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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4
Methods Parallel group RCT
Participants N Randomised: 80 (exercise 40; control 40)
Diagnosis (% of participants):
Aetiology: ischaemic cardiomyopathy 69%; idiopathic DCM 18%; hypertensive HF 13%
NYHA: Class II 47%; Class III 35%
LVEF: exercise 31% (SD 8); control 31% (SD 9)
Case mix: 100% as above
Age (yr): 70.1 (SD 7.9)
Male: 79%
White: not reported
Inclusion/exclusion criteria
Inclusion: stable CHF and a LVEF < 40% or ≥ 40% with clinical symptoms of diastolic HF
Exclusion: acute MI within 4 wk; unstable angina pectoris; serious rhythm disturbance; symptomatic PVD; severe CPOD, with a forced expiratory vital capacity < 50% of expected measured by spirometry; 6‐min walking distance > 550 m; and work load on the cycle ergometer test > 110 watts, significant co‐morbidities that would prevent entry into the study due to terminal disease or an inability to exercise (e.g. severe musculoskeletal disorder, advanced valvular disease) or were in long‐term care establishments
Interventions Exercise:Total duration: 4 months
Aerobic/resistance/mix: aerobic
Frequency: 2 sessions/wk
Duration: 50 min
Intensity: 15‐18 on Borg scale
Modality: fast walking, side stepping and leg lifts in combination with overhead arm reaches
Setting: hospital outpatient department
Other: 15‐30 min counselling for participants in exercise group with CHF nurse (4 hr in total)
Outcomes HRQoL (MLWHFQ) and mortality
Comparison The control group was not provided with exercise prescriptions and encouraged to continue their usual levels of physical activity
Country and setting Norway
Single centre
Follow‐up 12 months (after randomisation)
Notes All training sessions were supervised by physiotherapist, a specialist in heart rehabilitation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "computer‐generated table of random numbers"
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) All outcomes Low risk "Three physicians and 3 nurses who were blinded to the clinical data and group assignments of the patients carried out all the follow‐up tests. Patients were told not to reveal to which groups they belonged"
Selective reporting (reporting bias) Low risk All outcomes described in methods reported in results
Intention‐to‐treat analysis? Low risk "Intention‐to‐treat analyses were performed"
Incomplete outcome data? Low risk 35/40 (88%) exercise training group and 37/40 (93%) control group available at 12 months
Groups balanced at baseline? Low risk Table 1 of the publication suggests no difference between the 2 groups
Groups received same intervention? Low risk Yes