Witham 2005.
| Methods | Parallel‐group RCT | |
| Participants |
N randomised: 82 (exercise 41, control 41) Diagnosis (% of participants): Aetiology: IHD 66% NYHA: Class II 56%, Class III 44% LVEF: not reported Case mix: as above Age, years: exercise 80 (SD 6), control 81 (SD 4) Male: 55% White: not reported Inclusion/exclusion criteria: Inclusion: age ≥ 70 years with clinical diagnosis of CHF according to European Society of Cardiology guidelines; NYHA Class II or III symptoms and evidence of LVSD on echocardiography, contrast ventriculography, or radionuclide ventriculography; evidence of LVSD Exclusion: uncontrolled AF, significant aortic stenosis, sustained ventricular tachycardia, recent MI, inability to walk without human assistance, abbreviated mental score < 6 of 10, currently undergoing physiotherapy or rehabilitation |
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| Interventions |
Exercise: Total duration: 6 months Aerobic/resistance/mix: mix Frequency: 2 to 3 sessions/week Duration: 20 minutes Intensity: Borg 11 to 13 Modality: walking and wrist/ankle weights Setting: 3 months: hospital‐based by senior physiotherapist; 3 months: home‐based After 3 months of supervised training, participants in the exercise group were asked to continue to perform exercises at home 2 or 3 times/week with the aid of video or audio cassette with demonstrations, instructions, and music. No face‐to‐face contact was had with the physiotherapist during this period Other: not reported Control group / Comparison: Usual medical care |
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| Outcomes | Disease‐specific health‐related quality‐of‐life (Guyatt Chronic Heart Failure Questionnaire); mortality; hospitalisation | |
| Country and setting | UK Single centre |
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| Follow‐up | 6 months (after randomisation) | |
| Notes | Source of funding: Grant 2006/918 from The Health Foundation (formerly PPP Health Foundation), London, United Kingdom | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A researcher not otherwise connected with the operation of the study prepared cards contained in numbered, sealed envelopes from computer‐generated random number tables" |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) All outcomes | Low risk | "An experienced research nurse who was blinded to treatment allocation performed all assessments" |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results |
| Intention‐to‐treat analysis? | Low risk | It appears from the QUORUM diagram that groups were analysed according to the initial random allocation |
| Incomplete outcome data? | Low risk | 75/82 (91%) and 68/82 (83%) were available at 3 months' and 6 months' follow‐up, respectively |
| Groups balanced at baseline? | Low risk | Table 1 of the publication shows that groups were well balanced |
| Groups received same intervention? | Low risk | Yes, both groups appear to have received usual medical care; the only difference between groups was the exercise intervention |