Klocek 2005 (Const)

Methods	Parallel group RCT
Participants	N Randomised: 42 (exercise group A 14; control 14) Diagnosis (% of participants):  Aetiology: ischaemic 100% NYHA: Class II/III exercise group A 55%; control 100% LVEF: exercise group A: mean 33.6% (SD 3.6); control 33.2% (SD 3.8) Case mix: 100% as above Age (yr): exercise group A 54 (SD 7); control 55 (SD 9) Male: 100% White: not reported Inclusion/exclusion criteria Inclusion: stable CHF, LVEF < 40% on echocardiography =<1 month before inclusion, age < 65 yr Exclusion: moderate or severe pulmonary disease, orthostatic blood pressure fall (> 20 mmHg), or with MI, unstable angina, heart surgery or coronary angioplasty within 3 months prior to inclusion as well as inability to perform bicycle training
Interventions	Exercise:Total duration: 6 months Aerobic/resistance/mix: aerobic Frequency: 3 sessions/wk Duration: group A ‐ 20 min/session (4‐min constant workload with 1 min rest repeated 5 times) Intensity: group A ‐ 60% max HR Modality: cycle ergometer Setting: CR, outpatient unit under supervision of the physician and rehabilitation specialist Other: none reported
Outcomes	HRQoL (Psychological General Wellbeing Index)
Comparison	Description: controls were asked not to change their degree of physical activity during the study
Country and setting	Poland Single centre
Follow‐up	26 wk (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	"Results of baseline QoL examinations were not known to the patients and their physicians or to the persons performing the randomisation"
Selective reporting (reporting bias)	Low risk	All outcomes described in methods are reported in results
Intention‐to‐treat analysis?	Low risk	It appears that groups were analysed according to initial random allocation
Incomplete outcome data?	Unclear risk	No information presented on loss on loss to follow‐up or drop‐outs
Groups balanced at baseline?	Low risk	"At baseline there were no significant differences in between groups in left ventricular ejection fraction and other basic parameters of left ventricular function." "At the start of the study, mean PGWB [Psychological General Wellbeing Index] total index was similar in groups A and B. Controls had lower total index than patients in group B"
Groups received same intervention?	Unclear risk	Details of co‐interventions not reported although degree of follow‐up was stated to be equivalent