Norman 2012

Methods	Parallel group RCT
Participants	N Randomised: 42 (exercise 22; control 20) Diagnosis (% of participants): Aetiology: ischaemic 50%; non‐ischaemic 50% NYHA: Class II: exercise 64%; control 45%; Class III: exercise 36%; control 55% LVEF: exercise: mean 33% (SD 7); control: mean 32% (SD) Age (yr): exercise 57 (SD 12); control 63 (SD 15) Male: 57.5% White: not reported Inclusion/exclusion criteria Inclusion: age ≥ 21 yr, with HF; orientated to person, place and time; able to speak and read English; resting LVEF ≤ 40% and stable on optimal medical therapy for at least 30 days Exclusion: clinical evidence of decompensated HF, unstable angina pectoris, MI, coronary artery bypass surgery, biventricular pacemaker < 3 months ago, orthopaedic or neuromuscular limitations preventing participation in aerobic or resistance exercise training, and participation in an aerobic exercise programme during the past 12 months
Interventions	Exercise:Total duration: 24 wk Aerobic/resistance/mix: mix Frequency: aerobic 3 days/wk, resistance 2 days/wk Duration: aerobic: 30 min/session (30 min warm‐up); resistance: 8‐10 exercises (upper and lower extremity) performed for 1 set of 10‐15 repetitions Intensity: aerobic: 40‐70% HR reserve, or Borg 11‐14; resistance: not reported Modality: aerobic: not reported; resistance: weight machines, free weights or elastic bands based on their exercise performance Setting: 3 wk: supervised; 21 wk: hospital's wellness centre or home Other: group meetings that addressed the same education topics as the control group but in addition included information on problem‐solving barriers to exercise, relapse management and symptoms experienced during exercise
Outcomes	HRQoL (KCCQ), SF‐36 and mortality
Comparison	"Attention control" Instructions to continue with their normal level of activity. No instructions were given to withhold or stop activity
Country and setting	USA Single centre
Follow‐up	24 wk (after randomisation)
Notes	Study conducted in 2 sequential 12‐wk phases Phase 1: separate weekly group meetings of both groups during wk 1‐3, then separate biweekly meetings during wk 4‐12 Phase 2: following the groups for an additional 12 wk without group sessions Other trial report: Pozehl B, Duncan K, Hertzog M, Norman JF. Heart failure exercise and training camp: effects of a multicomponent exercise training intervention in patients with heart failure. Heart Lung 2010;39(6 Suppl):S1‐13
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	High risk	"Research assistants who were blinded to group assignment assisted in some of the data collection. However, because of budget constraints, the investigators who were not blinded to group assignment were also involved in data collection"
Selective reporting (reporting bias)	Low risk	All outcomes described in methods reported in results
Intention‐to‐treat analysis?	Low risk	Not stated but groups analysed according to randomised allocation
Incomplete outcome data?	Low risk	Due to mortality and drop out KCCQ scores available in 37 patients (88%) at 24 wk
Groups balanced at baseline?	Low risk	"…no significant difference noted between groups"
Groups received same intervention?	Low risk	Both groups received group sessions (attention control) so only difference between groups was exercise based intervention