Sivarajan 1982.
Study characteristics | ||
Methods |
Study design: Multicentre RCT (7 sites) Country: USA Dates participants recruited: 1 September 1977 to 2 December 1979 Maximum follow‐up: 6 months Random allocation of individuals to two intervention groups (exercise only (Intervention B1) or exercise plus teaching and counselling (Intervention B2)) and a control group (usual care). |
|
Participants |
Inclusion criteria: Previous MI, age < 70 years, living < 50 miles of centre. Exclusion criteria: prolonged complications, physical limitations, noncardiac or cardiac diseases, communication problems, other issues e.g. massive obesity, psychological problems, etc. N randomised: total: 258; Intervention B1: 88; Intervention B2: 86; comparator: 84 Diagnosis (% of participants): AMI: 100% Age (mean ±SD): Intervention B1: 55.6 ± 9.3; Intervention B2: 56.3 ± 8.3; comparator = 57.1 +/‐ 7.3 Percentage male: > 80% Ethnicity: > 80% white |
|
Interventions |
Intervention: The outpatient exercise programme was identical for the participants in groups Bl and B2. It consisted of a gradually progressive callisthenic and walking programme prescribed at weekly 30‐minute clinic visits and performed by the participant at home. Participants were instructed to exercise twice a day until they returned to work and once a day thereafter. If the participant was symptom free, the prescription was gradually increased to add callisthenics of increasing intensity and the distance and time (or rate) of walking were gradually advanced. Components: exercise only or exercise plus education and counselling. Setting: centre and home. Exercise programme modality: walking. Length of session: NR Frequency: twice a day until return to work and once a day thereafter. Intensity: NR Resistance training included? callisthenics. Total duration: NR Co‐interventions: participants in group B2, in addition to receiving exercise prescriptions as described above, attended a series of eight 1‐hour group sessions during weekly clinic visits. The sessions emphasised the practical aspects of anatomy and physiology of the heart, coronary artery disease, myocardial infarction and medications; risk factors, including smoking, hypercholesterolaemia, hypertension, stress and sedentary living; nutritional aspects of fats, cholesterol, salt and alcohol; activities and exercises; emotional reactions to myocardial infarction in participants and their families; resumption of sexual activity; and issues concerning return to work or, if retired, to an alternative, meaningful lifestyle. Comparator: conventional medical and nursing management throughout all phases of hospitalisation and convalescence at home. Co‐interventions: none described. |
|
Outcomes | Total mortality; health‐related quality of life: Sickness Impact Profile. | |
Source of funding | Bureau of Health Professions, Division of Nursing, Department of Health and Human Services. | |
Conflicts of interest | NR | |
Notes | Several reports of the same trial all with various bits of information. Study authors conclude that multiple intervention trial of this short duration did not change participants' behaviour. MI itself acts as a strong stimulus to alter behaviour with respect to risk factors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
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 | 24% lost to follow‐up; no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | Low risk | All outcomes reported at all time points. |