Bocalini 2008

Methods	Parallel group RCT
Participants	N Randomised: 42 (exercise 22; control 20) Diagnosis (% of participants): Aetiology: MI 45.2%; systemic hypertension 19%; dilated Chagas' cardiomyopathy 11.9%; DM 4.8%; other 19.1% NYHA: Class II or III LVEF: ≤ 45% Case mix: 100% as above Age (yr): exercise 61 (SD 12); control 60 (SD 11) Male: 88% White: not reported Inclusion/exclusion criteria Inclusion: EF < 45%, symptoms of NYHA functional Class II or III, optimised pharmacological therapy established at least 4 wk before inclusion in the study, and compensated HF state at least 2 months prior Exclusion: age < 50 yr, NYHA functional Class IV, clinical instability in the preceding 2 months, non‐optimised therapy, uncontrolled arrhythmias, MI within the last 2 months, surgery‐associated cardiomyopathy, pulmonary disease or other co‐morbid conditions that limit physical exercise, accentuated severe cardiac symptoms (hypotension, complex ventricular arrhythmia, progressive worsening of dyspnoea and significant ischaemia at low rates) during ergometric tests, regular participation in some exercise programme within the last 6 months and a frequency in training protocol of < 80%
Interventions	Exercise:Total duration: 6 months Aerobic/resistance/mix: aerobic Frequency: 3 sessions/wk Duration: 90 min Intensity: target HR (50% of work in the max HR) Modality: walking on a treadmill Setting: not reported Other: relaxation and stretching exercises before and after every session
Outcomes	HRQoL (shortened version of World Health Organization Quality of Life questionnaire), hospitalisation
Comparison	Usual medical therapy ‐ individual dietary guidance and pharmacological therapy
Country and setting	Brazil Single‐centre
Follow‐up	6 months (after randomisation)
Notes	Initially randomised 53 participants, excluded data from participants who withdrew, lost to follow‐up, etc. and hence 42 participants were analysed Although setting not reported, the exercise programme was described as "supervised"
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?	High risk	"During the follow‐up, medicine doses were not modified except for those that presented impairment of symptoms and, consequently, these patients were excluded from the analysis"
Incomplete outcome data?	High risk	"…3 patients from the untrained group experienced an impairment of symptoms and were hospitalized"
Groups balanced at baseline?	Low risk	Table 1 of the publication shows groups are well balanced
Groups received same intervention?	Low risk	"All patients continued with pharmacological therapy and individual dietary guidance"