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

2026年6月1日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Saad A Bin Muaythir, Master
  • 電話番号：+966568200040
  • メール：u24122336@tuks.co.za

研究場所

  • サウジアラビア
      • Al Kharj、サウジアラビア
        • Erada Hospital and Mental Health in Al Kharj
        • コンタクト：
      • Riyadh、サウジアラビア
        • Erada complex and Mental Health in Riyadh
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：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.
他の名前：
  • ウォーキング
  • cardiovascular exercise
実験的：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.
他の：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.
他の名前：
  • 深呼吸
  • 横隔膜呼吸
他の：Control Group (Standard Care) Standard Treatment
Participants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions.
他の：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.
他の名前：
  • ウォーキング
  • cardiovascular exercise
他の：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.
他の名前：
  • 深呼吸
  • 横隔膜呼吸

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Depressive symptom severity
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF)
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Pretoria

捜査官

  • 主任研究者：Saad Bin Muaythir, Master

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月15日

一次修了 (推定)

2026年10月14日

研究の完了 (推定)

2026年11月14日

試験登録日

最初に提出

2026年5月27日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 680/2024

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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