follow up, no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | Low risk | All outcomes reported for all time points. |
Groups balanced at baseline | Low risk | “Demographic and medical characteristics were not significantly different between groups.” No data given. |
Intention‐to‐treat analysis conducted | High risk | No. |
Groups received same treatment (apart from the intervention) | Low risk | Intervention included exercise only. |