Toobert 2000.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: USA Dates participants recruited: NR Maximum follow‐up: 24 months |
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Participants |
Inclusion criteria: Postmenopausal women with coronary heart disease, defined as atherosclerosis, MI, percutaneous transluminal coronary angioplasty, and/or coronary bypass graft surgery. Exclusion criteria: Other life‐threatening illnesses, infarction during the preceding 6 weeks, receiving streptokinase or alteplase, or being scheduled for bypass surgery. N randomised: total: 25; intervention: 14; comparator: 11 Diagnosis (% of participants): CHD: 100% Previous AMI: 52% PCI: 36% CABG: 28% Age (mean ±SD): intervention: 64 ± 10; comparator: 63 ± 11 Percentage male: 0% Ethnicity: 92% white |
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Interventions |
Intervention: Daily group physical activity sessions included warm‐up, walking or aerobics, and a cool‐down. Participants were individually prescribed exercise intensity based on their treadmill exercise test performance. Following the retreat, the intervention exercise programme required participants to engage in a 1‐hour session per day at least 3 days each week. Components: exercise, education and psychological support. Setting: supervised sessions in a centre followed by home. Exercise programme modality: walking or aerobics. Length of session: 1 hour. Frequency: daily and then at least 3 days a week. Intensity: individually prescribed. Resistance training included? no. Total duration: 24 months. Co‐interventions:. Participants randomised to the PrimeTime programme began the intervention with a 7‐day retreat. Women were encouraged to bring their partner. As well as physical activity, the daily schedule included cooking classes, instruction in stress‐management techniques including Hatha Yoga stretches, progressive deep relaxation, deep breathing, meditation, group support, smoking cessation and directed or receptive imagery.Twice‐weekly 4‐hour meetings followed the retreat with each meeting following a sequence similar to the retreat schedule. Comparator: usual care. Co‐interventions: none described. |
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Outcomes | Health‐related quality of life: SF‐36 at 24 months | |
Source of funding | National Heart, Lung, and Blood Institute | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized" |
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 | 3/28 (10.7%) participants lost to follow‐up; no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | High risk | While most outcomes are reported at all time points, the SF‐36 is poorly reported and it is not stated for which follow‐up the results are reported |