Depression - Major Depressive Disorder
Conditions
Keywords
Aerobic exercise
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.
Interventions
BEHAVIORALAerobic exercise
Moderate-intensity aerobic exercise for 30-50 minutes three times a week was added to usual medical therapy
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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-V); 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 more than131 and females with a recovery heart rate more than 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change from baseline in THINC-it score | Week 4 and 8 of treatment duration | — |
| 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 |
| Rating Scale for Side Effects (SERS) -Antidepressant | Week 4 and 8 of treatment duration | Rating Scale for Side Effects (SERS) -Antidepressant |
Countries
China
Contacts
Primary ContactWeihua Yue, Doctor
Backup ContactGuorui Zhao
Outcome results
None listed