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". |