Leizorovicz 1991.
Methods |
Study design: Multicentre RCT (4 sites) Country: France Dates patients recruited: February 1981 to May 1984 Maximum follow up: 2 years |
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Participants |
Inclusion criteria: Admitted to participating coronary care units with suspected MI; < 65 years old with typical MI, no major irreversible complication or disability. Exclusion criteria: Contraindication to exercise testing i.e., recent stroke, disability of lower limbs, uncontrolled heart failure, severe rhythm disturbances, SBP > 180 mmHg, severe angina pectoris, or abnormalities triggered by baseline exercise test. N Randomised: total: 182; intervention: 61; comparator (usual care): 60 counselling programme: 61 (no data analysed in this review) Diagnosis (% of pts): MI: 100% Age (mean): intervention: 51; comparator: 49 Percentage male: 100% Ethnicity: NR |
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Interventions |
Intervention: The programme started within a few days of randomisation and included three training sessions a week on a cycloergometer, walking and gymnastics. Components: Exercise and education. Setting: Centre. Aerobic exercise: Modality: cycloergometer, walking and gymnastics. Length of session: 25 min. Frequency: 3 times per week. Intensity: 80% of max HR and then decreased progressively over 2 min (increased as the sessions progressed). Resistance training included? No. Total duration: 6 weeks. Co‐interventions: Also included respiratory physiotherapy, relaxation, recommendations on control of cardiovascular risk factors (smoking habits, diet); recommendations to continue regular physical training at the end of the 6‐week programme. Comparator: Patients in the usual care group were referred to their usual private practioner or cardiologist or both. Co‐interventions: None described. |
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Outcomes | Non fatal MI, angina, surgery. | |
Source of funding | Institut National de la Same et de la Recherche Medicale, by the Hospices Civils de Lyon and by the Association pour la Promotion et la Realisation d'Essais Therapeutiques. | |
Conflicts of interest | NR | |
Notes | Only 14% of all MI patients admitted to the participating hospitals were randomised to the trial. Exclusion of women and patients > 65 accounted for 60% of exclusions. | |
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 | No losses to follow up. |
Selective reporting (reporting bias) | Low risk | All outcomes reported for all time points (although absolute values not always given). |
Groups balanced at baseline | Low risk | "Baseline characteristics were identical in the three groups". |
Intention‐to‐treat analysis conducted | Low risk | Yes. |
Groups received same treatment (apart from the intervention) | High risk | “The rehabilitation programme …. included: three training sessions a week on a cycloergometer; walking; gymnastic and respiratory physiotherapy; relaxation; recommendations on control of cardiovascular risk factors (smoking habits, diet); recommendations to continue regular physical training at the end of the 6‐week programme.” “Patients randomized to CP attended a group session with a cardiologist, a psychiatrist, a nutritionist and a physiotherapist whenever possible......Patients in the UC group were just referred to their usual private practioner and/or cardiologist.” |