Oldridge 1991.
Methods |
Study design: Multicentre RCT (6 sites) Country: Canada Dates patients recruited: NR Maximum follow up: 1 year |
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Participants |
Inclusion criteria: Diagnosis of AMI and 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 while still in hospital. Exclusion criteria: Residence > 30 miles from the Health Sciences Centre; inability to exercise due to uncontrolled dysrhythmias, heart failure or unstable angina; neurologic, orthopedic, peripheral vascular or respiratory disease; and inability to complete the quality of life questionnaires due to cognitive or language problems. N Randomised: total: 201; intervention: 99; comparator: 102 Diagnosis (% of pts): MI: 100% Age (mean ± SD): intervention: 52.9 ± 9.5; comparator: 52.7 ± 9.5 Percentage male: intervention: 88%; comparator: 90% Ethnicity: NR |
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Interventions |
Intervention: Participants attended 50 min exercise sessions twice a week for 8 consecutive weeks. These sessions were held in a hospital gymnasium under the direct supervision of a cardiologist and qualified exercise specialists. There was a I0 min group warm‐up at the beginning of each session; stationary cycle ergometry, treadmill walking and arm ergometry followed for 20 to 30 minutes. A cool‐down, involving low‐intensity activities, concluded the exercise session. Components: exercise and behavioural counselling. Setting: centre. Aerobic exercise: Modality: stationary cycle ergometry, treadmill walking and arm ergometry. Length of session: 50 min. Frequency: twice a week. Intensity: initially on 65% of the maximal heart rate. Resistance training included? No. Total duration: 8 weeks. Co‐interventions: The cognitive behavioural group intervention, facilitated by group leaders without formal training in counselling, consisted of 8 sessions of 90 minutes complemented by progressive relaxation training at the end of the session. Both patient and spouse were invited to attend the group sessions. Comparator: conventional care. Co‐interventions: none described. |
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Outcomes | Mortality Health‐related quality of life: QOLMI time trade‐off. Cost data reported in Oldridge 1993 | |
Source of funding | This work was supported by the National Health Research and Development Programme, Health and Welfare, Canada | |
Conflicts of interest | NR | |
Notes | Both groups improved over 12 months, with the biggest changes occurring in the first 8 weeks. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized" |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "the investigators were not blinded to allocation" |
Incomplete outcome data (attrition bias) All outcomes | High risk | For the primary outcome ‐HRQL‐ 9% lost to follow up, no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported at all time points. |
Groups balanced at baseline | Low risk | “Randomization was successful, in that patients allocated to rehabilitation and conventional care groups were essentially comparable.” |
Intention‐to‐treat analysis conducted | High risk | No. |
Groups received same treatment (apart from the intervention) | High risk | “Eligible patients were ..... randomized to either community care (control) or an experimental (treatment) group in which small groups of patients received an exercise prescription and behavioural counselling.” |