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. 2019 Mar 14;2019(3):CD010748. doi: 10.1002/14651858.CD010748.pub2

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
Participants Baseline characteristics
Intervention group (exercise training)
  • Mean age (SD): 54.8(0.8)

  • Sex (male %): 100

  • Number of participants randomised: 108

  • Working before CHD: 81


Intervention group (light exercise)
  • Mean age (SD): 53.9(0.8)

  • Sex (male %): 100

  • Number of participants randomised: 116

  • Working before CHD: 84


Included criteria
  • Men

  • < 70 years

  • Admitted consecutively to a single CCU with transmural (Q‐wave) AMI


Excluded criteria
  • Distance from programme venues

  • Inadequate command of the language

  • Anticipated non‐compliance with the programme

  • Psychological disability

  • Contamination, based on expressed preference for one or the other programme

  • Early transfer to another hospital

  • Excluded due to an administrative error


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)
Interventions Intervention characteristics
  • Exercise training

    • 3 x 1 h classes/week in a gymnasium owned by the YMCA

    • Training programme complied with American Heart Association recommendations

    • Duration of intervention: 8 weeks

    • Providers: teacher of physical education; physician attending


Control group
  • Light exercise 2 x 1 h classes/week in the outpatient physiotherapy room (8 )

  • Duration of intervention: 8 weeks

  • Providers: physiotherapist

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)
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.
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