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. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3

Houle 2012.

Methods Study design: Multicentre RCT (2 sites)
Country: Canada
Dates patients recruited: April 2007 to April 2008
Maximum follow up: 12 months
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
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.
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”