Houle 2012.
Study characteristics | ||
Methods |
Study design: multicentre RCT (2 sites) Country: Canada Dates participants recruited: April 2007 to April 2008 Maximum follow‐up: 12 months |
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Participants |
Inclusion criteria: participants hospitalised for an ACS (unstable angina, non‐ST–elevation or ST elevation myocardial infarction) and willing to travel to the CR centre every 3 months to meet the clinical nurse specialist and able to read and speak French Exclusion criteria: inability to perform activities of daily living (such as feeding themselves, bathing, dressing, grooming, work, homemaking and leisure); enrolment in another research project or in a heart failure clinic where serial follow‐up creates a bias and contraindication to exercise testing; medical diagnosis of debilitating chronic illness (such as cancer without remission), musculoskeletal or neurological disorder (such as multiple sclerosis, Parkinson's disease, etc.); people with a previous history of stroke could be included if they had no residual effects related to their stroke); serious and unstable mental incapacities or major depression N randomised: total: 65; intervention: 32; comparator: 33 Diagnosis (% of participants): Unstable angina: intervention: 50%; comparator: 52% STeMI: intervention: 28%; comparator: 27% Non STeMI: intervention:22%; comparator: 21% Age (mean ± SD): intervention: 58 ± 8; comparator: 59 ± 9 Percentage male: total: 78%; intervention: 81%; comparator: 76% Ethnicity: NR |
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Interventions |
Intervention: participants received a pedometer‐based programme concomitantly with a socio‐cognitive intervention led by a clinical nurse specialist. Participants used 1 pedometer blinded and used a second one to monitor their daily steps since discharge. Components: exercise plus education plus socio‐cognitive intervention Setting: home Exercise programme modality: walking Length of session: not specified Frequency: not specified Intensity: not specified Resistance training included? No Total duration: 12 months Co‐interventions: participants received a socio‐cognitive intervention led by a clinical nurse specialist, and a blinded pedometer with instructions about how to wear the pedometer correctly during 7 consecutive days from morning to bedtime. Comparator: participants received the usual advice by the nurse or the physician, or both, at discharge regarding physical activity, diet and medication. They had no restriction to go to a centre‐based cardiac rehabilitation programme or to consult a health care professional such as a nutritionist, an exercise specialist or a psychologist. Participants in both groups received usual medical follow‐up by their own physicians (cardiologist and family physician). Co‐interventions: participants received a blinded pedometer and instructions about how to wear the pedometer correctly during 7 consecutive days from morning to bedtime. |
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Outcomes | HRQoL | |
Source of funding | Heart and Stroke Foundation of Canada, Research centre of Institut Universitaire de Cardiologie et Pneumologie de Québec, and Pfizer Canada | |
Conflicts of interest | "Authors had no conflict of interest to declare". | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "They were randomly allocated to the experimental group or to the usual care group using a randomization table". |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Physical activity recorded by a blinded pedometer. However, blinding of assessors of other tests and measurements not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up was high in both groups: 9/32 (28%) and 11/33 (33%) were lost to follow‐up from the intervention and control groups. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported at all time points described either in the paper or in the supplementary material online. |