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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
Methods Parallel group RCT
Participants N Randomised: 43 (exercise 21; control 22)
Diagnosis (% of participants):
Aetiology: ischaemic 79%; AF 12%; valvular 7%; hypertension 2%
NYHA: Class II and III
LVEF: exercise 41.5 (SD 13.6); control 40.6% (SD 13.7)
Case mix: as above
Age (yr): exercise 68 (SD 7); control 69 (SD 5)
Male: 79%
White: not reported
Inclusion/exclusion criteria
Inclusion: CHF diagnosis, on CHF medication, clinical symptoms of CHF, clinically stable > 3 months before study entrance, fulfil 1 of the following criteria: previous MI, hospitalised because of CHF, lung oedema and cardiac enlargement on X‐ray
Exclusion: chronic obstructive lung disease, orthopaedic disabilities, psychiatric disabilities, cancer, senility and age > 80 yr
Interventions Exercise:Total duration: 5 months
Aerobic/resistance/mix: mix
Frequency: 2 sessions/wk
Duration: 45 min
Intensity: not reported
Modality: cycling, free weights and elastic rubber‐bands (Thera‐bands)
Setting: hospital outpatients, supervised by physiotherapists
Other: training group had 3 educational lectures, about nutrition, physical activity and relaxation in addition to the exercise programme
Outcomes Rehospitalisation and mortality
Comparison Usual medical care (continued their previous level of physical activity, which varied from performing little physical activity up to taking a daily walk outdoors)
Country and setting Iceland
Single centre
Follow‐up 12 and 28 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 described in methods reported in results
Intention‐to‐treat analysis? Low risk Although not reported as ITT analysis, groups did appear to be analysed according to original randomised allocation
Incomplete outcome data? Low risk No losses to follow‐up
Groups balanced at baseline? Low risk Table 2 of the publication suggests 2 groups are well balanced
Groups received same intervention? Low risk Yes, both groups appeared to receive same interventions apart from CR intervention