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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
Methods Parallel group RCT
Participants N Randomised: 26 (exercise 16; control 10)
Diagnosis (% of participants):
Aetiology: DCM 7%; ischaemic 100%
NYHA: Class II 58%; Class III 42%
LVEF: < 40%
Case mix: 100% as above
Age (yr): exercise 52 (SD 9); control 53 (SD 11)
Male: 100% White: not reported
Inclusion/exclusion criteria
Inclusion:aetiology of CHF was either ischaemic heart disease or DCM. Diagnosis of CHF was mainly based on clinical signs (NYHA Class II and III), radiological findings, and echocardiographically determined EF < 40% and shortening fraction < 30%
Exclusion: recent MI or unstable angina; aortic stenosis; DM; uncontrolled hypertension; musculoskeletal limitations or other contraindications for participating in an exercise training programme; documented exercise‐induced severe ischaemia or serious arrhythmias or both
Interventions Exercise:Total duration: 6 months
Aerobic/resistance/mix: mix
Frequency: 3 or 4 sessions/wk
Duration: 60 min/session
Intensity: 50‐75% peak VO2
Modality: cycle ergometer, walking or jogging, stair climber and step‐aerobics
Plus 'light' resistance exercise (not defined)
Setting: supervised exercise training programme at institution
Other: none reported
Outcomes HRQoL (MLWHFQ and Spritzer Quality of Life Index)
Comparison Not reported
Country and setting Greece
Single centre
Follow‐up 6 months (after randomisation)
Notes
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 Low risk "The psychological tests were assessed from all patients in the first week of admission, before randomization to study groups and the end of the study by the same physician, who was not familiar with the patients"
Selective reporting (reporting bias) Low risk All outcomes outlined in methods are reported
Intention‐to‐treat analysis? Low risk Not stated explicitly but appear to analysed according to initial group allocation
Incomplete outcome data? Unclear risk Losses to follow‐up, drop‐outs not reported
Groups balanced at baseline? Low risk "The two groups of patients participating in the study were similar as regards their clinical data"
Groups received same intervention? Unclear risk Not reported