The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia

NCT07625163 | Not Yet Recruiting

• 1 other identifier: 680/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.To determine the effect of aerobic exercise interventions on depressive symptoms of individuals diagnosed with MDD.
2. 2.To determine the effect of aerobic exercise interventions on health-related quality of life among individuals diagnosed with MDD.
3. 3.To determine the effect of mindful breathing exercises on depressive symptoms among individuals diagnosed with MDD.
4. 4.To determine the effect of the mindful breathing exercise intervention on quality of life amongst individuals diagnosed with MDD.
5. 5.45 minutes of moderate AE (60-75% HRR);
6. 6.15 minutes of guided mindful breathing (6 breaths/minute);
7. 7.a waitlist control receiving standard care. \*Interventions will occur three times a week for 16 weeks.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder; Aerobic Exercise; Mindful Breathing; Quality of Life; Saudi Arabia

Outcome Measures

Primary Outcomes (1)

• Depressive symptom severity

  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

Secondary Outcomes (3)

• Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF)

  WHOQOL-BREF: baseline and week 16.

• Quality of life (QoL)2 : Anxiety Symptoms

  Baseline, Week 4,8, and a 16-week

• Quality of life (QoL) 3: Sleep Quality

  Baseline, Week 4, Week 8, and Week 16.

Study Arms (3)

Aerobic Exercise (AE)

EXPERIMENTAL

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.

Other: Aerobic exercise

Mindful Breathing (MB)

EXPERIMENTAL

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.

Other: Mindful Breathing

Control Group (Standard Care) Standard Treatment

OTHER

Participants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions.

Other: Aerobic exercise; Other: Mindful Breathing

Interventions

Aerobic exercise OTHER

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.

Also known as: walking, cardiovascular exercise

Aerobic Exercise (AE); Control Group (Standard Care) Standard Treatment

Mindful Breathing OTHER

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.

Also known as: diaphragmatic breathing, deep breathing

Control Group (Standard Care) Standard Treatment; Mindful Breathing (MB)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pretoria: lead

Study Sites (2)

Erada Hospital and Mental Health in Al Kharj

Al Kharj, Saudi Arabia

Location

Erada complex and Mental Health in Riyadh

Riyadh, Saudi Arabia

Location

Related Publications (10)

• 1. WHO. Depressive disorder (depression): World Health Organization; 2025 [Available from: https://www.who.int/news-room/fact-sheets/detail/depression.

  BACKGROUND

• GBD 2023 Demographics Collaborators. Global age-sex-specific all-cause mortality and life expectancy estimates for 204 countries and territories and 660 subnational locations, 1950-2023: a demographic analysis for the Global Burden of Disease Study 2023. Lancet. 2025 Oct 18;406(10513):1731-1810. doi: 10.1016/S0140-6736(25)01330-3. Epub 2025 Oct 12.

  PMID: 41092927 BACKGROUND

• Alnaim MA, Alghamdi AH, Aljawair MR, Alhadi FA, Alomair AM, Alsaad A. Depression among Saudi international university students and its associated risk factors. BMC Public Health. 2024 Nov 11;24(1):3101. doi: 10.1186/s12889-024-20565-y.

  PMID: 39523315 BACKGROUND

• Pigott HE, Kim T, Xu C, Kirsch I, Amsterdam J. What are the treatment remission, response and extent of improvement rates after up to four trials of antidepressant therapies in real-world depressed patients? A reanalysis of the STAR*D study's patient-level data with fidelity to the original research protocol. BMJ Open. 2023 Jul 25;13(7):e063095. doi: 10.1136/bmjopen-2022-063095.

  PMID: 37491091 BACKGROUND

• Romero Garavito A, Diaz Martinez V, Juarez Cortes E, Negrete Diaz JV, Montilla Rodriguez LM. Impact of physical exercise on the regulation of brain-derived neurotrophic factor in people with neurodegenerative diseases. Front Neurol. 2025 Jan 28;15:1505879. doi: 10.3389/fneur.2024.1505879. eCollection 2024.

  PMID: 39935805 BACKGROUND

• Komariah M, Ibrahim K, Pahria T, Rahayuwati L, Somantri I. Effect of Mindfulness Breathing Meditation on Depression, Anxiety, and Stress: A Randomized Controlled Trial among University Students. Healthcare (Basel). 2022 Dec 22;11(1):26. doi: 10.3390/healthcare11010026.

  PMID: 36611488 BACKGROUND

• 6. Muaythir SB, Bello B, Magida N. Effect of Aerobic Exercise on Depression Symptoms and Quality of Life in Patients with Major Depressive Disorder: A Systematic Review and Meta-Analysis

  BACKGROUND

• Marquez DX, Aguinaga S, Vasquez PM, Conroy DE, Erickson KI, Hillman C, Stillman CM, Ballard RM, Sheppard BB, Petruzzello SJ, King AC, Powell KE. A systematic review of physical activity and quality of life and well-being. Transl Behav Med. 2020 Oct 12;10(5):1098-1109. doi: 10.1093/tbm/ibz198.

  PMID: 33044541 BACKGROUND

• Elfil M, Negida A. Sampling methods in Clinical Research; an Educational Review. Emerg (Tehran). 2017;5(1):e52. Epub 2017 Jan 14.

  PMID: 28286859 BACKGROUND

• Jenkins DG, Quintana-Ascencio PF. A solution to minimum sample size for regressions. PLoS One. 2020 Feb 21;15(2):e0229345. doi: 10.1371/journal.pone.0229345. eCollection 2020.

  PMID: 32084211 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Exercise; Walking

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Locomotion

Study Officials

• Saad Bin Muaythir, Master

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saad A Bin Muaythir, Master

CONTACT

+966568200040; u24122336@tuks.co.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student in The Department of Physiotherapy, School of Healthcare Sciences, University of Pretoria

Model Details: Group 1: Aerobic Exercise (AE) Administration The AE protocol is designed to achieve the moderate-intensity threshold * Warm-up: 5-10 minutes of low-intensity walking. * Core Phase: 30 minutes of continuous aerobic activity (walking). * Cool-down: 5 minutes of slow walking and static stretching. Group II: Mindful Breathing (MB) Administration * Technique: Participants will be taught Diaphragmatic Resonant Breathing. This involves inhaling through the nose for 4 seconds and exhaling slowly for 6 seconds (approximately 6 breaths per minute). * Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze. Group III: Control Group (Standard Care) : Participants will continue their prescribed pharmacological treatment and any existing psychotherapy or physiotherapy sessions.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 4, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)