Ma 2020.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: China Dates participants recruited: January 2014 to December 2015 Maximum follow‐up: 36 months (12 month intervention plus 24 month follow‐up) |
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Participants |
Inclusion criteria: angiographically diagnosed as unprotected left main coronary artery disease (ULMCAD), and the ‘unprotected’ in this context was defined that no perfusion distal to the left main stenosis was supplied by either a patent bypass graft or a collateral vessel; underwent CABG for the first time; age ≥ 18 years; able to independently fulfil the assessment questionnaires used in the study; likely to be followed up regularly, which was evaluated by the investigators. Exclusion criteria: cardiogenic shock; cerebrovascular accident with a persistent neurological deficit before enrolment; complicated with malignancies; pregnant or lactating women. N randomised: total: 300; intervention: 150; comparator: 150. Diagnosis (% of participants): CABG (100%). Age (mean, SD): intervention: 63.1 ± 9.7; comparator: 62.8 ± 10.7. Percentage male: intervention: 121 (80.7%); comparator: 115 (76.7%). Ethnicity (white, %): NR |
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Interventions |
Intervention: Comprehensive rehabilitation and intensive education (CRIE) program consisting of 4 components: 1. CAD‐related health education (1/wk for 2 months) – lectures covering basic knowledge of disease, primary therapeutic strategies, risk factors, antiplatelet and anticoagulant therapy, BP management, lipid, glucose, and uric acid, prevention of upper GI mucosal injury, rehabilitation management about exercise, diet and nutrition, psychological care and good lifestyle formation. 2. Exercise guidance and formation (1/month for 10 months) – formulating an individualised exercise plan covering exercise mode: low intensity walking, moderate intensity aerobics (e.g. jogging, gymnastics, tai chi, bicycling), and moderate to high resistance training (e.g. mountain climbing, mid‐distance sprint); duration 60 to 90 mins each time; frequency 3 to 5 times per week; intensity: RPE 11 to 13. Monthly supervision and guidance by motivational interviewing. 3. Risk factor control (1/month for 10 months): diet control, alcohol and cigarette cessation, management of blood pressure, lipid, glucose and uric acid. Monthly supervision and guidance by motivational interviewing. 4. Psychological nursing (1/month for 10 months): making a holistic assessment of each participants' physical, functional, psychological, social and spiritual status; identifying potential issues in psychological aspects; eliminating negative emotions and improving compliance; providing music therapy. Components: exercise plus education and psychological nursing Setting: centre‐based lectures, with home‐based exercise Exercise programme modality: low‐intensity walking, moderate‐intensity aerobics Length of session: 60 to 90 minutes Frequency: 3 to 5 sessions per week Intensity: RPE 11 to 13 Resistance training included? Yes: moderate‐high intensity resistance training described as mountain climbing or mid‐distance sprinting Total duration: 12 months Co‐interventions: none described Comparator: participants provided discharging guidance and a CAD‐related health education manual (same as distributed to intervention group). Provided rehabilitation recommendations and medication consultation through telephone calls or clinic visits according to need. Co‐interventions: None described |
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Outcomes | Major adverse cardiac and cerebrovascular events (composite outcome), HRQoL | |
Source of funding | Supported by National Clinical Key Speciality Construction Project | |
Conflicts of interest | None declared | |
Notes | We contacted authors, requesting specific clinical outcome data, but received no response. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomisation sequence was computer‐generated using SAS 9.1" |
Allocation concealment (selection bias) | Low risk | "The assignment of patients was performed by an independent nurse with the use of sealed envelopes" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided regarding blinding of outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number of participants lost to follow‐up provided ( < 20%) and appear balanced across groups, but no reasons provided |
Selective reporting (reporting bias) | Unclear risk | No published protocol paper or trial registration |