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. 2019 Feb 12;2019(2):CD011828. doi: 10.1002/14651858.CD011828.pub2

Frizelle 2004.

Methods Parallel group RCT (pilot trial)
Participants N Randomised: 22 (control group (waiting list) 10; exercise group 12). None lost to follow‐up
Profile: Patients with ICD
Age: Exercise group 60.4 yeas SD 10.13 versus control group 62.8 years SD 4.66
Male: NS
White: NS
Inclusion criteria:
  • Patients that had undergone implantation of an ICD for treatment of uncontrolled ventricular arrhythmia due to chronic heat disease (included patients who had undergone coronary artery bypass graft surgery or other cardiac surgery prior to ICD implantation)


Exclusion criteria:
  • Patients who were awaiting CABG and/or heart transplantation surgery or who had recently experienced acute MI

  • Patients with idiopathic aetiology of ventricular arrhythmia;

  • Patients with other complicating medical conditions that would make co‐operation difficult or impossible

  • Patients unable to understand English

Interventions Exercise:
  • Total duration: 12 weeks

  • Aerobic/resistance/mix: a simple, low impact, self‐paced, largely home‐based exercise programme

  • Frequency: 7 days per week (for 12 week)

  • Duration: 10 minutes

  • Intensity: patients set their own baseline for how many of each set of exercises they could complete within the allocated time

  • Modality: ns

  • Setting: 6 sessions at the out‐patient clinic, rest done at home.

  • Other: psycho‐education based on cognitive‐behavioural therapy (6 group sessions face to face, 1 telephone follow up)


Control:
  • Control group received routine care including any scheduled visits to ICD patient clinics or their own doctor

Outcomes
  • Anxiety

  • Quality of life

  • Perceived health state

  • Exercise test

Country and setting England, single‐centre trial, with 6 sessions at an outpatient clinic setting; rest done in home setting
Follow‐up
  • End of intervention, no long term follow‐up because of cross‐over

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information. Waiting response from author
Allocation concealment (selection bias) Unclear risk No information. Waiting response from author
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding because of the nature of exercise‐based cardiac rehabilitation
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information. Waiting response from author
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Number and reason for dropout was described
Selective reporting (reporting bias) Unclear risk Outcome described in methods are reported in results
Performance bias Unclear risk No information about co‐intervention. Waiting response from author
Groups balanced at baseline bias Low risk No baseline difference between groups
Intention‐to‐treat analysis Low risk Analyses were conducted according to an intention‐to‐treat analysis
For‐profit bias Unclear risk No report on their source of funding