Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression

Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression Monitored by Smart Band: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Depression - Major Depressive Disorder
• Intervention / Treatment: Behavioral: Aerobic exercise

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weihua Yue, Doctor; Phone Number: 86-010-82805307; Email: dryue@bjmu.edu.cn
• Study Contact Backup: Name: Guorui Zhao; Phone Number: 86-13661352950; Email: grzhao@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Sixth Hostipal
      • Contact: Weihua Yue, Doctor; Phone Number: 010-82805307; Email: dryue@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise group; Aerobic exercise intervention combined with conventional drug treatment	Behavioral: Aerobic exercise; Moderate-intensity aerobic exercise for 30-50 minutes three times a week was added to usual medical therapy
No Intervention: Waiting control group; Antidepressants were routinely used and aerobic exercise interventions were performed at the end of the 8-week follow-up

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The reduction rate of HAMD-17 or MADRS score was ≥50%	Week 4 and 8 of treatment duration
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	Rating Scale for Side Effects (SERS) -Antidepressant	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	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	Week 0 and 8 of treatment duration
Body weight in kilograms		Week 4 and 8 of treatment duration
Body fat rate		Week 4 and 8 of treatment duration
Brain imaging features	Acquisition was performed by magnetic resonance imaging	Week 0 and 8 of treatment duration

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Aerobic exercise
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2024-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No