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TReAtment With Concurrent Exercise in Patients With Resistant Major Depression (TRACE-RMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05136027
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Collaborator:
Red Salud Mental Araba
Information provided by (Responsible Party):
SARA MALDONADO-MARTIN, University of the Basque Country (UPV/EHU)

Brief Summary:
The aim is to apply an exercise program to study symptomatic and physical changes, as well as to evaluate the improvement in functionality in a resistant depression unit. Sample: 20 patients with the resistant major depressive disorder who will undergo an exercise program. Before and after 12 weeks of intervention, the participants will be assessed with clinical, physical, physiological, biochemical, and functional variables. During 3 months the exercise program will be implemented 2 days per week. It is expected to find an improvement in mood and functionality, as well as changes in physical areas such as blood pressure or body mass index, which are considered predictive factors of cardiovascular disease.

Condition or disease Intervention/treatment Phase
Resistant Depression, Treatment Other: Concurrent training Not Applicable

Detailed Description:

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. TDM 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Physical exercise group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Treatment With Concurrent Exercise in Patients With Resistant Major Depression
Estimated Study Start Date : January 30, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Intervention group: In the physical exercise session will carry out a concurrent training in four parts, low- intensity interval training in a bicycle, resistance circuit training, ow- intensity interval training in a bicycle, and CORE exercises.
Other: Concurrent training
Low intensity interval training and resistance exercise




Primary Outcome Measures :
  1. Montgomery-Asberg Depressión Rating Scale (MADRS) [ Time Frame: 12 weeks ]

    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


  2. Cardiorespiratory fitness [ Time Frame: 12 weeks ]
    Cardiorespiratory fitness evaluation measured by cardiopulmonary exercise test. Maximu oxygen uptake measured in mL/kg/min or L/min is the gold standard variable.


Secondary Outcome Measures :
  1. Clinical Global Impression Scale (CGI) [ Time Frame: 12 weeks ]
    The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. Its 3 items assess, 1) Severity of Illness (CGI-S), 2) Global Improvement (CGI-I), and 3) Efficacy Index (CGI-E, which is a measure of treatment effect and side effects specific to drugs that were administered).

  2. Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ]

    five-item, self-rated questionnaire designed to measure the extent to which a patient's disability due to an illness or health problem interferes with work/school, social life/leisure activities, and family life/home responsibilities.

    Total score 0-30 (0 unimpaired, 30 highly impaired) Work/school (0-10) Social life (0-10) Family life/home responsibilities (0-10 Scores of ≥5 on any of the 3 scales; high scores are associated with significant functional impairment.


  3. Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) [ Time Frame: 12 weeks ]
    To measure patients' satisfaction with medication



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136027


Contacts
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Contact: Sara Maldonado-Martin, PhD 34945013534 sara.maldonado@ehu.eus

Locations
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Spain
Basque Country University Recruiting
Vitoria Gasteiz, Spain
Contact: Sara Maldonado-Martín    34945013534    sara.maldonado@ehu.eus   
Sponsors and Collaborators
University of the Basque Country (UPV/EHU)
Red Salud Mental Araba
Investigators
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Principal Investigator: NAGORE IRIARTE-YOLLER, MD PSYCHIATRIC HOSPITAL OF ÁLAVA
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Responsible Party: SARA MALDONADO-MARTIN, Head of laboratory, Principal Investigator, University of the Basque Country (UPV/EHU)
ClinicalTrials.gov Identifier: NCT05136027    
Other Study ID Numbers: TRACE-RMD study
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A protocol paper will be written once the clinical trials identification number will be defined
Supporting Materials: Study Protocol
Time Frame: indefinite period
Access Criteria: no criteria

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SARA MALDONADO-MARTIN, University of the Basque Country (UPV/EHU):
Depression
Physical Exercise
Low-intensity Interval Training
Resistance Training
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders