McKelvie 2002

Methods	Parallel group RCT
Participants	N Randomised: 181 (exercise 90; control 91) Diagnosis (% of participants): Aetiology: ischaemic 76%; hypertensive 7%; valvular 5%; other 12% NYHA: Class I‐III LVEF: < 40% Case mix: 100% as above Age (yr): exercise 64.8±1.1 (SD 10.5); control 66.1 (SD 9.4) Male: control 80; exercise 82 White: not reported Inclusion/exclusion criteria Inclusion: documented clinical signs and symptoms of HF; LVEF < 40%; NYHA Functional Class I‐III; 6‐min walk test distance < 500 m Exclusion: inability to attend regular exercise training sessions; exercise testing limited by angina or leg claudication; abnormal blood pressure response to exercise testing (systolic blood pressure during exercise > 250 mm Hg or diastolic blood pressure response > 15 mm Hg, systolic blood pressure response decrease of > 20 mm Hg after a normal increase or decrease below the resting level); cerebrovascular or musculoskeletal disease preventing exercise testing or training; respiratory limitation (forced expired volume in 1 second, or vital capacity < 60% of predicted, or both); poorly controlled cardiac arrhythmias and any non‐cardiac condition affecting regular exercise training or decreasing survival
Interventions	Exercise:Total duration: 9 months (3 supervised, 6 home based) Aerobic/resistance/mix: mix Frequency: 2 sessions/wk Duration: aerobic; 30 min/session Intensity: aerobic: 60‐70% max HR. Resistance: 40% of 1‐repetition maximum, with 10 repetitions for the arm exercises and 15 repetitions for the leg exercises, with an increase over 5 wk to an intensity of 60% of 1‐repetition maximum and a total of 3 sets of each exercise per session Modality: aerobic: cycle, treadmill and arm ergometry exercise. Resistance: arm curl, knee extension and leg press performed individually with each limb After 3 months of supervised training, participants in the exercise group were provided an exercise cycle and set of free weights with instructions to continue training at home 3 times/wk for the remainder of the study Setting:Supervised for 3 months at rehabilitation centre and unsupervised for 9 months at home Other: none reported
Outcomes	HRQoL (MLWHFQ), mortality, composite of mortality and hospital admission for HF
Comparison	Usual medical care. Control participants were not provided with a formal exercise prescription but were encouraged to continue their usual level of physical activity and were not discouraged from regular physical activity
Country and setting	Canada Multicentre
Follow‐up	12 months (after randomisation)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The predetermined allocation sequence was based on a stream of computer‐generated pseudorandom numbers from a uniform distribution stratified by center and with a blocking factor of 4"
Allocation concealment (selection bias)	Low risk	"Eligible patients were registered in a log and treatment group determined by opening the next sequential study allocation envelope"
Blinding (performance bias and detection bias) All outcomes	Low risk	"Outcome measures were performed in a blinded fashion. Individuals responsible for supervising and recording the results of the outcome measurements were unaware of the patients group assignment"
Selective reporting (reporting bias)	Unclear risk	All outcomes described in methods are reported in results
Intention‐to‐treat analysis?	Low risk	Although ITT analysis not reported, groups do appear to analysed according to original randomised allocation
Incomplete outcome data?	Low risk	"In the control group, 83 patients completed 3 months of follow‐up (reasons for incompletion: death 3; other problems 4; worsening heart failure 1) and 75 patients completed 12months of follow‐up (reasons for incompletion: death 8; withdrawal 2; other problems 3; worsening heart failure 2; refused testing 1) For the exercise group, 80 patients completed 3 months of follow‐up (reasons for incompletion: death 1; withdrawal 5; other problems 1; worsening failure 2; refused testing 1) and 64 patients completed 12 months of follow‐up (reasons for incompletion: death 9; withdrawal 6; other problems 7; worsening heart failure 3; refused testing 1)" No imputation or sensitivity analysis undertaken to assess impact of loss to follow‐up
Groups balanced at baseline?	Low risk	"There were no differences between the control and exercise training groups with respect to age, resting ejection fraction, New York Heart Association class, cause of heart failure, or duration of heart failure"
Groups received same intervention?	Unclear risk	"All patients were reviewed monthly throughout the study"