Understanding prognostic benefits of exercise and antidepressant therapy for persons with depression and heart disease: the UPBEAT study — rationale, design, and methodological issues
Key result
The UPBEAT study is a randomized clinical trial of 200 patients designed to evaluate the effects of aerobic exercise or sertraline versus placebo on depression and cardiovascular biomarkers.
Why the study?
Does aerobic exercise or sertraline improve depressive symptoms and cardiovascular risk biomarkers in stable CHD patients with elevated depressive symptoms?
Population
200 stable coronary heart disease (CHD) patients with scores on the Beck Depression Inventory (BDI) >=9
Comparison
4 months of treatment with aerobic exercise or… vs Placebo
Design
Other, randomized
Follow-up
4 months
Authors
Discussion
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Member takes
Implication
Small RCT tests exercise/sertraline on depression and biomarkers in CHD; leaves open effects on clinical outcomes.
Study Design
Type
RCT (n=200)
Randomization
randomized
Structured PICO
Does aerobic exercise or sertraline improve depressive symptoms and cardiovascular risk biomarkers in stable CHD patients with elevated depressive symptoms?
P
Population
200 stable CHD patients with elevated depressive symptoms (BDI ≥9) randomized to 4 months of treatment with aerobic exercise, sertraline, or placebo.
I
Intervention
4 months of treatment with aerobic exercise or sertraline
C
Comparator
Placebo
O
Outcome
Depressive symptoms determined by clinical ratings on the Hamilton Rating Scale for Depression (HAM-D) and measures of heart rate variability (HRV), baroreflex control (BRC), vascular function (flow-mediated dilation [FMD]), and measures of inflammation and platelet aggregationsurrogate
The UPBEAT study is designed to evaluate whether exercise or sertraline improves depressive symptoms and cardiovascular biomarkers in CHD patients, though it is not powered for hard clinical outcomes.
Limitations
- This study is not powered to assess treatment group differences in CHD morbidity and mortality.
- Intermediate endpoints are not equivalent to 'hard' clinical events and further studies are needed to determine the clinical significance of these biomarkers.
Cite This Study
Blumenthal et al. (2007) conducted an RCT in coronary heart disease and elevated depressive symptoms (n=200). aerobic exercise or sertraline vs. placebo was evaluated on Depressive symptoms (HAM-D) and measures of heart rate variability, baroreflex control, vascular function, inflammation, and platelet aggregation. The UPBEAT study is a randomized clinical trial of 200 patients designed to evaluate the effects of aerobic exercise or sertraline versus placebo on depression and cardiovascular biomarkers.