Fridlund 1991.
Methods |
Study design: Single centre RCT Country: Sweden Dates patients 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 pts): 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: Patients 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. Aerobic exercise: 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). |
Groups balanced at baseline | Low risk | “All differences are non‐significant according to the chi‐square test and /or ANOVA test”. |
Intention‐to‐treat analysis conducted | Low risk | Yes. |
Groups received same treatment (apart from the intervention) | High risk | "The rehabilitation programme involved two intervention strategies as its main objective (a) lifestyle and life stress orientated and (b) social support oriented…..group sessions consisted of a physical and a psychosocial part and were carried out together with a support team…” |