Barakat 2016.
Study characteristics | ||
Methods | Study design: single‐centre, prospective RCT Number of participants: 136 people were randomised Exclusions post‐randomisation: 12 participants (6 from each group) withdrew from the study before operative interventions as their procedures were cancelled or postponed Losses to follow‐up: no participants were lost to follow‐up Intention‐to‐treat analysis: study authors report ITT analysis was performed but that 12 participants (6 in each group) withdrew because their procedures were cancelled or postponed. Duration/dates study conducted: September 2009 to January 2014 |
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Participants | Country: UK Setting: tertiary vascular surgical centre Age: 73.4 (SD 7.2); intervention = 73.8 (6.5), control = 72.9 (7.9) Sex: 111 men and 13 women Inclusion criteria: people scheduled for elective open or endovascular repair; older than 18 years; AAA ≥ 5.5 cm in maximum diameter; able to give informed written consent Exclusion criteria: presence of factors that may limit exercise participation, such as; severe musculoskeletal disorders; those requiring expedited or urgent aneurysm repair; thoracic aortic aneurysms |
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Interventions | Intervention group (and sample size): n = 62 Supervised exercise group. Hospital‐based exercise classes, carried out 3 times a week, for 1‐hour duration, in the physiotherapy gym, for 6 consecutive weeks. The scheduled exercise program was for a total of 6 consecutive weeks immediately preceding the intended operation date. Each exercise class consisted of the following: 5‐minute warm up and stretching, cycle ergometer against moderate resistance for 2 minutes, heel‐raise repetitions for 2 minutes, knee extensions against resistance repetitions for 2 minutes, dumbbells biceps/arm curls repetitions for 2 minutes, step‐up lunges repetitions for 2 minutes, knee bends (bodyweight) repetitions for 2 minutes, and 5 minutes for cool down and stretching. Between each of the exercise stations, participants either walked around the gym or on a treadmill, or rested for 2 minutes before moving on to the next exercise. Control group (and sample size): n = 62 Standard treatment, i.e. "Patients allocated to the control group were clearly instructed to continue with their normal lifestyle, and avoid any additional, unsupervised exercises" |
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Outcomes | Primary outcome: composite endpoint of cardiac, pulmonary, and renal complications Secondary outcome: 30‐day mortality; lengths of hospital and critical care stay; Acute Physiology and Chronic Health Evaluation II (APACHE II) scores; reoperation; postoperative bleeding |
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Notes | The authors did not receive any funding. Declaration of interest study authors: "No competing interests have been declared." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence prepared by an independent professional. |
Allocation concealment (selection bias) | Low risk | Randomisation was performed using opaque, sealed, identical envelopes containing the treatment allocation, according to a computer‐generated sequence prepared by an independent professional. Participants were randomised into one of the two groups: the exercise (intervention) group or the standard treatment (control) group. The randomisation process was witnessed by an independent research professional and was carried out during the initial visit after obtaining informed consent, but before preoperative assessments and interventions. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Clinicians including consultant surgeons, anaesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to participant group allocation. Due to the nature of the intervention it is not possible to blind participants and this score is for personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study reported that personnel were blinded, but did not state whether outcome assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost to follow‐up |
Selective reporting (reporting bias) | High risk | Protocol stated that they would measure quality of life scores, but this was not reported in the paper. The paper reported APACHE II scores, reoperation, and postoperative bleeding, which were not outcomes listed in the protocol. |
Other bias | Low risk | No evidence of other bias. |