Dracup 2007

Methods	Parallel group RCT
Participants	N Randomised: 173 (exercise 86; control 87) Diagnosis (% of participants): Aetiology: ischaemic; idiopathic; valvular; DCM; other NYHA: Class II‐IV LVEF: 26.4 (SD 6.8) Case mix: 100% as above Age (yr): 54 (SD 12.5) Male: 71.7% White: 60.1  Inclusion/exclusion criteria Inclusion: English‐speaking, age 18‐80 yr, NYHA II‐IV and LVSD with LVEF < 40% as documented by echocardiogram or radionuclide ventriculography within < 6 months, and sinus rhythm Exclusion: MI or recurrent angina within < 3 months, orthopaedic impediments to exercise, severe obstructive pulmonary disease with a forced expiratory volume < 1 L in 1 second as measured by spirometry, stenotic valvular disease as measured by echocardiogram, history of uncontrolled ventricular tachyarrhythmias (documented by electrophysiology study or 24‐hr Holter monitor), or absence of an implantable cardioverter‐defibrillator despite a history of sudden cardiac death
Interventions	Exercise:Total duration: unclear (6 months or 1 year) Aerobic/resistance/mix: mix Frequency: 4 sessions/wk Duration: 10‐45 min Intensity: 40‐60% max HR Modality: walking Setting: home‐based Other: "After six weeks resistive training component involved both upper and lower extremity strengthening. Resistance training was prescribed at 80% of one repetition maximum, which is the maximal weight lifted one time, for 2 sets of 10 repetitions using seated biceps curls to strengthen the arms & seated lateral raises to strengthen shoulders. A second set of 10 repetitions at 80% of one repetition maximum was also prescribed…"
Outcomes	HRQoL (MLWHFQ), mortality, hospitalisation
Comparison	Maintained usual level of daily activities. No exercise component
Country and setting	USA Single centre
Follow‐up	6 and 12 months (after randomisation)
Notes	Home‐based exercise programme Subgroup analysis reported: Evangelista 2010
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	Unclear risk	Blinding reported for physical activity (accelerometer) outcome but not reported for other outcomes
Selective reporting (reporting bias)	Low risk	All outcomes described in methods reported
Intention‐to‐treat analysis?	Low risk	Although not reported as ITT analysis, groups did appear to be analysed according to original randomised allocation
Incomplete outcome data?	Low risk	"Two patients (one from the experimental and one from the control group) were lost to follow‐up within the first three months of enrollment. One was incarcerated and the second left the geographic area with no forwarding information. The remaining 173 patients compose the final study"
Groups balanced at baseline?	Low risk	Current version: "There were no differences between the control and exercise groups at baseline with respect to sociodemographic variables (Table I) and most clinical characteristics. However, patients in the exercise group had a significantly higher likelihood of having a history of coronary heart disease and taking antiplatelet medication than in the control group" Our version: "There were no significant differences in any of baseline characteristics between the 2 groups, except for angiotensin‐converting enzyme (ACE) inhibitor; adherers were more likely to use ACE inhibitors than nonadherers (84% vs 60%; P = 0.039)"
Groups received same intervention?	Low risk	"Research nurses made home visits weekly for the first two weeks and then monthly to assess protocol adherence, correct use of the pedometer, and tolerance to the exercise program. The home visits also served as a form of attention control in the care‐ as‐usual group. All clinical questions were referred to the patient's cardiologist"