Hofman‐Bang 1999.
Methods |
Study design: Single centre RCT Country: Sweden Dates patients recruited: February 1993 to December 1995 Maximum follow up: 2 years |
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Participants |
Inclusion criteria: (a) at least one significant stenosis suitable for PTCA and at least one additional—although clinically nonsignificant—stenosis or plaque, measurable with quantitative computerised angiography (QCA); (b) age < 65 years; (c) employed; (d) absence of other diseases of importance for the programme or with poor prognosis; and (e) able to perform a bicycle ergometer test with a minimum exercise capacity of 70 watts. Exclusion criteria: None described N Randomised: total: 87; intervention: 46; comparator: 41 Diagnosis (% of pts): treated with percutaneous transluminal angioplasty. Age (mean): intervention: 53; comparator: 53 Percentage male: 83.9% Ethnicity: NR |
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Interventions |
Intervention: Started with a 4‐week residential stay at the intervention unit. The programme included intense health education and activities promoting behavioural changes ‐ stress management, diet, exercise and smoking habits. Each subject was assigned a daily individual task including self‐observation, Type A behavioural drills, relaxation training and exercise. Followed by 11‐month structured maintenance programme. Components: Exercise plus psychological plus education. Setting: Centre followed by home. Aerobic exercise: NR Modality: NR Length of session: NR Frequency: NR Intensity: NR Resistance training included? NR Total duration: 12 months. Co‐interventions: Maintenance programme consisted of continuous self‐observation and self‐recording of important everyday lifestyle behaviours, feedback of behaviour changes, and of regular follow‐up contacts between the patient and his/her personal coach for verbal feedback, problem‐solving, and replanning discussions when needed. Comparator: standard care. Co‐interventions: none described. |
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Outcomes | Cardiovascular mortality, MI, CABG, PTCA, hospitalisations, health‐related quality of life: Angina Pectoris Quality of Life Questionnaire (APQLQ) recorded during the 2 years follow up. | |
Source of funding | AMF Insurance Co., the SPP Insurance Co., and The Swedish Heart and Lung Foundation. | |
Conflicts of interest | NR | |
Notes | 93 patients were randomly assigned to an intervention group or a control group, respectively. Six subjects (two in the intervention group and four in the control group) refused further participation in close connection to randomisation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned" |
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 | 21.8 % lost to follow up, no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | Low risk | All outcomes reported at all time points. |
Groups balanced at baseline | High risk | Significant difference between groups in use of beta blockers. |
Intention‐to‐treat analysis conducted | High risk | No. |
Groups received same treatment (apart from the intervention) | High risk | "Subjects in the intervention group participated in a comprehensive behaviorally oriented program aimed at achieving significant long‐term changes in risk factor–related lifestyle behavior….included health education and behavior‐change activities, including lectures and discussions, habit rehearsal directed toward stress management and diet, exercise, and smoking habits. …..” |