Methods | Single-center, unblinded, single-centre RCT in China; f/u 2 y | |
Participants | 269 patients (76% men; mean age 64 y) with recent AMI (n=193) or after elective percutaneous coronary intervention (n=76) EX: n=181 (mean age, 64 SD 11 y; 138 males, 43 females) UC: n=88 (mean age, 64 SD 11 y; 66 males, 22 females) |
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Interventions | EX : Phase 1 was impatient ambulatory program that lasted 7-14 d; phase 2 was 16-session, twice weekly, outpatient exercise and education program lasting for 8 weeks, each session included 1 hr of education class followed by 2 hrs of exercise training, 1st hour oftraining was conducted by physiotherapist; phase 3 was community-based home exercise program for another 6 mos; phase 4 was long-term follow-up program until end of 2 years which stressed importance of regular exercise and risk factor modification UC: attended 2-hr talk that explained CHD, importance of risk factor modification, and potential benefits of physical activity, but without undergoing outpatient exercise training program |
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Outcomes | Total mortality | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “randomized” |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | “The QOL assessments were performed on all patients in all 4 phases by a trained social worker who was unaware of the randomization” Unclear in terms ofassessment ofother outcomes. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | 24 % lost to follow up, no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Unclear risk | No information reported. |