Evidence map›Paper›PMID 39696604›Full record

ArticleTrials2024

Treatment with combined exercise in patients with resistant major depression (TRACE-RMD): study protocol for a randomised controlled trial.

Nagore Iriarte-Yoller, José Etxaniz-Oses, Cristobal Pavón-Navajas, Mikel Tous-Espelosin, Pedro M Sánchez-Gómez, Sara Maldonado-Martín, Ana B Yoller-Elburgo, Edorta Elizagarate-Zabala

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05136027 (Exercise Program in Patients With Treatment-resistant Depressive Disorder Compared to Usual Practice), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05136027 naunknown statusnot on this map

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

TypeinterventionalSponsorUniversity of the Basque Country (UPV/EHU)Ran2022 to 2024Enrolled70ConditionsResistant Depression, TreatmentArmsCombined training
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Nagore Iriarte-YollerOsakidetza Basque Health Service, Araba Mental Health Network, Psychiatric Hospital of Alava, Vitoria-Gasteiz, Spain.
José Etxaniz-OsesDepartment of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, GIzartea, Kirola eta Ariketa Fisikoa Ikerkuntza Taldea (GIKAFIT), Society, Sports, and Exercise Research Group, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.
Cristobal Pavón-NavajasOsakidetza Basque Health Service, Araba Mental Health Network, Psychiatric Hospital of Alava, Vitoria-Gasteiz, Spain.
Mikel Tous-EspelosinDepartment of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, GIzartea, Kirola eta Ariketa Fisikoa Ikerkuntza Taldea (GIKAFIT), Society, Sports, and Exercise Research Group, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.
Pedro M Sánchez-GómezBioaraba, New Therapies in Mental Health Group, Vitoria-Gasteiz, Spain.
Sara Maldonado-MartínDepartment of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, GIzartea, Kirola eta Ariketa Fisikoa Ikerkuntza Taldea (GIKAFIT), Society, Sports, and Exercise Research Group, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain. sara.maldonado@ehu.eus.
Ana B Yoller-ElburgoOsakidetza Basque Health Service, Araba Mental Health Network, Psychiatric Hospital of Alava, Vitoria-Gasteiz, Spain.
Edorta Elizagarate-ZabalaOsakidetza Basque Health Service, Araba Mental Health Network, Psychiatric Hospital of Alava, Vitoria-Gasteiz, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAround 40% of people with major depressive disorder (MDD) experience moderate remission, with the remainder meeting the criteria for resistant major depression (RMD). It has been shown that exercise has a low-to-moderate effect on MDD, but there is a lack of evidence on exercise interventions in RMD patients. The primary purpose of the proposed study will be to investigate the effect of a 12-week supervised combined exercise program on depressive symptoms in people with RMD compared to a treatment-as-usual (TAU) group.

methodThis randomised, single-blind, controlled experimental trial will include 70 adults (≥ 18 years old) with RMD. Participants randomised to an exercise intervention, or a TAU group will be assessed at baseline and after a three-month intervention period. The primary variable will be participants' depressive symptoms measured with the Montgomery-Asberg Depression Rating Scale. Secondary outcome variables will include cardiorespiratory fitness (peak oxygen uptake through peak cardiopulmonary exercise test), body composition (bioimpedance and anthropometric variables), physical activity level (the International Physical Activity Questionnaire), health-related quality of life (the Short Form-36 Health Survey), functional outcome (the Sheehan Disability Scale and Quality of Life in Depression Scale), overall disease severity (the Clinical Global Impression Scale-Severity of Illness), and biochemical variables (a fasting blood sample). DISCUSSION: This study will try to answer whether a supervised co-adjuvant combined (aerobic and resistance training) exercise program will help the prognosis of this population with RMD.

trial registrationClinicalTrials.gov NCT05136027. Last public release on 12/13/2023.

Indexed as

Depressive Disorder, Treatment-ResistantExercise TherapyMajor Depressive DisorderQuality of LifeRandomized Controlled Trials as TopicAdultCardiorespiratory FitnessFemaleHumansMaleMiddle AgedSingle-Blind MethodTime FactorsTreatment OutcomeCombined trainingExerciseQuality of lifeRandomised controlled trialResistant major depression

Identifiers

PMID39696604
PMCPMC11653556

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.