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 (yr): exercise 80 (SD 6); control 81 (SD 4) Male: 55% White: not reported Inclusion/exclusion criteria Inclusion: age ≥ 70 yr 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, or people currently undergoing physiotherapy or rehabilitation |
|
Interventions |
Exercise:Total duration: 6 months Aerobic/resistance/mix: mix Frequency: 2‐3 sessions/wk Duration: 20 min Intensity: Borg 11‐13 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 performing exercises at home 2 or 3 times/wk with the aid of video or audio cassette with demonstrations, instructions and music. No face‐to‐face contact with the physiotherapist during this period Other: not reported |
|
Outcomes | A disease specific health‐related quality‐of‐life (Guyatt chronic heart failure questionnaire), mortality, hospitalisation | |
Comparison | Usual medical care | |
Country and setting | UK Single centre |
|
Follow‐up | 6 months (after randomisation) | |
Notes | ||
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 methods are reported in results |
Intention‐to‐treat analysis? | Low risk | It appeared that groups were analysed according to initial random allocation from QUORUM diagram |
Incomplete outcome data? | Low risk | 75/82 (91%) and 68/82 (83%) available at 3 and 6 months' follow‐up, respectively |
Groups balanced at baseline? | Low risk | Table 1 of the publication shows groups are well balanced |
Groups received same intervention? | Low risk | Yes, both group appeared to receive usual medical care and the only difference between groups was the exercise intervention |