| Methods | RCT parallel group | |
| Participants | n = 90 pts in Home-based CR group; n = 90 pts in Centre-based CR group; 100% MI; mean age 69 (SD 1.6); 71% male Inclusion: age >45 y, MI Exclusion: Severe cognitive impairment; physical disability; left ventricular ejection fraction <35%; contraindications to vigorous exercise; eligibility for myocardial revascularisation, living too far from CR unit |
|
| Interventions |
Home-based CR (intervention): Exercise: Overall duration; 8-wks; Frequency: 3 days/wk; Duration: 1-hour; Intensity 7085% peak HR; Modality: cycle ergometer. Physical therapist home visits every other week Other: monthly family-oriented support groups Centre-based CR (control): Exercise: Overall duration; 12-week programme; Frequency: 3 days/wk; Duration: not reported; Intensity 70-85% peak HR; Modality: cycle ergometer. Trans-telephonic ECG monitoring during exercise Other: risk factor management counselling; support group meetings |
|
| Outcomes |
Primary: Total work capacity (TWC) Secondary: Health-related quality of life (Sickness Impact Profile, SIP), mortality, morbidity (cardiovascular events), healthcare utilisation (medical visits, rehospitalisations), costs & adherence (number of completed training sessions) |
|
| Follow up | 2, 8 & 14 months post randomisation | |
| Subgroup analyses | Subgroup analysis in age groups (middle-aged 45-65 years, old 65-75 years, very old >75 years) | |
| Country & settings | Italy, single hospital centre | |
| Notes | Data presented separately for 3 age groups. Follow up data on charts only; authors contacted for numerical data at follow up & these have been supplied for TWC & SIP separately for 3 groups; data pooled across age groups by reviewers | |
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Not reported |
| Allocation concealment? | Unclear risk | Not reported |
| Blinding? All outcomes |
Low risk | “Testing personnel were blinded to patient assignment.” |
| Incomplete outcome data addressed? All outcomes |
Low risk | “we performed a sensitivity analysis comparing results obtained with and without replacement of missing data with data obtained with the expectation-maximization imputation method. Because the 2 analyses provided similar results, which were also similar with missing data substituted with data estimated in a worst-case scenario, only the data from patients who completed the study are presented |
| Free of selective reporting? | Low risk | All outcomes described in the methods section are reported in the results |
| Groups balanced at baseline? | Low risk | “baseline sociodemographic and clinical characteristics were similar across the 3 arms of the trial” Baseline characteristics by home and hospital group allocation not reported in tabular format |
| Intention to treat analysis? | Low risk | Although term ‘intention to treat analysis’ was not stated directly, on the basis of CONSORT diagram presented, the groups did appear to be analysed according to original random allocation |
| Groups received same intervention? | Low risk | |