Jolly 2009

Methods	Parallel group RCT
Participants	N Randomised: 169 (exercise 84; control 85) Diagnosis (% of participants): Aetiology: data not available NYHA: Class I 6%; Class II 74%; Class III 20% LVEF: ≤ 40% Age (yr): exercise 65.9 (SD 12.5); control 70 (SD 12.5) Male: 75% White: 85.1% Inclusion/exclusion criteria Inclusion: LVEF ≤ 40% on echocardiogram and had a severity of at least NYHA group II in the previous 24 months. They had to have been clinically stable for 4 wk and in receipt of optimal medical treatment and in care of a specialist HF nurse team from 2 acute hospital trusts and 1 primary care trusts and not considered high‐risk for a home‐based exercise programme Exclusion: NYHA Class IV, MI or revascularisation within the past 4 months, hypotension, unstable angina, ventricular or symptomatic arrhythmias, obstructive abortive valvular disease, COPD, hypertrophic obstructive cardiomyopathy, severe musculoskeletal problems preventing exercise, and case‐note reported dementia or current severe psychiatric disorder
Interventions	Exercise:Total duration: 6 months programme progressive with aim that participants achieved the following: Aerobic/resistance/mix: mix Frequency: 5 times/wk Duration: 20‐30 min Intensity: 70% of peak VO2 or Borg 12‐13 Modality: aerobic and resistance elements (upper and lower limb exercises) Setting: first 3 sessions supervised centre‐based followed by home‐based programme with home‐visits by nurse at 4, 10 and 20 wk and telephone support at 6, 15 and 24 wk. Intervention manual provided Other: specialist HF nurse care
Outcomes	HRQoL (MLWHFQ), composite of death, hospital admissions, generic quality of life (EQ‐5D)
Comparison	Specialist HF nurse care
Country and setting	UK West‐midlands, community
Follow‐up	6‐ and 12‐month follow‐up (after randomisation)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"An independent clinical trials unit using a computerized programme undertook randomization after each patient had consented and undergone the baseline tests and questionnaire"
Allocation concealment (selection bias)	Low risk	"An independent clinical trials unit using a computerized programme undertook randomization after each patient had consented and undergone the baseline tests and questionnaire"
Blinding (performance bias and detection bias) All outcomes	High risk	"…, the nurse undertaking the assessment was blinded to the treatment allocation of the patient, but owing to staffing issues, this occurred in only 62% of participants followed up at 6 months"
Selective reporting (reporting bias)	Low risk	All of primary and majority of secondary outcomes described in methods reported Stated in methods that blood pressure and incremental shuttle walking test were not collected at 12 months
Intention‐to‐treat analysis?	Low risk	"...between‐ and within‐group analyses for primary and secondary outcomes at 6 and 12 months were performed according to intention to treat"
Incomplete outcome data?	Low risk	Drop‐outs and clinical events are fully reported Outcome available for 161 (95%) participants at 6 months and 157 (92%) participants at 12 months. Non‐imputed data reported and sensitivity analysis undertaken to examine impact of missing data
Groups balanced at baseline?	Unclear risk	"Baseline characteristics were broadly comparable, the exception being that the exercise group was somewhat younger and had higher HADS depression scores and a lower systolic blood pressure"
Groups received same intervention?	Low risk	"Both groups received specialist heart failure nurse input in primary and secondary care through clinic and home visits that included the provision of information about heart failure, advice about self‐management and monitoring of their condition, and titration of beta‐blocker therapy"