Belardinelli 2012

Methods	Parallel group RCT
Participants	N Randomised: 123 (exercise 63; control 60) Diagnosis (% of participants): Aetiology: ischaemic 80%; non‐ischaemic 20% NYHA: Class II 59%; Class III 41% LVEF: 37 (SD 8) Case mix: see above Age (yr): 59 (SD 14) Male: 78% White: not reported Inclusion/exclusion criteria Inclusion: clinical stability for 3 months before enrolment, LVEF < 40% and ability to exercise Exclusion: haemodynamically significant valvular heart disease, uncontrolled DM and hypertension, orthopaedic or neurological problems, and renal insufficiency (creatinine > 2.5 mg/dL)
Interventions	Exercise:Total duration: 10 yr; 8 wk supervised then 12 months maintenance Aerobic/resistance/mix: aerobic Frequency: 2‐3 sessions/wk Duration: 40 min/session Intensity: 60% max VO2 for first 2 months, and thereafter at 70% max VO2 Modality: cycling Setting: Hospital and home‐based Other: trained participants were encouraged to exercise without supervision at home at least a third time, performing aerobic activities at the same HR as the other 2 supervised sessions. Exercises sessions held at the hospital were supervised by cardiologists. Authors emphasise that the supervised element was maintained over the 10 yr of follow‐up.
Outcomes	HRQoL (MLWHQ), mortality, morbidity (including hospitalisation), cost‐effectiveness
Comparison	Standard medical care. Participants were instructed to continue with their usual home daily physical activities, avoiding exercise training in a supervised environment. They were free to perform aerobic activities such as walking, cycling (home or outside), and swimming, avoiding a duration of longer than 30 min. Authors advised control group participants to walk and perform usual physical activities.
Country and setting	Italy Single centre
Follow‐up	10 yr (every 12 months) (after randomisation)
Notes	Every 6 months, participants exercised at the hospital, and then they returned to a coronary club, where they exercised the rest of the year.
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, reported in results
Intention‐to‐treat analysis?	Low risk	"All analysis were performed with an intention‐to‐treat principle"
Incomplete outcome data?	Low risk	Losses to follow‐up reported. Drop‐out rate was 3% on average in the exercise group. 2/63 did not complete the protocol, 1 because of a car accident and the other for personal reasons. 3/60 in control group decided to withdraw from study for reasons unrelated to their clinical status.
Groups balanced at baseline?	Low risk	"The baseline characteristics of the study population are shown in Table 1. The 2 groups were well balanced with respect to most characteristics, including peak VO2, New York Heart Association functional class, left ventricular ejection fraction. There were no difference in type and doses of medication, blood chemistry, and previous cardiac events."
Groups received same intervention?	Low risk	Both groups appeared to receive same interventions apart from CR intervention.