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The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia (MDD/AE/MB)

1 de junho de 2026 atualizado por: Saad Bin Muaythir, University of Pretoria

The Effects of Aerobic Exercise and Mindful Breathing on Symptom Severity and Quality of Life in Individuals With Major Depressive Disorder in Saudi Arabia: A Randomised Clinical Trial Protocol

The goal of this Randomized Clinical Trial is to evaluate the effectiveness of aerobic exercise (AE) and mindful breathing (MB) on depressive symptom severity and quality of life (QoL), in adults with MDD. The main question is: Does aerobic exercise and mindful breathing delivery reduce depressive symptom severity and improve quality of life more effectively than standard psychiatric care? The aims to answer are:

  1. To determine the effect of aerobic exercise interventions on depressive symptoms of individuals diagnosed with MDD.
  2. To determine the effect of aerobic exercise interventions on health-related quality of life among individuals diagnosed with MDD.
  3. To determine the effect of mindful breathing exercises on depressive symptoms among individuals diagnosed with MDD.
  4. To determine the effect of the mindful breathing exercise intervention on quality of life amongst individuals diagnosed with MDD.

Participants will be randomized into three groups:

  1. 45 minutes of moderate AE (60-75% HRR);
  2. 15 minutes of guided mindful breathing (6 breaths/minute);
  3. a waitlist control receiving standard care. *Interventions will occur three times a week for 16 weeks.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Major Depressive Disorder (MDD) is a leading cause of global disability, with many patients showing suboptimal responses to conventional pharmacological treatments. Evidence suggests that aerobic exercise (AE) and mindful breathing (MB) can serve as powerful non-pharmacological modulators of the central and autonomic nervous systems. This protocol outlines a randomized clinical trial (RCT) to evaluate the individual and synergistic effects of these interventions in a Saudi Arabian clinical population.

Major Depressive Disorder (MDD) is no longer viewed merely as a psychological condition but as a systemic, multi-faceted public health crisis. According to the World Health Organization and the latest Global Burden of Disease (GBD) analysis, MDD is a primary driver of global disability, defined by persistent feelings of sadness, anhedonia, sleep disturbances, and diminished capacity for daily functioning . Globally, it affects more than 280 million people.

In Saudi Arabia, the rising prevalence of MDD necessitates a shift toward "Integrative Psychiatry," where lifestyle medicine serves as a core pillar. Despite the availability of pharmacological and psychotherapeutic treatments, many individuals experience suboptimal outcomes, relapse, or treatment resistance, with the STAR*D study highlighting that only about one-third of patients achieve full remission after their first course of antidepressant medication . Furthermore, the side effects of conventional medications, such as weight gain and metabolic syndrome, often lead to premature discontinuation.

While the individual antidepressant effects of exercise and mindful breathing are well-documented, significant gaps remain. Existing literature indicates that AE "primes" the brain by increasing neuroplasticity and reward processing. Mindful breathing, conversely, stabilizes the autonomic nervous system and reduces anxiety. Combining these two low-cost, non-pharmacological interventions may provide a superior "biopsychosocial" approach to MDD recovery that neither could achieve alone. Modern psychiatry recognizes that a patient can be "less depressed" while still having a poor Quality of Life (QoL). Exercise is uniquely positioned to improve QoL because its benefits are "transdiagnostic", improving physical vitality, sleep quality, and social engagement simultaneously.

and a baseline Hamilton Depression Rating Scale (HAM-D) score ≥ 17.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Arábia Saudita
      • Al Kharj, Arábia Saudita
        • Erada Hospital and Mental Health in Al Kharj
        • Contato:
      • Riyadh, Arábia Saudita
        • Erada complex and Mental Health in Riyadh
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Adults aged 18-60 years with a formal diagnosis of Major Depressive Disorder (MDD) based on DSM-5-TR or ICD-10 criteria.
  2. A baseline score of ≥ 17 on the Hamilton Depression Rating Scale (HAM-D) is required to ensure a moderate-to-severe symptom profile

Exclusion Criteria:

  1. Patients with high suicidal ideation
  2. Patients with a history of psychosis or bipolar disorder
  3. Patient with physical contraindications to exercise (e.g., unstable cardiovascular disease).
  4. Concurrent participation in other structured exercise/mindfulness trials.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Aerobic Exercise (AE)

The AE protocol is designed to achieve the moderate-intensity threshold (SMD = -0.91), which has been identified as the most effective for symptom reduction (16).

