Fridlund 1991.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: Sweden Dates participants recruited: September 1985 to March 1988 Maximum follow‐up: 5 years |
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Participants |
Inclusion criteria: 65 years or younger at the time of MI; independent living in the Health Care District after discharge from hospital; meaningful communication and rehabilitation that was not hindered by the MI or other serious illness Exclusion criteria: cerebral or cardiac disorders or serious alcohol abuse N randomised: total: 178; intervention: 87; comparator: 91 Diagnosis (% of participants): MI: 100% Angina: intervention: 32.1%; comparator: 33.3% Age (years): intervention: 55; comparator: 57.6 Percentage male: 87% intervention: 86.8%; comparator: 87.3% Ethnicity: NR |
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Interventions |
Intervention: participants and their spouses visited the hospital for a 2‐hour group session each week for 6 months. These group sessions consisted of a physical and a psychosocial part and were carried out together with a support team consisting of a physiotherapist, a physician and a rehabilitation nurse. The physical part consisted of both exercise and relaxation. Components: exercise plus psychosocial support Setting: centre Exercise programme modality: NR Length of session: 2 hrs Frequency: once a week Intensity: NR Resistance training included? NR Total duration: 6 months Co‐interventions: the psychosocial part contained eleven themes concerning lifestyle and risks after MI, and psychosocial consequences of MI Comparator: routine cardiac follow‐up Co‐interventions: none described |
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Outcomes | Total mortality, non‐fatal MI, revascularisations | |
Source of funding | Swedish Heart Lung Foundation, National Association for Heart and Lung Patients, Sweden, and the County Council, Halland, Sweden | |
Conflicts of interest | NR | |
Notes | Positive long‐term effects on physical condition, life habits, cardiac health knowledge. No effects found for cardiac events or psychological condition. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly subdivided" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 32% lost to follow‐up; no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Low risk | All outcomes reported at all time points (although absolute values not always given). |