Methods | Parallel group RCT | |
Participants |
N Randomised: 33 Diagnosis (% of participants): Aetiology: ischaemic or primary NYHA: Class II or III LVEF: exercise 22% (SD 8); control 25% (SD 10) Case mix: 100% as above Age (yr): exercise 67 (SD 7); control 64 (SD 10) Male: exercise 15/16 (94%); control 11/14 (79%); total 87% White: not reported Inclusion/exclusion criteria Inclusion: NYHA Class II‐III for at least 3 months and were on stable medications for the past 1 month. All participants were on maximal medical therapy with angiotensin‐converting enzyme inhibitors, diuretic and digoxin. All participants had EF < 40% by nuclear ventriculography. No participants had obstructive valvular disease, MI within 3 months, or limitation of exercise secondary to angina or new arrhythmias Exclusion: not reported |
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Interventions |
Exercise:Total duration: 3 months Aerobic/resistance/mix: aerobic Frequency: 3 session/wk Duration: 30 min Intensity: Borg 12‐13 Modality: bike and treadmill Setting: supervised sessions at medical centre by a nurse or exercise physiologist Other: Care provided by specialist HF physician |
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Outcomes | HRQoL (MLWHFQ and MOS SF‐36 questionnaire), mortality, morbidity | |
Comparison | Usual medical care Other: care provided by specialist HF physicians |
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Country and setting | USA Single centre |
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Follow‐up | 6 months (after randomisation) | |
Notes | MLWHF, MOS SF‐36 results not reported for the control group | |
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 (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods are reported |
Intention‐to‐treat analysis? | Unclear risk | Not reported |
Incomplete outcome data? | Low risk | Yes, QUORUM flow diagram reported Unclear how loss to follow‐up, drop‐out and cross‐over dealt with |
Groups balanced at baseline? | Low risk | "There were no differences at baseline between patients randomised to the control group and those randomised to the exercise program" |
Groups received same intervention? | Low risk | "Medical follow‐up of both the control and intervention patients groups was provided by specialized heart failure physicians" |