Fletcher 1994.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: USA Dates participants recruited: NR Maximum follow‐up: 6 months |
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Participants |
Inclusion criteria: ≤ 73 years; CAD and physical disability. CAD documented by history of MI, coronary artery bypass surgery, PCI or angiographically demonstrated CAD; have the functional use of more than 2 extremities, 1 being an arm, in order to perform the exercise test and training protocols. Exclusion criteria: uncontrolled hypertension or diabetes mellitus, clinically significant cardiac dysrhythmias, unstable angina pectoris, cognitive deficits, or other problems that would interfere with compliance to the prescribed exercise and diet protocol. N randomised: total: 88; intervention: 41; comparator: 47 Diagnosis (% of participants): CAD and a physical disability Age (mean ±SD): intervention: 62 ± 8; comparator: 63 ± 7 Percentage male: intervention: 100%; comparator: 100% Ethnicity: NR |
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Interventions |
Intervention: participants were provided with a wheelchair ramp with rollers and a telephone electrocardiographic recording device. They were instructed to exercise using the ramp which essentially transformed their wheelchair into a stationary wheelchair ergometer. Specific instructions were to exercise 5 days/week for 20 minutes a day for a total of 100 minutes each week. Components: exercise plus education Setting: home Exercise programme modality: stationary wheelchair ergometer Length of session: 20 min Frequency: 5 days/week Intensity: 85% of predicted maximal heart rate Resistance training included? No Total duration: 6 months Co‐interventions: both groups received didactic and written dietary instruction from a registered dietitian on the American Heart Association Step I low‐cholesterol, low‐saturated fat diet. Comparator: usual care Co‐interventions: participants in the control group received dietary instruction and were instructed to follow activity guidelines provided by their primary physician and health care team. |
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Outcomes | Total mortality, non‐fatal MI at 6 months | |
Source of funding | United States Department of Education | |
Conflicts of interest | NR | |
Notes | The treatment programme decreased myocardial oxygen demand. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The same experienced cardiologist interpreted all echocardiograms and was unaware of randomization procedures" |
Incomplete outcome data (attrition bias) All outcomes | High risk | 32% lost to follow‐up; no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Low risk | All outcomes reported for all time points. |