Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression

Not Applicable

Recruiting

• Conditions: Depression - Major Depressive Disorder
• Interventions: Behavioral: Aerobic exercise

• Registration Number: NCT06594588
• Lead Sponsor: Peking University

Brief Summary

The goal of this project is to quantify the relative effectiveness of aerobic exercise monitored by smart wristbands in assisting the treatment of depression and improving cognitive function. It aims to explore the mechanisms through which aerobic exercise exerts its effects using imaging genetics and other methods, and to identify suitable populations for exercise, ultimately providing personalized clinical exercise prescriptions. This study will intervene from a behavioral perspective and also seeks to motivate participants to change and improve their physical activity habits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-10
• Study Start: 2024-09-12
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-05-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Aged 18-45 years (including 18 and 45), no gender restriction;
2. Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV);
3. Outpatients or inpatients; Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 14; Mood Disorder Questionnaire (MDQ) screening negative to exclude bipolar disorder patients; and Clinical Global Impressions-Severity (CGI-S) score ≥ 4;
4. Maintained on antidepressant treatment for at least 4 weeks or not using antidepressant treatment;
5. Written informed consent obtained from the patient.

Exclusion Criteria

1. Diagnosed with other mental disorders, including schizophrenia, bipolar disorder, alcohol or substance abuse/dependence, eating disorders, etc.;
2. Individuals with intellectual disabilities or who are unable to cooperate for other reasons, or those lacking or having incomplete civil capacity during the onset of illness;
3. Suffering from neurological or organic brain diseases (such as stroke, cerebral hemorrhage, brain tumors, Parkinson's disease, epilepsy, etc.) and a history of severe traumatic brain injury;
4. Suffering from conditions with high exercise risk, such as hypertension or heart disease;
5. Currently undergoing systematic psychological therapy;
6. In the 3-minute step test, males with a recovery heart rate >131 and females with a recovery heart rate >140;
7. Physically restricted individuals unable to participate in physical exercise;
8. Physical Activity Readiness Questionnaire (PAR-Q) score ≥ 2;
9. Pregnant women or individuals with contraindications to MRI examinations;
10. Individuals with severe suicidal tendencies or at risk of harming others.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic exercise group	Aerobic exercise	Aerobic exercise intervention combined with conventional drug treatment

Primary Outcome Measures

Name	Time	Method
Change from baseline in Hamilton Depression Rating Scale (HAMD)	Week 4 and 8 of treatment duration	The outcome is assessed by HAMD-17 Scale.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in THINC-it score	Week 4 and 8 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	Week 4 and 8 of treatment duration
Response to treatment	Week 4 and 8 of treatment duration	The reduction rate of HAMD-17 or MADRS score was ≥50%
Clinical Global Impression-Severity of Illness (CGI-S)	Week 4 and 8 of treatment duration
Change from baseline in Hamilton Anxiety Rating Scale (HAMA)	Week 4 and 8 of treatment duration
Change from baseline in Ruminative Responses Scale (RRS)	Week 4 and 8 of treatment duration
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)	Week 4 and 8 of treatment duration
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)	Week 4 and 8 of treatment duration
Rating Scale for Side Effects (SERS) -Antidepressant	Week 4 and 8 of treatment duration	Rating Scale for Side Effects (SERS) -Antidepressant
Mood Disorder Questionnaire (MDQ)	Week 4 and 8 of treatment duration
International Physical Activity Questionnaire (IPAQ)	Week 4 and 8 of treatment duration
Biomarkers level	Week 0 and 8 of treatment duration	CRP, IL-1β, TNF-α, IL-6, IL-8, IL-10 and other immune factors, irisin, neurotrophic factor BDNF, vascular endothelial growth factor VEGF, and insulin growth factor IGF-1, NLRP3, CXCL8, CXCL3, CCL5, etc
Body weight in kilograms	Week 4 and 8 of treatment duration
Body fat rate	Week 4 and 8 of treatment duration
Brain imaging features	Week 0 and 8 of treatment duration	Acquisition was performed by magnetic resonance imaging

Trial Locations

Locations (1)

Peking University Sixth Hostipal; 🇨🇳 Beijing, Beijing, China