Willenheimer 2001

Methods	Parallel group RCT
Participants	N Randomised: 54 (exercise 27; control 27) Diagnosis (% of participants): Aetiology: ischaemic 80%; non‐ischaemic 20% NYHA: exercise 2.1 (SD 0.7); control 2.4 (0.7) LVEF: exercise 35% (SD 12); control 38% (SD 10) Case mix: 100% as above Age (yr): exercise 64 (SD 5); control 64 (SD 9) Male: exercise 73%; control 70% White: not reported Inclusion/exclusion criteria Inclusion: 1. 8 points on Boston heart failure criteria; 2. LVEF 0.45 at the most recent radionuclide or echocardiographic examination (not older than 1 year at inclusion) and 3. age 75 yr Exclusion: 1. change of clinical status or medication (or both) within 4 wk prior to inclusion; 2. MI, heart surgery or coronary angioplasty within 3 months prior to inclusion; 3. inability to perform a bicycle test; 4. exercise‐terminating angina pectoris, ST‐depressions (> 2 mm in > 1 lead), blood pressure fall (>.10 mm Hg), or arrhythmia (e.g. ventricular tachycardia/fibrillation, ventricular extrasystoles, supraventricular tachycardia > 170 bpm) at the most recent maximal exercise test (including the baseline test); 5. pulmonary disease judged to be the main exercise‐limiting factor or peak expiratory flow rate < 50% of the age‐ and sex‐adjusted reference value, or both; 6. NYHA Class IV and 7. clinically significant aortic stenosis
Interventions	Exercise:Total duration: 4 months Aerobic/resistance/mix: aerobic/interval Frequency: 2‐3 sessions/wk Duration: 15 min/session increasing to 45 min/session Intensity: 80% peak VO2, or 15 on Borg score Modality: cycle ergometry Setting: group sessions supervised by physiotherapist Other: none
Outcomes	HRQoL (Patient's Global Assessment of Quality of Life), mortality
Comparison	Control participants were asked not to change their degree of physical activity during the active study period. Neither training participants nor controls were instructed regarding physical activity during the 6‐month extended follow‐up
Country and setting	Sweden Single centre
Follow‐up	10 months (after randomisation)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Outcome assessors blinded. Participants, clinical carers not blinded
Selective reporting (reporting bias)	Low risk	All outcomes described in methods reported in results
Intention‐to‐treat analysis?	Low risk	Although ITT not implicit, it appears that groups are analysed according to original randomised allocation
Incomplete outcome data?	High risk	Outcome available in only 43/54 (80%) participants randomised at 10 months' follow‐up. No imputation or sensitivity analysis undertaken to assess effect of loss to follow‐up. Authors state that participants available at 10 months' follow‐up are representative
Groups balanced at baseline?	Low risk	"There was no difference between training (n =22) and control (n =27) patients as regards baseline variables"
Groups received same intervention?	Low risk	"No change in medication allowed during study"