Rivas 1988.
Methods |
Study design: 3‐arm RCT Recruitment: first AMI patients admitted to CCU Allocation: not reported Blinding: not reported Randomisation: no method described Follow‐up(s): 3 months, 6 months, 9 months, 12 months Description: combined outpatient rehabilitation including supervised training with psychological and vocational counselling with more (group A) and less (group B) intense physical training |
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Participants |
Baseline characteristics Intervention group (rehabilitation group A)
Interventions group (rehabilitation group B)
Control group
Inclusion criteria
Exclusion criteria: none Baseline imbalances: ‐ Physically demanding work: white‐collar Severity of CHD: unclear |
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Interventions |
Intervention characteristics
Control group
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Outcomes | Proportion at work at < 6 months (short term): 3 months Proportion at work at 6–12 months (medium term): 12 months Adverse events (mortality) |
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Identification |
Sponsorship source: Institute of Cardiology and Cardiovascular Surgery, Rehabilitation Center Country: Cuba Setting: single centre (Institute of Cardiology and Cardiovascular Surgery, Rehabilitation Center), ambulant Possible conflicts of interest: no information provided Ethics committee approval: not reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...patients were randomly distributed according to a table of random numbers in three groups" |
Allocation concealment (selection bias) | Unclear risk | No method of allocation concealment is described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the intervention (outpatient exercise programmes), blinding of participants and personnel would not have been possible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding of outcome assessors, nor is the method of assessing RTW is mentioned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | For intervention group A and the control group, the number of study participants reported to be lost to follow‐up due to death was the same (n = 1). Together in groups A and B a total of 3 study participants were lost due to retirement compared to 5 study participants in the control group. |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol was available |
Other bias | Unclear risk | None identified |