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

Oerkild 2012.

Methods Study design: Single centre RCT
Country: Denmark
Dates patients recruited: January 2007 to July 2008.
Maximum follow up: 12 months; mortality data after 5.5 years (mean follow‐up 4½ years).
Participants Inclusion criteria: Patients ≥ 65 years with a recent coronary event defined as acute myocardial infarction (MI), percutaneous transluminal coronary intervention (PCI) or coronary artery bypass graft (CABG) and who declined participation in centre‐based CR.
Exclusion criteria: Mental disorders (dementia), social disorders (severe alcoholism and drug abuse), living in a nursing home, language barriers or use of wheelchair.
N Randomised: total: 40; intervention: 19; comparator: 21
Diagnosis (% of pts):
Previous MI: intervention: 31.7; comparator: 38.1
Previous PCI: intervention: 21.1; comparator: 23.8
Previous CABG: intervention: 0; comparator: 9.5
Heart failure LVEF ≤45%: intervention: 50.0; comparator: 42.9
Event prior to entry into the study
Post‐MI without invasive procedure: intervention:0; comparator: 19.1
Post‐PCI: intervention: 84.2; comparator: 66.7
Post‐CABG: intervention:15.8; comparator: 14.3
Age (mean ± SD): intervention:77.3 ± 6.0; comparator: 76.5 ± 7.7
Percentage male: intervention: 63.2%; comparator: 52.3%
 Ethnicity: NR
Interventions Intervention: Individualised exercise programmes followed the international recommendations with 30 min exercise/day including 5–10 min warm up (e.g. slow walking) and 10 min cool‐down at a frequency of 6 days/week at an intensity of 11–13 on the Borg scale. For very disabled patients, the exercise programmes were of shorter duration but then repeated several times a day. At 4 and 5 months, a telephone call was made by the cardiologist to encourage continuous exercising and to answer any medical questions.
Components: exercise plus risk factor management.
Setting: unsupervised individualised programme at home, with telephone support.
Aerobic exercise:
Modality: individualised.
Length of session: 30 min.
Frequency: 6 days a week.
Intensity: 11–13 on the Borg scale.
Resistance training included? no.
Total duration: 12 months.
Co‐interventions: The patients consulted a cardiologist at baseline and after 3, 6 and 12 months, regarding risk factor intervention and medical adjustment. All patients were offered dietary counselling and, if required, smoking cessation.
Comparator: Patients received usual care. They received consultation with a cardiologist, and telephone calls at 4 and 5 months. They were not offered exercise education or dietary counselling.
Co‐interventions: Patients were offered risk factor intervention and medical adjustment by a cardiologist at baseline and after 3, 6 and 12 months.
Outcomes Mortality, HRQL.
Source of funding Velux Foundations.
Conflicts of interest None.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “Patients were randomised in alternated block sizes of 4–6 using computer‐generated randomly permuted blocks”.
Allocation concealment (selection bias) Low risk “An impartial person, not related to the study, randomised the patients”.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk “Because of the nature of the intervention, concealment of randomisation was not feasible with regard to both patients and researcher”. It is not clear if outcome measures are blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk “A total of nine patients died during a mean follow‐up of 4.5 years (usual care group n=5 and home group n=4). There was no loss to follow‐up.”
Selective reporting (reporting bias) High risk Although the methods state that outcomes were measured at 3, 6 and 12 months, only exercise capacity is reported at 6 months.
Groups balanced at baseline Low risk Table 1 shows groups are similar.
Intention‐to‐treat analysis conducted Low risk “Data were analysed by intention to treat”.
Groups received same treatment (apart from the intervention) Low risk "Patients were not offered exercise education or dietary counselling but, as for the home group, offered risk factor intervention and medical adjustment by a cardiologist at baseline and after 3, 6 and 12 months".