Abstract
BACKGROUND: Although currently available evidence suggests that physical exercise can be beneficial for depressed patients and might be comparable to antidepressant treatment, the best way of implementing this recommendation in clinical practice is not known. This study therefore aims to ascertain the non-inferiority of supervised physical exercise to antidepressant drug treatment, in terms of reducing depressive symptoms among patients presenting with clinical criteria of a depressive episode (ICD-10), across a follow-up period of 6 months. METHODS: It will take the form of a randomised clinical trial undertaken in a primary care setting, in which a total of 312 patients over the age of 65 years with clinically significant depression will be randomly assigned to supervised physical exercise programme, or will alternatively receive treatment with antidepressant drugs habitually used in clinical practice. Participants' physical condition will be assessed at baseline, and again at 15 days and 1, 3 and 6 months. The supervised exercise programme will consist of 2 weekly sessions in groups of 10-12 patients across a period of 6 months, in which a sports instructor will train patients to do at least 30 min of regular activity at moderate intensity on an almost daily basis, including aerobic, muscle-strengthening, flexibility, and balance-strengthening exercises. The following will be assessed at regular intervals in both groups: status of depression symptoms; level of physical activity; self-perceived health status; appearance of adverse effects; and adherence to the physical exercise programme or antidepressant treatment. The principal outcome variable will be a reduction in pre-treatment depression-symptom scale scores (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale). DISCUSSION: In terms of the number of patients and duration of follow-up, this proposed clinical trial is a project which easily surpasses the few studies on this subject that have been previously conducted on the elderly. Its aim is to provide solid scientific evidence on a therapeutic resource -physical exercise- which has undeniable health benefits and can be applied to certain health problems, such as depressive disorders, which are of great magnitude and considerable socio-economic relevance, and have a significant impact on the quality of life of older adults. TRIAL REGISTRATION: ClinicalTrials.gov NCT03358433 (retrospectively registered on 11/25/2017).