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

Sponsor

University of the Basque Country (UPV/EHU) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05136027

Collaborator

Red Salud Mental Araba (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Physical exercise groupPhysical exercise group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Treatment With Concurrent Exercise in Patients With Resistant Major Depression

Anticipated Study Start Date :

Jan 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Montgomery-Asberg Depressión Rating Scale (MADRS) [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
Cardiorespiratory fitness [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

Clinical Global Impression Scale (CGI) [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).
Sheehan Disability Scale (SDS) [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.
Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) [12 weeks]
To measure patients' satisfaction with medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.