West 2012.
Methods |
Study design: Multicentre RCT (14 sites) Country: England and Wales, UK Dates patients recruited: August 1997 to April 2000 Maximum follow up: 7 to 9 years |
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Participants |
Inclusion criteria: Admission to hospital with a principal primary diagnosis of acute MI (two of the three standard criteria ‘typical history’, electrocardiographic features and cardiac enzymes), discharged home within 28 days, local resident and able to give informed consent with no age or gender restrictions. Exclusion criteria: Physical frailty, mental confusion, serious co‐existing disease, communication difficulty, previous cardiac rehabilitation and discharged to hospice or another hospital. N Randomised: total: 1813; intervention: 903; comparator: 910 Diagnosis (% of pts): Acute MI: 100% Age (mean ± SD): intervention: 64.2 ± 11.2; comparator: 64.7 ± 10.9 Percentage male: intervention: 72.6%; comparator: 74.4% Ethnicity: NR |
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Interventions |
Intervention: Exercise training was the largest component, typically occupying half of the available time including warm up and cool down, and used exercise equipment in physiotherapy gyms. Relaxation was primarily physical following ‘cooling down’ from exercise with little or no ‘stress management’ training. Components: exercise plus education plus psych. Setting:centre‐based supervised programmes which varied centre. Aerobic exercise: Modality: varied by centre. Length of session: averaged 20 hours over 6‐8 weeks. Frequency: weekly or bi‐weekly. Intensity: NR Resistance training included? NR Total duration: 6‐8 weeks. Co‐interventions: The programmes comprised exercise training, health education about heart, heart disease, risk factors and treatment, counselling for recovery and advice for long‐term secondary prevention. All involved at least one other discipline (exercise physiologist, dietician, pharmacist, health promotion specialist, psychologist, counsellor, social worker, physician and/or cardiologist). Comparator: All patients in the trial (and in the ‘elective hospitals’ comparison) had similar care in all respects other than referral to cardiac rehabilitation, receiving available explanatory booklets, being advised to see their general practitioner (GP) and attend routine outpatient follow‐up, with referral for further cardiac investigations or interventions as appropriate. Co‐interventions: none described. |
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Outcomes | Mortality, MI, revascularisations, hospitalisation, HRQL. | |
Source of funding | NHS Research and Development Programme (northern region) and the Heart research fund for Wales. | |
Conflicts of interest | None declared. | |
Notes | An additional 331 patients were entered in two matched pairs of ‘elective rehabilitation’ and ‘elective control’ hospitals; 197 to rehabilitation and 134 to control. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Patients were randomised centrally” – it does not state how. |
Allocation concealment (selection bias) | Low risk | “Patients were randomised centrally on a preset protocol, daily and blind as to entry characteristics and baseline measures, …..The names of those randomised to rehabilitation were passed to the local programme coordinator”. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Secondary outcomes were assessed at 1 year….blind to rehabilitation status”. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5% lost to FU from each group (2 year interviews); “follow‐up interviews were completed in 95% of surviving patients in both groups” |
Selective reporting (reporting bias) | Low risk | All outcomes reported for all time points. |
Groups balanced at baseline | Low risk | “At baseline, patients randomised to rehabilitation and controls were well matched on personal characteristics, clinical histories and lifestyle habits .“ |
Intention‐to‐treat analysis conducted | Low risk | Analysis is by ‘intention to treat’. |
Groups received same treatment (apart from the intervention) | High risk | "The programmes comprised exercise training, health education about heart, heart disease, risk factors and treatment, counselling for recovery and advice for long‐term secondary prevention". |