Houle 2012.
Methods |
Study design: Multicentre RCT (2 sites) Country: Canada Dates patients recruited: April 2007 to April 2008 Maximum follow up: 12 months |
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Participants |
Inclusion criteria: Patients 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); subjects 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 pts): 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. Aerobic exercise: 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 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: Patients 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. Subjects 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 | HRQL | |
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. |
Groups balanced at baseline | Low risk | “Group characteristics were comparable (Table 1).” |
Intention‐to‐treat analysis conducted | Low risk | “The data was analyzed using an “intention to treat” approach.” |
Groups received same treatment (apart from the intervention) | Low risk | “Subjects in both groups received usual medical follow‐up by their own physicians (cardiologist and family physician) and…… received a blinded pedometer and instructions about how to wear the pedometer correctly during 7 consecutive days from morning to bedtime” |