Yu 2003.
Methods |
Study design: Single centre RCT Country: China Dates patients recruited: NR Maximum follow up: 2 years |
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Participants |
Inclusion criteria: Obese patients with CHD who had either recent AMI or had undergone elective PCI in last 6 wks. Exclusion criteria: Postinfarction angina without revascularisation procedures, significant valvular stenosis, active pericarditis or myocarditis, severe uncontrolled hypertension, physical problems that precluded exercise training, cognitive impairment, malignancies that limited life span to 1 year. N Randomised: total: 112; intervention: 72; comparator: 40 Diagnosis (% of pts): AMI: 64% PCI: 36% Age (mean ±SD): intervention: 62.3 ± 11.2; comparator: 61.2 ± 10.2 Percentage male: intervention: 82%; comparator: 75% Ethnicity: NR |
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Interventions |
Intervention: Phase 1 was an inpatient ambulatory programme that lasted 7 to 14 days. Phase 2 was a 16‐session, twice weekly, outpatient exercise and education programme lasting for 8 weeks. Each session included 1 hour of education class followed by 2 hours of exercise training. The first hour of training focused on aerobic CV training with a target intensity of 65% to 85% of maximal aerobic capacity. This included treadmill, ergometry, rowing, stepper, arm ergometry, and dumbbell and weight training.The next hour was conducted by an occupational therapist in which domiciliary or vocational environment‐focused training was performed. Phase 3 was a community‐based home exercise programme for another 6 months. Components: exercise and education. Setting: centre followed by home. Aerobic exercise: Modality: treadmill, ergometry, rowing, stepper, arm ergometry, and dumbbell. Length of session: 2 hours (for 8 weeks) then unspecified at home. Frequency: twice a week (for 8 weeks) then unspecified at home. Intensity: 65% to 85% of maximal aerobic capacity. Resistance training included? Weight training. Total duration: 8 1/2 months. Co‐interventions: Phase 4 was a long‐term follow‐up programme until the end of 2 years, which included half‐yearly monitoring of lipid profiles, and again stressed the importance of regular exercise and risk factor modification. Comparator: conventional medical therapy. Co‐interventions: The control group attended a 2‐hour talk that explained CHD, the importance of risk factor modification, and potential benefits of physical activity, but without undergoing an outpatient exercise training programme. |
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Outcomes | HRQL: 3F‐36 at 8 & 24 months. | |
Source of funding | NR | |
Conflicts of interest | NR | |
Notes | ||
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 of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients accounted for. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported at all time points. |
Groups balanced at baseline | Low risk | There was no difference in age, gender, disease demographics, and medications between the CRPP and control groups. |
Intention‐to‐treat analysis conducted | High risk | No. |
Groups received same treatment (apart from the intervention) | High risk | Cardiac rehabilitation and prevention program (CRPP) consists of exercise and education programme. |