Seki 2003.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: Japan Dates participants recruited: NR Maximum follow‐up: 6 months |
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Participants |
Inclusion criteria: Male participants; > 65 years of age; with chronic CAD; referred at least 6 months after a major coronary event, including acute MI, coronary artery bypass grafting or percutaneous balloon angioplasty for acute coronary syndrome. Exclusion criteria: none described. N randomised: total: 38; intervention: 20; comparator: 18 Diagnosis (% of participants): Chronic CAD: 100% MI: 55% PCI: 39% CABG: 39% Age (mean ± SD): intervention: 69.3±2.9 ; comparator: 70.1±3.7 Percentage male: 100% Ethnicity: NR |
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Interventions |
Intervention: participants participated in an outpatient phase III CR program for 6 months. The weekly supervised exercise session at the clinic consisted of approximately 20 min of warm‐up exercises including stretching and callisthenics, followed by 20–30 min of continuous upright aerobic and dynamic exercise (various combinations of walking, bicycling, jogging, and other activities) and light isometric exercise, such as hand weights, and approximately 20 min of cool‐down stretching and callisthenics. The intensity of exercise was prescribed individually at the anaerobic threshold level measured by a symptom‐limited treadmill exercise test at baseline. In addition to the supervised exercise session, participants were encouraged to exercise twice a week outside of the clinic. Each participant’s exercise prescription was also periodically adjusted on the basis of repeated treadmill exercise test to encourage a gradual increase in overall exercise performance. Components: exercise and education. Setting: supervised in a centre and independent at home. Exercise programme modality: e.g. walking, bicycling, jogging. Length of session: 60‐70 min. Frequency: weekly at centre plus twice a week at home. Intensity: prescribed individually. Resistance training included? Callisthenics. Total duration: 6 months. Co‐interventions: participants were encouraged and interviewed at the supervised exercise session by physicians, dietitians, nurses, and exercise physiologists to comply with both the exercise and dietary education of the programme throughout its duration. Comparator: participants were followed by an individual physician as a usual outpatient. Co‐interventions: none described. |
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Outcomes | Health‐related quality of life at 6 months. | |
Source of funding | Health Sciences Research Grants from Ministry of Health and Welfare (Comprehensive Research on Aging and Health). | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned..by envelope method" |
Allocation concealment (selection bias) | Unclear risk | "randomly assigned..by envelope method" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 38 participants accounted for. |
Selective reporting (reporting bias) | Low risk | All outcomes are reported for all time points. |