Zhang 2018.
| Study characteristics | ||
| Methods |
Study design: single‐centre RCT Country: China Dates participants recruited: January 2010 ‐ December 2012 Maximum follow‐up: 6 months |
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| Participants |
Inclusion criteria: participants admitted to the outpatient clinic after successful PCI for ST‐segment elevated MI between January 2010 and December 2012. Exclusion criteria: A large area of myocardial infarction, heart failure, acute systemic illness, systolic BP > 180 mmHg at rest, diastolic BP > 110 mmHg at rest, acute metabolic disorders, uncontrolled malignant arrhythmia, and skeletal vascular disease. N randomised: total: 130; intervention: 65; comparator: 65 Diagnosis (% of participants): post‐PCI for STEMI (100%). Age (mean ± SD): intervention: 70.3 ± 10.7; comparator: 69.8 ± 10.4 Percentage male: intervention: 59 (90.8%); comparator: 54 (83.1%) Ethnicity: NR |
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| Interventions |
Intervention: GP formulated individual aerobic exercise program that could be performed in the participants' homes or at specialised rehabilitation facilities in the community. Phase II CR optimally initiated within 2 weeks of discharge (lasting 6‐8 weeks). Most available form of exercise was walking, but other forms of aerobic exercise were acceptable. HR < 130 bpm or resting HR plus 30 bpm, or RPE 11‐15. Participants exercised 2‐3 times per week, interval or continuous training for 15‐30 minutes. Phase III started from month 3 to 1 year. Target HR 60‐75% max HR, RPE 12‐16, 30‐45 minutes per session, no less than 3‐5 times per week. Components: exercise only. Setting: home‐ or centre‐based (community), participant choice Exercise programme modality: walking. Length of session: 15‐30 minutes, increasing to 30‐45 minutes. Frequency: 2‐3 sessions per week, increasing to 3‐5. Intensity: < 130 bpm or RPE 11‐13, increasing to 60‐75% max HR or RPE 12‐16. Resistance training included? No. Total duration: 12 months. Co‐interventions: None described Comparator: Usual care and conventional drug therapy post‐PCI Co‐interventions: none described. |
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| Outcomes | Mortality, MI hospitalisations | |
| Source of funding | Supported by Research Project for practice Development of National TCM Clinical Research Bases (JDZX2015133) | |
| Conflicts of interest | None declared | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information reported |
| Allocation concealment (selection bias) | Unclear risk | No information reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants reported missing for outcomes of interest, all participants completed the study |
| Selective reporting (reporting bias) | Unclear risk | No published protocol paper or trial registration, very little description in the methods section about outcome assessment |