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 |