Wall 2010

Methods	Parallel group RCT
Participants	N Randomised: 19 (exercise 9; control 10) Diagnosis (% of participants): Aetiology: not reported NYHA: mean: exercise 2 (SE 0); control 2.13 (SE 0.13) LVEF: ≤ 60% Case mix: as above Age (yr): exercise 69 (SD 4.44); control 70 (SD 4.05) Male: 58% White: 100% Inclusion/exclusion criteria Inclusion: 1. a diagnosis of NYHA Class I‐III congestive HF, 2. an EF ≤ 60%, 3. systolic dysfunction, 4. physician approval and 5. the ability to complete a minimum of 3 min of a modified Bruce‐protocol stress test Exclusion: failure to meet any of the inclusion criteria, inability to speak English or having noticeable cognitive impairment
Interventions	Exercise:Total duration: 12 months Aerobic/resistance/mix: aerobic Frequency: 3 sessions/wk Duration: > 15 min Intensity: not reported Modality: treadmill Lifestyler® treadmill provided for 1 year of in‐home use, 3 supervised exercise sessions at hospital with CR specialist. Weekly in‐home exercise visits with CR specialist, Month 1. Monthly in‐home exercise visits with CR specialist, Months 2‐12. Also received comprehensive disease management programme Setting: 3 hospital based and the remainder at home Other: not reported
Outcomes	Disease‐specific HRQoL (Chronic Heart Failure Questionnaire), mortality
Comparison	Comprehensive disease management ‐ by dedicated case manager (participant education on nutrition, medications, and disease management; an oximetry assessment; and constant monitoring of symptomatic changes and disease status
Country and setting	USA Single‐centre
Follow‐up	12 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	Unclear risk	Not reported
Selective reporting (reporting bias)	Low risk	All outcomes described in methods reported
Intention‐to‐treat analysis?	Low risk	Although not stated, it is clear from CONSORT diagram that 2 groups were analysed according to ITT
Incomplete outcome data?	Low risk	QUORUM flow diagram report suggests 19 were included in the analysis 15 participants (79%) completed final follow‐up measures at month 12
Groups balanced at baseline?	Low risk	Table 3 of the publication suggests there is no difference between the 2 groups (except dyspnoea score)
Groups received same intervention?	Low risk	Both groups received comprehensive disease management