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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
Methods Parallel group RCT
Participants N Randomised: 107 (exercise 53; control 54)
Diagnosis (% of participants):
Aetiology: ischaemic 62.6%
NYHA: Class II 79%; Class III 21%
LVEF: not reported
Case mix: as above
Age (yr): exercise 80.4 (SD 5.8); control 79.5 (SD 4.9)
Male: exercise 35%; control 37%
White: 100%
Inclusion/exclusion criteria
Inclusion: age ≥ 70 yr with a confirmed diagnosis of HF due to LVSD (NYHA Class II and III) and a history of symptoms and signs of congestive HF
Exclusion: wheelchair bound, unwilling or unable to give informed, had aortic stenosis with peak gradient > 30 mmHg, experienced sustained ventricular tachycardia or ventricular fibrillation outside the context of an acute MI, and currently (within the past month) had unstable angina or AF with a ventricular rate of > 100/min
Interventions Exercise:Total duration: 24 wk
Aerobic/resistance/mix: mix
Frequency: 2 sessions/wk
Duration: ≤ 60 min
Intensity: not reported
Modality: home; walking
Setting: hospital and home*
Other: cognitive and behavioural techniques were incorporated into first 8‐wk hospital‐based rehabilitation. Resistance training with elasticised bands
Outcomes Disease‐specific HRQoL (MLWHFQ), HRQoL (EuroQoL‐5D), mortality, hospital admission, cost
Comparison Usual medical care (given a booklet with general advice on diet, exercise and lifestyle). Not discouraged from exercising if they were already in the habit of doing so
Country and setting UK
Single‐centre
Follow‐up 24 wk (after randomisation)
Notes *8 wk in hospital delivered by experienced physiotherapist, 16‐wk home‐based (telephoned every 2 wk for 8 wk by the physiotherapists, then monthly for the final 8 wk)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Using off‐site telephone randomization service, randomization was performed without stratification and with block sizes between 8 and 16, depending on the size of each planned exercise class"
Allocation concealment (selection bias) Low risk "…the project coordinator passed the participants'details to the research physiotherapist who obtained group allocation, ensuring that the project coordinator remained blind to group assignments"
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 Analyses were by ITT
Incomplete outcome data? Low risk 89/104 (86%) and 87/104 (83%) available for follow‐up at 8 and 24 wk, respectively
Groups balanced at baseline? Low risk Table 1 of the publication suggests no difference between the 2 groups
Groups received same intervention? Low risk It appeared that both groups received same care expect exercise intervention