Reid 2012.
Study characteristics | ||
Methods |
Study design: multicentre RCT (2 sites) Country: Canada Dates participants recruited: December 2004 to December 2007 Maximum follow‐up: 12 months |
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Participants |
Inclusion criteria: Admitted for acute coronary syndromes who: underwent successful percutaneous coronary revascularisation; were not planning on enrolling in CR; had Internet access at home or work; and were 20 to 80 years of age. Exclusion criteria: CABG; implantable cardioverter‐defibrillator; NYHA Class III or IV heart failure; inability to speak and read English. N randomised: total: 223 ; intervention: 115; comparator: 108 Diagnosis (% of participants): AMI this admission: 29.1% PCI this admission: 98.2% First cardiac event: 64.6% Previous AMI: 18.8% Previous PCI: 27.4% Previous CABG: 9.0% Age (mean ±SD): intervention: 56.7 ± 9.0; comparator: 56.0 ± 9.0 Percentage male: intervention: 82.6%; comparator: 86.1% Ethnicity: NR |
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Interventions |
Intervention: Participants were visited in hospital by an exercise specialist, who presented a personally tailored physical activity plan and instructions on how to access the CardioFit website. Following discharge, participants were asked to log their daily activity on the CardioFit website and complete a series of five online tutorials (at weeks 2, 4, 8, 14, and 20). Following each tutorial, a new physical activity plan was developed. Between tutorials, participants received emails from the exercise specialist providing motivational feedback on their progress. Components: exercise plus psychological support Setting: home Exercise programme modality: NR Length of session: NR Frequency: NR Intensity: NR Resistance training included? NR Total duration: 20 weeks Co‐interventions: the CardioFit website and tutorials were designed to foster behavioural capability, self‐efficacy, social support, and realistic outcome expectations. Tutorials were organised to engage self‐control processes including exercise planning, goal setting, monitoring and self‐regulation, and relapse prevention. Comparator: physical activity guidance from their attending cardiologist and an education booklet. Co‐interventions: none described |
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Outcomes | HRQoL | |
Source of funding | Heart and Stroke Foundation of Ontario. Dr Reid was supported by a New Investigator Award from the Heart and Stroke Foundation of Canada. Dr Blanchard is supported by the Canada Research Chairs programme. | |
Conflicts of interest | "The authors declare that there is no conflict of interests" | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were randomized ... using a random sequence that was computer generated by a statistical consultant in blocks of 4, 8, and 10." |
Allocation concealment (selection bias) | Low risk | "Sequences were generated for Ottawa and London and placed in sealed, numbered envelopes to ensure that treatment allocation was concealed until after baseline data collection. Research coordinators allocated the next available number on study entry (while the participant was still hospitalized)" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Research assistants, blinded to the participants’ treatment allocation, conducted follow‐up assessments" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up was well reported but was high in both groups 36/115 [31%] and 33/108 [31%] were lost to follow‐up from the intervention and control groups. |
Selective reporting (reporting bias) | Low risk | All outcomes described in the methods section are reported in results. |