Davidson 2010

Methods	Parallel group RCT
Participants	N Randomised: 105 (exercise 53; control 52) Diagnosis (% of participants): Aetiology: not reported NYHA: Class I: exercise 2%; control 0%; Class II: exercise 38%; control 33%; Class III: exercise 60%; control 67%; Class IV: exercise 0%; control 0% LVEF: not reported Case mix: as above Age (yr): exercise 71.6 (SD not reported); control 73.9 (SD not reported) Male: 67% White: not reported Inclusion/exclusion criteria Inclusion: participants were of any age with a diagnosis of HF of any aetiology, and NYHA Class I‐IV. All participants cleared by their physician to participate in the exercise group Exclusion: participants with unstable angina pectoris were ineligible to participate
Interventions	Exercise:Total duration: 12 wk Aerobic/resistance/mix: aerobic Frequency: 1 session/wk Duration: 30‐50 min Intensity: not reported Modality: gymnasium: treadmills, stationary cycles, recumbent cycles Home‐based: hall walks, stairs and sporting activities such as lawn bowls Setting: supervised gymnasium, home‐based programme tailored to participant's need Other: also attended a nurse‐coordinated CR clinic with emphasis of self‐management. A group‐based educational session was conducted for study participants and their families. Exercise group attended the nurse‐co‐ordinated CR clinic, where comprehensive assessment was performed by the physiotherapist, CR co‐ordinator and occupational therapist
Outcomes	HRQoL (MLWHFQ), all‐cause and cardiovascular‐related hospital admission, mortality
Comparison	Information session and then usual medical care
Country and setting	Australia Single‐centre
Follow‐up	12 months (after randomisation)
Notes	The trial had to be stopped prematurely at 12 months following introduction of chronic and complex care for people with CHF by the New South Wales Health Department. "In view of trends in favour of the intervention group and emerging evidence from other studies, it was considered unethical and untenable to continue randomization in view of the policy mandate. When the trial was stopped there were 53 participants in the intervention group and 52 participants in the usual care group"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Participants were randomized to either the intervention or control group by means of a computer‐generated program"
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	"The randomization technique was blinded to the investigators until the close of the study"
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	"No participants were lost to follow‐up"
Groups balanced at baseline?	Low risk	"…there were few differences between intervention and usual care groups, indicating success of randomization. The most important difference on clinical variable was that a significantly greater proportion of people in the intervention group were taking spironolactone at baseline"
Groups received same intervention?	Low risk	Both groups appeared to receive same interventions apart from CR intervention