TReAtment With CombinedExercise in Patients With Resistant Major Depression

NCT05136027 | Unknown

• 1 other identifier: TRACE-RMD study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder is one of the most prevalent and disabling mental disorders worldwide. Forty percent of people with major depressive disorder are in moderate remission, with the remainder meeting the criteria for treatment-resistant depressive disorder (TRD), with an inadequate response to at least two different antidepressants of adequate dose and duration. Dysfunctionality in these individuals is frequent and severe and its importance contrasts with the absence of drugs to alleviate these deficits. Exercise programs, which were initially developed as interventions aimed at improving physical health in early stages or in mild symptomatology, have shown that they can also improve the symptoms of this disease in more advanced stages There is evidence of new therapeutic interventions for TRD. New pharmacological targets that aim to improve the evolution of depression and its functional repercussions augur that, in the future, new drugs will have to be combined with other therapeutic strategies, including exercise. Therefore, the objectives of this clinical trial with a control group are: 1) to analyze the changes in depressive symptoms in people diagnosed with TRD included in the exercise program compared to a control group; 2) to evaluate the improvement in physical health through cardiovascular risk factors and life expectancy suffered by this sector of the population, and 3) to analyze changes in functional status and quality of life. This is a prospective longitudinal intervention design (three months) in which people with TRD are included in two groups: 1) intervention with exercise (two days/week) and 2) control care with usual treatment. The aim is to find an improvement in mood and functionality with the implementation of exercise, as well as changes in physical areas such as blood pressure or body mass index, which are considered predictive factors of cardiovascular disease.

Conditions

Resistant Depression, Treatment

Keywords

Depression; Exercise; Low-intensity Interval Training; Resistance Training

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depressión Rating Scale (MADRS)

  Ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

  12 weeks

• Cardiorespiratory fitness

  Cardiorespiratory fitness evaluation measured by cardiopulmonary exercise test. Maximu oxygen uptake measured in mL/kg/min or L/min is the gold standard variable.

  12 weeks

Secondary Outcomes (3)

• Clinical Global Impression Scale (CGI)

  12 weeks

• Sheehan Disability Scale (SDS)

  12 weeks

• Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9)

  12 weeks

Study Arms (2)

Intervention group

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.

Other: Combined training

Attention Control

NO INTERVENTION

Regular in-hospital treatment with occupational activity sessions with the same frequency and duration as the intervention group.

Interventions

Combined training OTHER

Low-intensity interval training and resistance exercise

Intervention group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Depression major disorder.
• or more antdepressives resistant a treatment.
• Consent informed signed

You may not qualify if:

• Schizophrenia or other disorders.
• Suicide risk.
• Unstable medic illness or unsuitable controlled.
• Disorder for use of active substances.
• Comorbidity with other psychiatric pathologies.
• Montreal Cognitive Assessment \<26/30, cognitive deterioration.
• Incapacity for realizing physical exercise because of osteoarticular, cardiovascular, or metabolic difficulty.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Red Salud Mental Araba: collaborator

Study Sites (1)

Basque Country University

Vitoria-Gasteiz, Spain

RECRUITING

Related Publications (2)

• Tous-Espelosin M, Pavon-Navajas C, Etxaniz-Oses J, Canas-Garcia MT, Maldonado-Martin S, Orruno-Vivar J, Corres P, Iriarte-Yoller N. Effects of combined exercise training for adults with resistant major depression: a pilot study from the TRACE-RMD project. PeerJ. 2025 Nov 17;13:e20356. doi: 10.7717/peerj.20356. eCollection 2025.

  PMID: 41282982 DERIVED

• Iriarte-Yoller N, Etxaniz-Oses J, Pavon-Navajas C, Tous-Espelosin M, Sanchez-Gomez PM, Maldonado-Martin S, Yoller-Elburgo AB, Elizagarate-Zabala E. Treatment with combined exercise in patients with resistant major depression (TRACE-RMD): study protocol for a randomised controlled trial. Trials. 2024 Dec 18;25(1):827. doi: 10.1186/s13063-024-08685-7.

  PMID: 39696604 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• NAGORE IRIARTE-YOLLER, MD

  PSYCHIATRIC HOSPITAL OF ÁLAVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Maldonado-Martin, PhD

CONTACT

34945013534; sara.maldonado@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of laboratory, Principal Investigator

Model Details: Exercise group Atenttion Control

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 26, 2021
• Study Start: December 30, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: indefinite period
• Access Criteria: no criteria

Locations

ES (1)