Methods | Parallel group RCT | |
Participants |
N Randomised: 40 (exercise 21; control 19) Diagnosis (% of participants): Aetiology: DCM 40%; IHD 60% NYHA: Class II 67.5%; Class III 32.5% LVEF: 21% (SD 7) Case mix: 100% as above Age (yr): 56 (SD 11) Male: 100% White: 62.5% (remainder black) Inclusion/exclusion criteria Inclusion: NYHA Class II or III, resting EF < 35% measured by echocardiography or gated equilibrium radionuclide angiography and no change in medical therapy >=30 days before randomisation. Exclusion: AF, acute MI ?3 months, angina pectoris at rest or induced by exercise, current enrolment in another clinical trial, and current participation in a regular exercise programme (at least twice weekly) |
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Interventions |
Exercise:Total duration: 24 wk Aerobic/resistance/mix: aerobic Frequency: 3 sessions/wk (rate of perceived exertion 12‐14) Duration: 33 min Intensity: 60‐80% peak HR Modality: treadmills, stationary cycles, rowing machines and arm ergometers Setting:outpatient clinic Other: none reported |
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Outcomes | Morality and hospital admissions | |
Comparison | Usual medical care Participants were instructed to maintain their normal daily activity habits and not to begin an exercise regimen |
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Country and setting | North America Single centre |
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Follow‐up | 6 months (after randomisation) | |
Notes | Authors contacted for further details of outcome findings but no information provided. Each participant's physician was asked not to change drug regimen during the study, if possible | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned to the exercise group or the control group" |
Allocation concealment (selection bias) | Unclear risk | "Each patient's assignment was sealed in an envelope until completion of the second exercise test" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods reported in results |
Intention‐to‐treat analysis? | Low risk | "Of the 40 patients entered into the study, only those who also completed the exercise tests at weeks 12 and 24 were considered in the data analysis" |
Incomplete outcome data? | Low risk | "Fifteen patients in the exercise group completed the study. Two patients dropped out because of noncardiac medical conditions (progressive, limiting arthritis in one patient and newly diagnosed cancer in the other) that developed within 1 month of the start of the exercise program. One patient developed atrial fibrillation between week 12 and week 24; 3 other patients stopped exercising for personal reasons before week 12 and refused follow‐up testing. Fourteen of the 19 patients in the control group completed the study. Two dropped out for personal reasons and refused follow‐up testing, one developed atrial fibrillation between week 12 and week 24, one was hospitalized at week 22 for an acute myocardial infarction, and one died suddenly" |
Groups balanced at baseline? | Low risk | "Among patients who completed the study, no differences in demographic characteristics were seen between the two study groups after randomization" |
Groups received same intervention? | Unclear risk | The co‐interventions in the control group not reported |