Stern 1983.
Methods |
Study design: Single centre RCT Country: USA Dates patients recruited: NR Maximum follow up: 1 year. Randomised by blocks of 6 into one of three groups: exercise, group counselling & control. |
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Participants |
Inclusion criteria: Aged 30 to 69 years with documented MI not less than six weeks nor more than one year prior to admission to the study. Work capacity level < 7 MET (men) or < 6 MET (women) or a Taylor Manifest Anxiety Scale raw score of 19 + or Zung Self‐rating Depression Scale raw score of 40 +, or any or all of these. Exclusion criteria: Presence of unstable cardiovascular condition i.e. congestive heart failure, or requirement of treatment for any physical/psychological reason. N Randomised: total: 106; intervention: 42; comparator (usual care): 29; group counselling: 35 (no data analysed in this review) Diagnosis (% of pts): MI: 100% Age (mean): 54 Percentage male: intervention: 90%; comparator: 76% Ethnicity: 85% white |
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Interventions |
Intervention: Three one‐hour sessions per week over a 12‐week period. All exercises were dynamic, involving rhythmic movements against resistance. Half were upper limb (rowing machine, arm wheel, and arm ergometer) and half were lower limb (treadmill, cycle, and step ergometer). Patients exercised upper and lower limbs alternately for four minutes with two minutes of rest in between. The intensity of exercise was determined by heart‐rate response, the target level being 85% of the peak exercise heart rate achieved in the first evaluation. If the heart rate was consistently above or below target, the work load was increased or decreased. Components: exercise. Setting: supervised in a centre. Aerobic exercise: Modality: e.g. rowing, treadmill, cycle or step ergometer. Length of session: 1 hour. Frequency: 3 times a week. Intensity: Target HR 85% of HR max during exercise treadmill test. Resistance training included? No. Total duration: 12 weeks. Co‐interventions: none described. Comparator: followed up by their physicians and given routine post‐MI medical care. Patients were requested to not join a supervised exercise or a formal counselling programme. Co‐interventions: none described. |
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Outcomes | Mortality, non fatal MI. | |
Source of funding | National Institute of Handicapped Research, Department of Education, Washington, DC. | |
Conflicts of interest | NR | |
Notes | Minimal differences between groups at one year. | |
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 | 7.7% 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 | High risk | "More controls were in the unmarried category (P < 0.003), more exercise patients were in the 49‐ to 58‐year‐old age range (P <.02), and more group patients were admitted less than four months following myocardial infarction (P < 0.05)". |
Intention‐to‐treat analysis conducted | High risk | No. |
Groups received same treatment (apart from the intervention) | Low risk | “Randomization to one of three groups, exercise, group counseling, or control.” “Patients in the control group received no specific assignment. Instead, they were followed up by their physicians and given routine postmyocardial infarction medical care. They were requested to not join a supervised exercise or a formal counselling program." |