Stern 1983.

Methods	Study design: 3‐armed RCT Recruitment: 3‐year recruitment period. Recruited from the CCU, internists, and the larger community. MI documented within 6 weeks‐1 year prior to study admission Allocation: not reported Blinding: not reported Randomisation: block randomisation; no method described Follow‐up(s): 3, 6, and 12 months Description: intervention included either supervised exercise or group counselling
Participants	Baseline characteristics Study participants were predominantly white, married, middle to upper‐middle class men admitted to the study 7 months (mean) after MI Intervention group (counselling) Mean age (SD): ‐ Sex (male %): 88.5 Number of participants randomised: 35 Working before CHD: 26 intervention group (exercise therapy) Mean age (SD): ‐ Sex (male %): 90.5 Number of participants randomised: 42 Working before CHD: 31 Control group (CG) Mean age (SD): ‐ Sex (male %): 75.9 Number of participants randomised: 29 Working before CHD: 24 Inclusion criteria Work capacity level of < 7 Metabolic Equivalents (MET) (men) or < 6 MET (women) when exercised on a treadmill to 85% of the predicted age Adjusted maximum or to the appearance of symptoms or other abnormal responses that could terminate the exercise prior to the heart rate end point And/or a Taylor Manifest Anxiety Scale1 raw score of 19+‐ and/or Zung Self‐rating Depression Scale 2 raw score of 40+ Exclusion criteria Unstable cardiovascular condition present (i.e. congestive heart failure, or required treatment for any physical/psychologic reason) Baseline imbalances: Not married: counselling: 14% (n = 5); exercise: 12% (n = 5); control group: 45% (n = 13) 49‐58 years: counselling: 34% (n = 12) ; exercise: 67% (n = 28); control group: 34% (n = 10) Admitted < 4 months after MI: counselling: 43% (n = 15); exercise: 21% (n = 9); control group: 21% (n = 6) Physically demanding work: unknown Severity of CHD: less severe
Interventions	Intervention characteristics Exercise therapy 3 × 1‐h sessions/week over a 12‐week period for a total of 36 sessions All exercises were dynamic, involving rhythmic movements against resistance; half were upper limb (rowing machine, arm wheel, and arm ergometer) and half were lower limb (treadmill, cycle, and step ergometer) Participants exercised upper and lower limbs alternately for 4 min with 2 min of rest in between Exercise intensity was determined by heart‐rate response, with the target level being 85% of the peak exercise heart rate achieved in the first evaluation. If the heart rate was consistently above or below target, the work load was increased or decreased Close supervision and continuous ECG monitoring of exercise allowed for rapid detection of any abnormalities in rhythm or ST segments Duration of intervention: 12 weeks Providers: sessions were supervised by a physical educator and a physician’s assistant trained in emergency cardiac care, with a cardiologist either present or immediately available Group counselling participants attended 12 × 60‐75‐min weekly group counselling sessions. 1st session: acquaint participants with general problems encountered during convalescence 2nd and 3rd sessions: educational (the anatomy, common MI complications, cardiac procedures; risk factors ‐ ranging from family history to hypertension, obesity, smoking, and stress) 4th session: stress, especially self‐induced by type A behaviour, members providing examples and leaders provided guidelines for reducing time urgency and hostility. Participants were also taught the Jacobsen relaxation exercises and encouraged to do these at least twice daily. 5th‐11th sessions: general areas of stress (at work, at home, socially, sexually, physically, or in relation to the need to diet, give up smoking, and increase levels of physical activity) 12th final session: summary discussion and general critique of the group. Duration of intervention: 12 weeks Providers: psychiatrist/social worker and nurse clinician Control group Participants in the control group received no specific assignment. Instead, they were followed up by their physicians and given routine post‐MI medical care. They were requested to not join a supervised exercise or a formal counselling programme.
Outcomes	Proportion at work at 6–12 months (medium term): 12 months Taylor Manifest anxiety, Zung Depression Adverse events (mortality, MI, bypass)
Identification	Sponsorship source: grant G008003044 from the National Institute of Handicapped Research, Department of Education, Washington DC Country: USA Setting: George Washington University Hospital; single‐centre; outpatient Possible conflicts of interest: no information provided Ethics committee approval: not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Participants were randomised into 3 study groups in blocks of 6, but the method of sequence generation is not described.
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 interventions examined (supervised exercise training or group counselling), the blinding of study participants and personnel would not have been possible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No blinding of outcome assessors is mentioned and it is unclear if a validated questionnaire was used to assess RTW at the follow‐up.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	It seems as if no participants were lost to follow‐up for the evaluation of RTW. However, it is unclear if non‐compliant study participants in the intervention groups were excluded from some or all of the outcome assessments.
Selective reporting (reporting bias)	Unclear risk	Unable to determine, no study protocol was available
Other bias	Unclear risk	None identified