| Methods | RCT parallel group | |
| Participants | n = 263 pts in Home-based CR group; n = 262 pts in Centre-based CR group; diagnosis: MI 256 pts; PTCA 211 pts; CABG 56 pts; mean age 61 (SD 10.8); 77% male; 80.2% white Inclusion: an acute MI, coronary angioplasty (±stenting) or CABG Exclusion: inability to speak either English or Punjabi, dementia, severe hearing impairment, sight defects of sufficient severity to prevent them from reading the Heart Manual & serious persisting complications |
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| Interventions |
Home-based CR (intervention) - Heart Manual: Exercise: Overall duration: 6 wks Heart Manual programme & 12 wks nurse support; frequency: up to daily; Duration: not reported; intensity: not reported; modality: walking Other: education on risk factors, lifestyle changes, medications & stress management (relaxation tapes) Centre-based CR (control): Exercise: Total Duration: 6-12 wks; Frequency: 1 or 2 sessions/wk; duration:25-30mins/session; intensity: 65-75% HRmax; modality: circuit training, cycle ergometer Other: education & stress management (relaxation) |
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| Outcomes |
Primary: Serum cholesterol, total, HDL-cholesterol, blood pressure, exercise capacity (incremental shuttle walking test, ISWT), smoking cotinine-validated) Secondary: quality of life (EQ-5D), health service utilisation (hospital readmissions, primary care visits, medication) Mortality, cardiovascular events, costs |
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| Follow up | 6, 12 & 24 months | |
| Subgroup analyses | Yes. “Interaction terms between these factors [diagnosis (MI/revascularisation), age, sex and ethnicity] and rehabilitation setting were included to investigate possible differences in treatment effect between subgroups of patients. ” | |
| Country & settings | UK, 4 hospital centres | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Adequate sequence generation? | Low risk | “Patients who consented to randomisation were randomised on an individual basis with minimisation by (1) original diagnosis (MI/revascularisation), (2) age (<50/50-74/75+ years), (3) sex, (4) ethnicity (Caucasian/Asian/other) and (5) hospital of recruitment. ” |
| Allocation concealment? | Low risk | “Allocation was undertaken by the Birmingham Cancer Clinical Trials Unit, a group that was independent from the trial team …When a patient agreed to be randomised, …the research nurse telephoned the Clinical Trials Unit, …and was given an allocation group. ” |
| Blinding? All outcomes |
Low risk | “Assessments were blinded, with follow-up undertaken by a research nurse who had neither recruited the patient nor provided home CR support.” |
| Incomplete outcome data addressed? All outcomes |
Low risk | “A sensitivity analysis was undertaken on the 12-month data to assess the potential impact of the missing values for the ISWT, SBP, DBP, TC and the HADS scores. ” |
| Free of selective reporting? | Low risk | All outcomes described in the methods section are reported in the results |
| Groups balanced at baseline? | Low risk | “Demographic characteristics, diagnosis, past medical history and cardiac risk factors were well matched between the two arms at baseline.” |
| Intention to treat analysis? | Low risk | “All data were analysed by intention-to-treat (ITT). ” |
| Groups received same intervention? | High risk | Although both groups received exercise, education and stress management, the nature and amount of intervention between groups was different |