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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
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