Richardson 2014.
Study characteristics | ||
Methods | Study design: single‐blinded randomised control trial Number of participants: 23 people were randomised Exclusions post‐randomisation: 0 Losses to follow‐up: abstract stated that 23 people were enrolled, but clinical trial registry posted after trial was complete stated that 21 people were enrolled Intention‐to‐treat analysis: NR Duration/dates study conducted: September 2011 to May 2015 |
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Participants | Country: UK Setting: Medway Maritime Hospital Age: NR Sex: NR Inclusion criteria: people aged > 18 years; able to give informed consent; able to comply with the study protocol; undergoing open surgical repair for an asymptomatic perirenal and infrarenal abdominal aortic aneurysm. Exclusion criteria: people with severe disabling disorders limiting mobility, e.g. severe osteoarthritis; people undergoing thoracoabdominal aneurysm surgery; people physically unable or unwilling to undertake maximal cardiopulmonary exercise testing and the other fitness tests; people younger than 18 years of age or older than 80 years of age |
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Interventions | Intervention group (and sample size): number of participants not reported. Usual care plus preoperative exercise. Cycled for 60 min at 60% VO2 peak (submaximal cycling exercise at a moderate exercise intensity) on three consecutive days immediately prior to surgery. During the 60 min of exercise, participants were provided with three equally spaced 3 min rest periods. The last exercise session was completed no more than 48 h prior to the operation. Control group (and sample size): usual care; number of participants not reported |
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Outcomes | Postoperative mortality (60‐day mortality); length of hospital stay (through study completion, on average up to 60 days postsurgery); postoperative complications as assessed by the POMS (on average up to 5 days postsurgery) ‐ pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. | |
Notes | Funding source and declaration of interests not recorded. | |
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 of participants and personnel (performance bias) All outcomes | Low risk | Care providers blinded. Due to nature of intervention, participants could not be blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Abstract stated that 23 people were enrolled, but the clinical trial registry posted after the trial was complete stated that 21 people were enrolled. No information on the numbers of participants in each study arm. |
Selective reporting (reporting bias) | Unclear risk | Trial protocol was registered on clinicaltrials.gov after the study was completed. |
Other bias | Low risk | No evidence of other bias. |