Nilsson 2008.
| 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, years: 70.1 (SD 7.9) Male: 79% White: not reported Inclusion/exclusion criteria: Inclusion: stable CHF and LVEF < 40% or ≥ 40% with clinical symptoms of diastolic HF Exclusion: acute MI within 4 weeks; unstable angina pectoris; serious rhythm disturbance; symptomatic PVD; severe COPD, with forced expiratory vital capacity < 50% of expected measured by spirometry; 6‐minute walking distance > 550 m; workload on the cycle ergometer test > 110 watts; significant co‐morbidities that would prevent entry into the study due to terminal disease or inability to exercise (e.g. severe musculoskeletal disorder, advanced valvular disease); in long‐term care establishment |
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| Interventions |
Exercise: Total duration: 4 months Aerobic/resistance/mix: aerobic Frequency: 2 sessions/week Duration: 50 minutes Intensity: 15 to 18 on Borg scale Modality: fast walking, side‐stepping, and leg lifts in combination with overhead arm reaches Setting: hospital outpatient department Other: 15 to 30 minutes of counselling with CHF nurse for participants in the exercise group (4 hours in total) Control group / Comparison: Control group was not provided with exercise prescriptions and was encouraged to continue usual levels of physical activity |
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| Outcomes | HRQoL (MLWHF questionnaire); mortality | |
| Country and setting | Norway Single centre |
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| Follow‐up | 12 months (after randomisation) | |
| Notes | All training sessions were supervised by a physiotherapist ‐ a specialist in heart rehabilitation Source of funding: not reported |
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| 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 the methods were reported in the results |
| Intention‐to‐treat analysis? | Low risk | "Intention‐to‐treat analyses were performed" |
| Incomplete outcome data? | Low risk | 35/40 (88%) in the exercise training group and 37/40 (93%) in the control group were available at 12 months |
| Groups balanced at baseline? | Low risk | Table 1 of the publication suggests no differences between the 2 groups |
| Groups received same intervention? | Low risk | Yes |