[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639540":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":79,"collaborators":41,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":41,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":106,"whyStopped":41,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Pretoria","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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).\n\n* Warm-up: 5-10 minutes of low-intensity walking and dynamic stretching.\n* Core Phase: 30 minutes of continuous aerobic activity (walking or Stationary Cycling).\n* 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.\n* Cool-down: 5 minutes of slow walking and static stretching.",[13],"Other: Aerobic exercise",{"label":15,"type":10,"description":16,"interventionNames":17},"Mindful Breathing (MB)","The MB protocol focuses on \"Top-Down\" emotional regulation and \"Bottom-Up\" autonomic stabilisation.\n\n* 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).\n* 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.\n* Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze.",[18],"Other: Mindful Breathing",{"label":20,"type":6,"description":21,"interventionNames":22},"Control Group (Standard Care) Standard Treatment","Participants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions.",[13,18],[24,31],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"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.",[9,20],[29,30],"walking","cardiovascular exercise",{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"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.",[20,15],[36,37],"diaphragmatic breathing","deep breathing",[39],{"name":40,"affiliation":41,"role":42},"Saad Bin Muaythir, Master",null,"PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":41,"email":48},"Saad A Bin Muaythir, Master","CONTACT","+966568200040","u24122336@tuks.co.za",[50,66],{"facility":51,"status":41,"city":52,"state":41,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Erada Hospital and Mental Health in Al Kharj","Al Kharj","Saudi Arabia","SA",{"type":56,"coordinates":57},"Point",[58,59],47.33457,24.15541,{"lat":59,"lon":58},[62],{"name":63,"role":46,"phone":64,"phoneExt":41,"email":65},"Dawood F Aldawood","+966505109089","dfaldawood@moh.gov.sa",{"facility":67,"status":41,"city":68,"state":41,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Erada complex and Mental Health in Riyadh","Riyadh",{"type":56,"coordinates":70},[71,72],46.72185,24.68773,{"lat":72,"lon":71},[75],{"name":76,"role":46,"phone":77,"phoneExt":41,"email":78},"Salwa M Abdulrahim","+966508832162","sabdulrahim@moh.gov.sa",{"type":42,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Saad Bin Muaythir","Doctoral student in The Department of Physiotherapy, School of Healthcare Sciences, University of Pretoria","100639540","the-effects-of-aerobic-exercise-and-mindful-breathing-on-individuals-with-major-depressive-disorder-in-saudi-arabia-100639540",false,"NCT07625163","The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia","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","MDD\u002FAE\u002FMB","Inclusion Criteria:\n\n1. Adults aged 18-60 years with a formal diagnosis of Major Depressive Disorder (MDD) based on DSM-5-TR or ICD-10 criteria.\n2. A baseline score of ≥ 17 on the Hamilton Depression Rating Scale (HAM-D) is required to ensure a moderate-to-severe symptom profile\n\nExclusion Criteria:\n\n1. Patients with high suicidal ideation\n2. Patients with a history of psychosis or bipolar disorder\n3. Patient with physical contraindications to exercise (e.g., unstable cardiovascular disease).\n4. Concurrent participation in other structured exercise\u002Fmindfulness trials.","ALL","18 Years","60 Years",{"count":94,"type":95},60,"ESTIMATED","INTERVENTIONAL",[98],"NA","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:\n\n1. To determine the effect of aerobic exercise interventions on depressive symptoms of individuals diagnosed with MDD.\n2. To determine the effect of aerobic exercise interventions on health-related quality of life among individuals diagnosed with MDD.\n3. To determine the effect of mindful breathing exercises on depressive symptoms among individuals diagnosed with MDD.\n4. To determine the effect of the mindful breathing exercise intervention on quality of life amongst individuals diagnosed with MDD.\n\nParticipants will be randomized into three groups:\n\n1. 45 minutes of moderate AE (60-75% HRR);\n2. 15 minutes of guided mindful breathing (6 breaths\u002Fminute);\n3. a waitlist control receiving standard care. \\*Interventions will occur three times a week for 16 weeks.",[101],"Major Depressive Disorder (MDD)",[103,104,32,105,53],"Major Depressive Disorder","Aerobic Exercise","Quality of Life","NOT_YET_RECRUITING","2026-06-01",{"date":109,"type":110},"2026-06-04","ACTUAL",{"date":112,"type":95},"2026-06-15",{"date":114,"type":95},"2026-11-14",{"name":5,"class":6},2]