Worcester 1993.
Methods |
Study design: parallel RCT Recruitment: patients admitted to CCU with AMI over 3 years Allocation: not reported Blinding: not reported/open‐management trial Randomisation: not reported Follow‐up(s): 4 and 12 months Description: intense versus light exercise in men < 70 years of age |
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Participants |
Baseline characteristics Intervention group (exercise training)
Intervention group (light exercise)
Included criteria
Excluded criteria
Baseline imbalances: ‐ Description and recruitment methods: during the 3 years of enrolment 339 men satisfied the criteria for entry to the study. Men < 70 years who had been admitted consecutively to a single CCU with AMI were eligible for the study. Physically demanding work (i.e. white‐ vs blue‐collar): blue‐collar Severity of CHD: severe (included clinical heart failure) |
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Interventions |
Intervention characteristics
Control group
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Outcomes | Proportion at work at < 6 months (short term): 4 months Proportion at work at 6 –12 months (medium term): 12 months Spielberger state anxiety trait inventory; IPAT depression scale; Hackett‐Cassern denial scale; Eysenck personality inventory Adverse events (mortality) |
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Identification |
Sponsorship source: National Heart Foundation of Australia Country: Australia Setting: Australian teaching hospital: single centre, at the Austin Hospital, Melbourne; outpatient Possible conflicts of interest: not reported Ethics committee approval: all participants gave their informed consent. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation method is not explicitly described. However, the study authors cite a paper by Peto et al (1976) that describes randomisation techniques and includes a random numbers table |
Allocation concealment (selection bias) | Unclear risk | No allocation concealment is described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the study, blinding of participants (and personnel) is not possible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors is described, and the assessment of occupational status seems to have been accomplished with semi‐structured interviews and not with a validated questionnaire or an independent external source, such as employment records. However, several validated instruments measuring depression and anxiety were used to assess quality of life. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The loss to follow‐up was greater in the Intervention group at both the 4‐ and 12‐month reviews. No ITT analysis was conducted. |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol was available |
Other bias | Unclear risk | None identified |
AMI: acute myocardial infarction; APQLQ: Angina Pectoris Quality of Life Questionnaire; BMI: body mass index; BP: blood pressure; CABG: coronary artery bypass grafting CABS: coronary artery bypass surgery; CAD: coronary artery disease; CCU: coronary care unit; CHD: coronary heart disease; CPK: creatine phosphokinase; CPK‐MB: creatine kinase‐muscle/brain; ECG: electrocardiogram; ERNA: Early Return to Normal Activities; GP: general practitioner; HRQoL: health‐related quality of life; IPAT: Institute for Personality and Ability Testing; ITT: intention‐to‐treat; IQR: interquartile range; LDH: lactate dehydrogenase; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NYHA: New York Heart Association; PCI: percutaneous coronary intervention; PTCA: percutaneous transluminal coronary angioplasty; QoL: quality of life; RCT: randomised controlled trial; RTW: return to work; SF‐36: 36‐item short form survey; S‐ASAT: serum aspartate aminotransferase; SGOT: serum glutamic oxaloacetic transaminase; W: Watts; WHO: World Health Organization; YMCA: Young Men's Christian Association