Froelicher 1994.

Methods	Study design: 3‐armed RCT Recruitment: patients admitted to CCUs of 7 hospitals, September 1977‐December1979 Allocation: not reported Blinding: not reported Randomisation: not reported Follow‐up(s): 6 months Description: a 3‐arm RCT with exercise or exercise with education counselling, relaxation therapy, and family support provided
Participants	Baseline characteristics Intervention group 1 – exercise Mean age (SD): 55.6 (9.3) Sex (male %): 88 Number of participants randomised: 88 Working before CHD: 69 Intervention group 2 – exercise and teaching counselling Mean age (SD): 56.3 (8.3) Sex (male %): 84 Number of participants randomised: 86 Working before CHD: 58 Control group Mean age (SD): 57.1 (7.3) Sex (male %): 88 Number of participants randomised: 84 Working before CHD: 59 Inclusion criteria A primary diagnosis of confirmed AMI Free of complications for ≥ 24 h within 7 d of hospital admission Able to walk without aid Able to speak and read English Free from serious non‐cardiac complications before the admission Resided within a 50 mile radius from the University of Washington Exclusion criteria > 71 years of age Prolonged complications Physical limitations Non‐cardiac diseases Other cardiac diseases Baseline imbalances: ‐ Description and recruitment methods: all consecutively admitted patients ≤ 70 years of age diagnosed AMI admitted to CCUs of 7 participating Seattle hospitals during 1977 through 1979 were screened for inclusion in the study. Physically demanding work (i.e. white vs. blue collar): unknown Severity of CHD: severe (patients with angina included)
Interventions	Intervention characteristics Intervention 1 – exercise Participants participated in an inpatient exercise programme Exercise prescribed based on treadmill‐tests given before discharge After discharge, participants had weekly 30 min outpatient appointments with a research nurse to review the prior week’s activities and responses to daily activities carried out at home Duration of intervention: 3 months Providers: intervention 1 – B 1 The research staff (research nurse/ occupational therapist) were instructed to offer advice, but not formal teaching. Intervention 2 – exercise and counselling In addition to exercise (described above): A series of 12 times 1‐h group education‐counselling sessions Relaxation therapy for 20‐40 min of content with liberal time for Q&A, discussion, and problem solving Spouses and friends were encouraged to attend the sessions to assist with the problem solving and provide family support Duration of intervention: 3 months Providers: intervention 2 – B research staff (research nurse/occupational therapist), educational classes by two research staff cardiovascular clinical nurse specialists and a physical therapist specially trained in methods of relaxation therapy Control group Usual care
Outcomes	Proportion at work at < 6 months (short term): 5.5 months (24 weeks) Sickness impact profile Adverse events (mortality, cardiac surgery)
Identification	Sponsorship source: study was supported by Research Grant 5 ROI NU 00589‐04 from the Bureau of Health Professions, Division of Nursing, Department of Health and Human sciences Country: USA Setting: multicentre: seven North‐Western hospitals; in‐ and outpatient Possible conflicts of interest: not reported Ethics committee approval: the participants gave an informed consent to participate in the study. "Human subjects review committee requirements for human informed consent were observed."
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The randomisation method is not clearly stated. Quote: "Randomization was designed to provide patients in each hospital with an equal chance to be assigned to one of three groups..."
Allocation concealment (selection bias)	Unclear risk	No allocation method is reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the study, blinding of participants and personnel was not possible.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Although no blinding of outcome assessors is reported, a validated standardised questionnaire (Activity Summary Questionnaire) was used at regular intervals to determine if participants had returned to work.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Attrition due to withdrawal and the medical reasons for withdrawal reported (i.e. surgery, death) were similar across all three groups. However, "of the remaining 207 patients eligible for follow ‐up, 177 (86%) had completed questions pertaining to return to work, defined as return to the same job as before AMI." 14% of the participants eligible for follow‐up had not completed questions pertaining to RTW
Selective reporting (reporting bias)	Unclear risk	Unable to determine, no study protocol was available.
Other bias	Unclear risk	None identified