Van‐Dixhoorn 1999.
| Study characteristics | ||
| Methods |
Design: single‐centre RCT. Country: Netherlands. Dates participants recruited: 1981‐1983. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 5 years. Follow‐up schedule: post‐test (~ 6 weeks), 2 and 5 years. |
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| Participants |
Inclusion criteria: no age limit, diagnosis of recent MI (< 1 month), and the ability to participate in a physical exercise programme. Exclusion criteria: people considered in need of individual (psychosocial) help in addition to exercise training (from van Dixhoorn 1991). Indication (% participants): AMI within 1 month (100%). Psychopathology: none (0%). Age (mean ± SD): total: 55.5 (SD NR) years; intervention: 55.4 ± 8.2 years; comparator: 55.7 ± 8.1 years. Men: total: 94%; intervention: 93%; comparator: 95%. Ethnicity (% white): NR. |
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| Interventions |
INTERVENTION: procedure included: electromyography feedback of the frontalis muscle was used as a "mental device" to focus attention for passive relaxation, to give feedback of muscle tension and explain the concept of relaxation, and to monitor excess inspiratory effort. Participants also learned a method of breathing regulation and the therapist chose the appropriate instructions for each participant. Participants were asked to practise at home. Treatment targets: stress. Components: active and passive relaxation, homework. Treatment setting (number of sites): NR (NR). Modality (group size): individual. Dose:
Delivered by: 5 specially trained people including a psychologist, medical doctor, and physiotherapist. Follow‐up further reinforcement: NR. Cointerventions: physical exercise training (as provided to comparator group) and usual medical care. COMPARATOR: physical exercise training and usual medical care. Exercise training was offered as a 5‐week programme, once per day for 30 minutes, within groups of 4 participants supervised by 2 physiotherapists. Cointerventions: NR. |
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| Outcomes | Cardiac mortality. Non‐fatal MI. Revascularisation. Cost‐effectiveness. |
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| 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 | Reported randomisation, but insufficient detail provided. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Methods stated that clinical data were extracted from medical records, but did not state by whom. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All the randomised 156 participants were included in the 2‐ and 5‐year follow‐up analyses. |
| Selective reporting (reporting bias) | Unclear risk | Not described. |
| Groups balanced at baseline | Low risk | "There were no differences between the two treatments in base‐line clinical data as shown in Table 2." |
| Intention‐to‐treat analysis | Low risk | "Finally, dropouts were included and classified on the basis of the reason for not completing the programme." |
| Groups received same cointerventions | Low risk | Comparator participants received exercise training only, while intervention group participants received exercise training plus relaxation therapy. |
ACS: acute coronary syndrome; AMI: acute myocardial infarction; ANCOVA: analysis of covariance; BDI: Beck Depression Inventory (Beck 1997)|; CABG: coronary artery bypass graft; CAD: coronary artery disease; CBT: cognitive behavioural therapy; CHD: coronary heart disease; CVD: cardiovascular disease; DISH: Depression Interview and Structured Hamilton; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders ‐ 4th edition; ECG: electrocardiograph; HADS‐A: Hospital Anxiety and Depression scale ‐ Anxiety subscale (HADS 1983); HADS‐D: Hospital Anxiety and Depression scale ‐ Depression subscale (HADS 1983); HAM‐D: Hamilton Depression Rating Scale (HAM‐D 1988); HRQoL: health‐related quality of life; LVEF: left ventricular ejection volume; Maastricht Questionnaire: Maastricht Questionnaire for Vital Exhaustion (MIVE 1996; MQ 1987); MacNew Questionnaire: MacNew Heart Disease Heath‐Related Quality of Life Questionnaire (Lim 1993); MI: myocardial infarction; NR: not reported; NYHA: New York Heart Association; PCI: percutaneous coronary intervention; PHQ‐9: Patient Health Questionnaire 9; PSS‐10: Perceived Stress Scale 10; PTCA: percutaneous transluminal coronary angioplasty; RCT: randomised controlled trial; SADS‐C: Schedule of Affective Disorders and Schizophrenia ‐ Change; SCL‐90‐R: Symptoms Checklist List ‐ 90 ‐ Revised (SCL‐90‐R 1983); SD: standard deviation; SF‐12: 12‐item Short Form (Short Form Questionnaires); SF‐36: 36‐item Short Form (Short Form Questionnaires); SSM: supportive stress management; STAI: Spielberger Trait Anxiety Inventory (STAI 1970); STAXI: Spielberger Anger scales (STAXI 1985); STEMI: ST‐elevation myocardial infarction; ZDS: Zung Self‐rated Depression Rating Scale (Zung 1965).