Sandström 2005.
Methods |
Study design: Single centre RCT Country: Sweden Dates patients recruited: NR (recruited over a period of 2½ years) Maximum follow up: 12 months |
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Participants |
Inclusion criteria: Patients > 65 years admitted following an acute coronary event. Patients had to perform a pre‐discharge exercise test with a workload of ≥ 70 watts in men and ≥ 50 watts in women. Exclusion criteria: Patients with neurological sequels, memory dysfunction such as dementia, orthopaedic disability, inability to speak or understand Swedish, or both, and a planned coronary intervention within 3 months. N Randomised: total: 101; intervention: 50; comparator: 51 Diagnosis (% of pts): Angina pectoris: intervention: 20%; comparator: 21% Previous AMI: intervention: 18%; comparator: 11% Acute coronary event: intervention: 50%; comparator: 51% Previous PCI: intervention: 7%; comparator: 5% Previous CABG: intervention: 9%; comparator: 9% (Not mutually exclusive numbers.) Age (median): total: 71 years (range 64‐84); intervention: 71 years (range 64‐84); comparator: 71 years (range 65‐83) Percentage male: total 80.2%; intervention: 82%; comparator: 78.4% Ethnicity: NR |
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Interventions |
Intervention: 50 min aerobic group training programme three times a week for 3 months, with a voluntary 50 min step‐down period once a week for another 3 months. The complete programme was supported by music, which guided the intensity of the performance during the session. The training sessions were followed by 10 min of relaxation, also supported by music. Components: exercise only. Setting: centre‐based supervised group sessions. Aerobic exercise: Modality: aerobic exercises to music. Length of session: 50 min with a voluntary 50 min step‐down period once a week for another 3 months. Frequency: 3 times a week. Intensity: NR Resistance training included? No. Total duration: 3 months. Co‐interventions: none described. Comparator: patients were recommended to take a daily walk at a comfortable speed, and to gradually increase the time, length and speed, and were encouraged to restart their prior physical activity as soon as they felt fit enough for this. Co‐interventions: none described. |
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Outcomes | HRQL and revascularisation | |
Source of funding | NR | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "….were randomly allocated into one of two groups:” |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not described. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “patients were evaluated ….. by an independent, blinded to group allocation, researcher.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no attrition ‐ data was reported for all patients randomised. |
Selective reporting (reporting bias) | Low risk | All outcomes mentioned in methods were reported at all time points. |
Groups balanced at baseline | Low risk | “There were neither demographic nor medical differences between the two groups at baseline.” |
Intention‐to‐treat analysis conducted | Low risk | ITT was not described, but results are reported for same number of patients randomised to each group. |
Groups received same treatment (apart from the intervention) | Low risk | All patients received verbal and written information about the importance of regular physical activity after an acute coronary event. They were recommended to take a daily walk at a comfortable speed, and to gradually increase the time, length and speed. |