Smolis‐Bak 2017.
Methods | Parallel group RCT | |
Participants |
N Randomised: 84 (control group 43; exercise group 41). 12 patients were lost to follow‐up (control group 5, exercise group 7) Profile: SHF and NYHA III with ICD Age: 63.7+/‐9.5 years (exercise group); 61.1 +/‐9.7 (control group) Male: 36 (87.8%) (exercise group); 40 (93.0%) (control group) White: NS Inclusion criteria:
Exclusion criteria:
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Interventions |
Exercise:
Control:
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Outcomes |
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Country and setting | Poland. Single‐centre trial, with an outpatient setting | |
Follow‐up |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Patients were randomly allocated, but there is no information on how this was done. |
Allocation concealment (selection bias) | Unclear risk | No information on concealment |
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 |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reasons for dropouts and withdrawals were not described. There was no information about any methods being used to handle missing data. |
Selective reporting (reporting bias) | Low risk | Outcome described in methods are reported in results. |
Performance bias | Low risk | Co‐intervention was delivered equally to both groups |
Groups balanced at baseline bias | Low risk | Patients well matched at baseline |
Intention‐to‐treat analysis | Low risk | Analyses were conducted according to an intention‐to‐treat analysis |
For‐profit bias | Low risk | Reported on their source of funding with conflicts of interest |
CHF: systolic heart failure; CRT: cardiac resynchronisation therapy; CRT‐D: cardiac resynchronisation therapy with defibrillator; CRT‐P: cardiac resynchronisation therapy with pacing; ESC: European Society of Cardiology; HF: heart failure; ICD: implantable cardioverter defibrillator; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; NS: not stated; QoL: quality of life; RCT: randomised controlled trial; SD: standard deviation; SF‐36: Short Form‐36 Health Survey; SHF: systolic heart failure; TIA: transient ischaemic attack; QRS: QRS complex; VF: ventricular fibrillation; VO2: estimated oxygen consumption; VT: ventricular tachycardia.