Methods | Single-centre open RCT in Finland | |
Participants |
N Randomised: Total: 228 (201 males, 27 females); EX: 119 (104 males, 15 females) UC: 109 (97 males, 12 females) Baseline Characteristics: Previous unstable angina (%): EX: 29; UC: 31 Previous MI (%):EX: 42; UC: 46 Hypertension (%):EX 31;UC 23 LVEF (%):EX: 70.3 (SD 11.5); UC: 71.4 (SD 12.3) Age (years): EX: 54.1 (SD 5.9); UC: 54.3 (SD 6.2) Percentage male:88% Percentage white: Not reported Inclusion/exclusion criteria: Inclusion: patients who underwent elective CABS Exclusion: any other serious disease; ?65 years of age |
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Interventions | 4 stage rehab over 30 months starting pre CABG with meeting of physician, psychologist and OT/PT. 6-8 weeks post CABG - 3 weeks IP with group sessions with psychologist, aerobic physical activity, relaxation & group discussion. 8 months post CABG - 2 days meeting with OT, nutritionist, physician, physio. 30 months post CABG - one day with nutritionist, physician & exercise. |
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F/U I year & 6 years Usual care: no further details |
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Outcomes | Mortality, CABG, health-related quality of life: Nottingham Health Profile | |
Notes | 5 years after CABG only 20% of participants were working, despite 90% of patients being in functional classes 1-2. Almost half of patients had retired pre CABG. Many other factors affect RTW post CABG - age, education, physical requirements of the job, type of occupation, self employed status, non work income, personality type, self perception of working capacity and mostly length of absence from work pre CABG | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes |
High risk | “open randomised trial” Data on deaths &admissions from the hospital records department |
Incomplete outcome data (attrition bias) All outcomes |
High risk | 13% lost to follow up, no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Unclear risk | No information reported. |