  • Warm-up: 5-10 minutes of low-intensity walking and dynamic stretching.
  • Core Phase: 30 minutes of continuous aerobic activity (walking or Stationary Cycling).
  • Intensity Monitoring: Heart rate (HR) will be monitored using wearable sensors. Target intensity is set at 60-75% of the Heart Rate Reserve (HRR) or a Rating of Perceived Exertion (RPE) of 12-14 on the Borg Scale.
  • Cool-down: 5 minutes of slow walking and static stretching.
Outro: Aerobic exercise
Aerobic or cardiovascular exercise is characterized by activities that engage large muscle groups, including walking, jogging, or cycling. Regular aerobic exercise can improve cardiovascular health, endurance, and overall fitness.
Outros nomes:
  • andando
  • cardiovascular exercise
Experimental: Mindful Breathing (MB)

The MB protocol focuses on "Top-Down" emotional regulation and "Bottom-Up" autonomic stabilisation.

  • Technique: Participants will be taught Diaphragmatic Resonant Breathing. This involves inhaling through the nose for four (4) seconds and exhaling slowly for six (6) seconds (approximately 6 deep breaths per minute).
  • Mindfulness Component: During the breathing, participants are instructed to maintain "non-judgmental awareness," acknowledging stray thoughts and gently returning focus to the sensation of air entering and leaving the body.
  • Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze.
Outro: Mindful Breathing
Mindful breathing can include diaphragmatic breathing, deep breathing, and controlled breathing techniques, which focus on regulating and optimizing the process of inhalation and exhalation. These techniques enhance respiratory function, increase lung capacity, and promote relaxation by activating the parasympathetic nervous system. Therefore, they have been used in various therapeutic contexts to manage stress, anxiety, and mood disorders, including MDD, by regulating emotions and the stress response.
Outros nomes:
  • respiração profunda
  • respiração diafragmática
Outro: Control Group (Standard Care) Standard Treatment
Participants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions.
Outro: Aerobic exercise
Aerobic or cardiovascular exercise is characterized by activities that engage large muscle groups, including walking, jogging, or cycling. Regular aerobic exercise can improve cardiovascular health, endurance, and overall fitness.
Outros nomes:
  • andando
  • cardiovascular exercise
Outro: Mindful Breathing
Mindful breathing can include diaphragmatic breathing, deep breathing, and controlled breathing techniques, which focus on regulating and optimizing the process of inhalation and exhalation. These techniques enhance respiratory function, increase lung capacity, and promote relaxation by activating the parasympathetic nervous system. Therefore, they have been used in various therapeutic contexts to manage stress, anxiety, and mood disorders, including MDD, by regulating emotions and the stress response.
Outros nomes:
  • respiração profunda
  • respiração diafragmática

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Depressive symptom severity
Prazo: Baseline, Week 4,8, and a 16-week

Depressive symptom severity will be assessed using the Hamilton Depression Rating Scale (HAM-D), with total scores ranging from 0 to 52. Higher scores indicate more severe depressive symptoms.

For MDD, a baseline Hamilton Depression Rating Scale (HAM-D) score of ≥ 17 is required. Reduction in Hamilton Depression Rating Scale (HAM-D) scores is the primary outcome measure.
Baseline, Week 4,8, and a 16-week

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF)
Prazo: WHOQOL-BREF: baseline and week 16.
Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), which generates domain scores transformed to a scale ranging from 0 to 100. Higher scores indicate a better quality of life
WHOQOL-BREF: baseline and week 16.
Quality of life (QoL)2 : Anxiety Symptoms
Prazo: Baseline, Week 4,8, and a 16-week
Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire with total scores ranging from 0 to 63. Higher scores indicate greater anxiety severity.
Baseline, Week 4,8, and a 16-week
Quality of life (QoL) 3: Sleep Quality
Prazo: Baseline, Week 4, Week 8, and Week 16.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Baseline, Week 4, Week 8, and Week 16.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Pretoria

Investigadores

  • Investigador principal: Saad Bin Muaythir, Master

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

14 de outubro de 2026

Conclusão do estudo (Estimado)

14 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 680/2024

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Indirect identifiers will be used through coded participant IDs. Direct identifiers will be stored separately from research data. Use participant codes on all study forms; store consent forms separately; keep electronic data on password-protected/encrypted devices or servers; keep paper CRFs in locked cabinets; restrict access to PI and authorized research staff only.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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