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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
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
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
Outcomes HRQoL (MLWHFQ and MOS SF‐36 questionnaire), mortality, morbidity
Comparison Usual medical care
Other: care provided by specialist HF physicians
Country and setting USA
Single centre
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"