Suspended

TRACE-RMDExercise Program in Patients With Treatment-resistant Depressive Disorder Compared to Usual Practice

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Combined training

Other
Who is being recruted

Behavior+5

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 78 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2022
See protocol details

Summary

Principal SponsorUniversity of the Basque Country (UPV/EHU)
Study ContactSara Maldonado-Martin, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 30, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleExercise Program in Patients With Treatment-resistant Depressive Disorder Compared to Usual Practice
NCT05136027
Principal SponsorUniversity of the Basque Country (UPV/EHU)
Study ContactSara Maldonado-Martin, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 78 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsDepressionDepressive DisorderMotor ActivityMood DisordersDepressive Disorder, Treatment-Resistant

Criteria

3 inclusion criteria required to participate
Depression major disorder.

2 or more antdepressives resistant a treatment.

Consent informed signed

7 exclusion criteria prevent from participating
Schizophrenia or other disorders.

Suicide risk.

Unstable medic illness or unsuitable controlled.

Disorder for use of active substances.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention group: In the exercise session will carry out a combined training in four parts, low- intensity interval training in a bicycle, resistance circuit training, low- intensity interval training in a bicycle, and CORE exercises.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Basque Country University

Vitoria-Gasteiz, SpainOpen Basque Country University in Google Maps
SuspendedOne Study Center