Giannuzzi 2003

Methods	Parallel group RCT
Participants	N Randomised: 90, 45 each group Diagnosis (% of participants): Aetiology: HF secondary to idiopathic DCM; ischaemic heart disease; valvular disease NYHA: Class II‐III LVEF: exercise 25% (SD 4); control 25% (SD 4) Case mix: 100% Age (yr): exercise 60 (SD 7); control 61 (SD 7) Male: not reported White: not reported Inclusion/exclusion criteria Inclusion: 1. HF secondary to idiopathic DCM, ischaemic heart disease or valvular disease; 2. echocardiographic ejection fraction < 35%; 3. clinical stability for at least 3 months under optimised therapy; 4. NYHA functional Class II to III; 5. peak oxygen uptake (VO2) < 20 mL/kg/min; and 6. echocardiographic images of adequate quality for quantitative analysis Exclusion: any systemic disease limiting exercise, hypertrophic cardiomyopathy, valvular disease requiring surgery, angina pectoris, sustained ventricular arrhythmias, severe hypertension, excess variability (> 10%) at baseline cardiopulmonary exercise test and inability to participate in a prospective study for any logistic reason
Interventions	Exercise:Total duration: 24 wk Aerobic/resistance/mix: aerobic Frequency: 3‐5 sessions/wk Duration: 30 min Intensity: 60% peak VO2 Modality: exercise cycle, daily brisk walk, callisthenic. In addition, requested to take brisk daily walk of > 30 min Setting: supervised cycling sessions at rehabilitation centre and unsupervised at home Other: not reported
Outcomes	Mortality and morbidity
Comparison	Educational support but no formal exercise protocol
Country and setting	Italy Multicentre (15 CR units)
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	Unclear risk	Not reported
Selective reporting (reporting bias)	Low risk	All outcomes reported in methods are reported
Intention‐to‐treat analysis?	Low risk	Although not stated, it is clear from CONSORT diagram that 2 groups were analysed according to ITT
Incomplete outcome data?	Low risk	45/45 (100%) exercise training group and 44/45 (98%) available at 6 months' follow‐up
Groups balanced at baseline?	Low risk	"No significant differences were observed between the 2 groups with respect to demographic and clinical data, including age, weight, cause of heart failure, or New York Heart Association functional class. Furthermore, there was no difference between the 2 groups in the medications received during the 6‐month period of the study"
Groups received same intervention?	Unclear risk	Not clearly stated if co‐treatments (i.e. cardiovascular medication) in 2 groups were the same