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. Author manuscript; available in PMC: 2014 Sep 10.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007130. doi: 10.1002/14651858.CD007130.pub2
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
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)
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
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