Carlsson 1998.
Methods |
Study design: Single centre RCT Country: Sweden Dates patients recruited: NR Maximum follow up: 1 year |
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Participants |
Inclusion criteria: AMI; CABG < 2 weeks prior; PCI < 2 weeks prior. Exclusion criteria: Signs of unstable angina; signs of ST‐depression at exercise test of more than 3 mm in 2 chest leads or more than 2 mm in two limb leads at four weeks post‐discharge from hospital, signs of CHF, severe, non‐cardiac disease; drinking problems, not a Swedish speaker. N Randomised: total: 235; intervention: 118; comparator: 117 Diagnosis (% of pts): CABG: 29% AMI: 21% Age (mean ±SD): AMI patients: intervention: 62.2 ± 5.8; comparator: 61.7 ± 6 CABG patients: intervention: 62.7 ± 4.8; comparator: 59.8 ± 4.8 Percentage male: NR Ethnicity: NR |
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Interventions |
Intervention: Continuous physical exercise programme 2–3 times weekly for a period of 2–3 months. The exercise sessions lasted one hour and were comprised of the following parts: 10 minutes of warm‐up; 40 minutes of interval walking or jogging; 10 minute cool down period (consisting of relaxation and light stretching exercises). Individual exercise schedules were provided in order to maintain the effects of the exercise programme beyond the discharge from the hospital training centre. Components: exercise plus education. Setting: centre and then home. Aerobic exercise: Modality: walking or jogging. Length of session: 60 minutes. Frequency: 2‐3 times/week. Intensity: NR Resistance training included? no. Total duration: 2‐3 months. Co‐interventions: 9 hours of nurse counselling in individual and group sessions over 1 year; smoking cessation 1.5 hours, dietary management 5.5 hours. Comparator: Usual Care, which included two or three visits to their general practitioners during the first year. Co‐interventions: All patients were informed about CAD risk factors and the effect of lifestyle changes on the prognosis. |
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Outcomes | Mortality. | |
Source of funding | NR | |
Conflicts of interest | NR | |
Notes | Groups of 20 patients randomly allocated to intervention and control groups (usual care). Randomised 4 weeks post discharge. In first 3 weeks post discharge all participants had 2 visits by nurse & 1 by cardiologist + all participants invited to join regular exercise group x 1 per week for 30 mins information & 30 mins easy interval training. | |
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 | High risk | < 20% lost to follow up, no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | Low risk | All outcomes reported at all time points. |
Groups balanced at baseline | Unclear risk | Basline data not shown. |
Intention‐to‐treat analysis conducted | Low risk | Yes. |
Groups received same treatment (apart from the intervention) | High risk | "The intervention consisted of nurse counselling, dietary education and physical training.…….During the time from randomisation, three weeks after discharge from hospital to three months later, the patients in the intervention group participated in an education programme.” |