TRACE-RMDExercise Program in Patients With Treatment-resistant Depressive Disorder Compared to Usual Practice
Combined training
Troubles Mentaux+1
+ Trouble Dépressif
+ Troubles de l'humeur
Étude thérapeutique
Résumé
Date de début de l'étude : 30 décembre 2022
Date à laquelle le premier participant a commencé l'étude.The presence of major depressive disorder (MDD) in today's society is worryingly high. Specifically, the prevalence-year prevalence of MDD in Spain is 3.9% and lifetime prevalence is 10.5%. The lifetime prevalence for men is 6.29% and 14.47% for women in Spain according to the ESEMED-Spain study. Although there is no explicit international consensus, the medical literature and research define treatment-resistant depression (TRD) as any MDD that does not respond to two trials of treatment antidepressant treatment at adequate doses and for an adequate duration of time. MDD is the leading cause of years lived with disability worldwide, accounting for 11.9%. It has been estimated that during the year 2020 it could be second only to ischemic heart disease in disability-adjusted life years lost. Given this bleak scenario, different non-pharmacological strategies have been considered as possible complementary treatments to pharmacological treatment to help improve the prognosis of MDD and remission rates, such as exercise and electroconvulsive therapy. Sedentary lifestyles are a very common feature in the severely mentally disordered population. One of the causes for this to occur is that people with MDD have very little confidence in their ability to exercise and lack the necessary social support. This inactivity together with other modifiable risk factors such as tobacco use, high blood pressure, and overweight/obesity, in addition to the side effects of pharmacological treatments contributes to the appearance of different diseases, as well as decreased life expectancy and quality of life. TRD can act as a cause or as a repercussion of physical inactivity. It has been recognized for several years that the performance of regular exercise is cardioprotective, decreasing the incidence of cardiovascular diseases such as arterial hypertension, coronary artery disease, type 2 diabetes, and atherosclerosis. In addition to being cardioprotective, exercise has shown a positive association with psychological well-being and therapeutic benefits in older people with depressive disorder, depressive symptoms in patients with Alzheimer's disease and MDD. Although there is still some controversy about the intensity and frequency of exercise, and the duration of the exercise program, the recommendations were the adoption of a moderate-intensity exercise program of at least 30 minutes on most days of the week, for 10-12 weeks. In the latest World Health Organization guidelines on physical activity (PA) and sedentary habits, for the improvement of quality of life in adults with TMD the general recommendations do not differ from the general population, i.e., people should accumulate throughout the week a minimum of 150-300 minutes of moderate aerobic PA or a minimum of 75-150 minutes of vigorous PA, or an equivalent combination of both in order to obtain notable health benefits. Also, in order to achieve additional health benefits, the participants should perform two days a week of moderate or higher intensity muscle-strengthening activities.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.70 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 78 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
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Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site