Methods | Parallel group RCT | |
Participants |
N Randomised: 200 (exercise 100; control 100) Diagnosis (% of participants): Aetiology: ischaemic 77%; hypertension 15.5%; DCM 5.5%; other 2% NYHA: Class II 51.5%; Class III 48.5% LVEF: 40‐35%: 16.5%; < 35‐30%: 45%; < 30%: 38.5% Case mix: 100% as above Age (yr): exercise 71.9 (SD 6.3); control 71.8 (SD 6.8) Male: 43% White: not reported Inclusion/exclusion criteria Inclusion: age > 60 yr, NYHA Class II or III, and LVSD < 40%, confirmed by echocardiography Exclusion: diastolic dysfunction, significant co‐morbidity preventing entry into study because of terminal disease or an inability to exercise (e.g. severe musculoskeletal disorder, unstable IHD, advanced valvular disease), resident outside the catchment area or in a long‐term care establishment |
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Interventions |
Exercise:Total duration: 24 wk Aerobic/resistance/mix: aerobic endurance training and low resistance training/high repetitive muscular strength work Frequency: 2 sessions/wk (for 8 wk), 1 session/wk (16 wk) plus 3 sessions/wk at home Duration: 2.5 hr class (8 wk) and 1 hr class (next 16 wk) Intensity: not reported Modality: not reported Setting: hospital and home Other: none |
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Outcomes | HRQoL (MLWHFQ and EuroQol/EQ‐5D); healthcare utilisation (length of stay of hospital, admissions arising from heart disease, prescribed HF medication); mortality | |
Comparison | Standard care group (including monitoring of clinical status, explanation of HF and its treatment self monitoring; dietary advice and contact details of clinical nurse specialist) | |
Country and setting | UK Single centre |
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Follow‐up | 6 months and 5 yr (after randomisation) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A computer was used to generate a list of random numbers" |
Allocation concealment (selection bias) | Low risk | "The numbers, placed in plain sealed envelopes by a university colleague prior to patient recruitment, were allocated to the participants by a hospital colleague unconnected with the study. The allocation schedule was not broken until the trial was completed" |
Blinding (performance bias and detection bias) All outcomes | High risk | No, for HRQoL. Data on deaths, admissions from the hospital records department |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods are reported |
Intention‐to‐treat analysis? | Low risk | Although term ITT not stated it appears from CONSORT diagram that ITT analysis undertaken |
Incomplete outcome data? | Low risk | CONSORT diagram presented showing participant flow. No imputation or sensitivity analysis to assess impact of loss or follow‐up |
Groups balanced at baseline? | Low risk | "There are no significant differences in the baseline parameters of the standard care and experimental groups" |
Groups received same intervention? | Low risk | Yes, both groups received usual medical care and the only difference between groups was the exercise intervention |