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

Oldridge 1991.

Methods Study design: parallel RCT
Recruitment: all patients admitted with a diagnosis of AMI to any 1 of 6 local hospitals
Allocation: not reported
Blinding: investigators were not blinded to allocation; blinding of participants it is not described
Randomisation: not described
Follow‐up(s): 2, 4, 8 and 12 months
Description: combined outpatient rehabilitation programme
Participants Baseline characteristics
Intervention group
  • Mean age (SD): 52.9 (9.5)

  • Sex (male %): 78.9

  • Number of participants randomised: 99

  • Working before CHD: 65


Control group
  • Mean age (SD): 52.7 (9.5)

  • Sex (male %): 88.2

  • Number of participants randomised: 102

  • Working before CHD: 74


Inclusion criteria AMI patient
Exclusion criteria
  • Residence > 30 miles from the Health Sciences Centre

  • Inability to exercise due to uncontrolled dysrhythmias, heart failure or unstable angina

  • Neurologic, orthopaedic, peripheral vascular or respiratory disease

  • Inability to complete the QoL questionnaires due to cognitive or language problems

  • Depression levels: patients scoring < 5 on the short form of the Beck Depression Inventory or < 43 on the Spielberger State Anxiety Inventory or < 42 on the Spielberger Trait Anxiety Inventory 17 while still in hospital were not considered eligible for the study


Baseline imbalances:
Physically demanding work: unknown
Severity of CHD: less severe
Interventions Intervention characteristics
  • Cognitive behavioural group intervention

    • Once weekly counselling session (to enhance a participant’s confidence in resuming customary activities)

    • For spouse as well (learning to manage own anxiety in response to the participant’s heart attack and to support the participant)

    • Counselling objective was to, "provide patients an opportunity to identify, evaluate and manage their own feelings, attitudes, thoughts and behavioural responses to the physical changes, treatment regimens and health behaviour expectations associated with recovering".

  • Course in cardiopulmonary resuscitation for the spouse

  • Exercise conditioning:

    • 8 x 90 min (10‐min group warm‐up, stationary cycle ergometry, treadmill walking and arm ergometry for 20‐30 min, cool‐down involving low‐intensity activities; initially on 65% of the maximal heart rate)

    • Complemented by progressive relaxation training ("to reinforce the perception of self‐control and self‐competence, and to help manage episodes of apprehension if they occurred")

  • Duration of intervention: 8 weeks

  • Providers: group leaders without formal training in counselling, cardiologist, qualified exercise specialist


Control group
  • Conventional community care

Outcomes Proportion at work at 6–12 months (medium term): 12 months
QoL after AMI questionnaire (self‐developed), quality of well‐being questionnaire
Adverse events (mortality)
Identification Sponsorship source: Grant 6606‐2724‐44 from the National Health Research and Development Programme, Health and Welfare, Canada
Country: USA
Setting: single‐centre: the Health Sciences Centre; the intervention sessions were held in a hospital gymnasium; outpatient
Possible conflicts of interest: no information provided
Ethics committee approval: ethics committees of the University and each hospital
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk It is not clear how the allocation sequence was generated.
Allocation concealment (selection bias) Unclear risk The study authors report that participants received the next available study number with the associated group allocation. It is unclear if this method is sufficient to prevent bias.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Due to the nature of the intervention (supervised exercise, cognitive behavioral intervention), blinding of participants would not have been possible.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Another possible limitation to the present study is that the investigators were not blinded to allocation, although such bias would be expected to favour the rehabilitation group."
Quote: "Mortality and work status were monitored throughout the study." ‐ unclear how this was done
Incomplete outcome data (attrition bias) 
 All outcomes Low risk A low number of study participants were lost to follow‐up. The number of study participants who died during the follow‐up period was also similar in both study arms (intervention n = 3, control group n = 4).
Selective reporting (reporting bias) Unclear risk Unable to determine, no study protocol was available
Other bias Unclear risk None identified