Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression

NCT06594588 | Recruiting

• 1 other identifier: 2024-11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression - Major Depressive Disorder

Keywords

Aerobic exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

• 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

Study Arms (2)

Aerobic exercise group

EXPERIMENTAL

Aerobic exercise intervention combined with conventional drug treatment

Behavioral: Aerobic exercise

Waiting control group

NO INTERVENTION

Antidepressants were routinely used and aerobic exercise interventions were performed at the end of the 8-week follow-up

Interventions

Aerobic exercise BEHAVIORAL

Moderate-intensity aerobic exercise for 30-50 minutes three times a week was added to usual medical therapy

Aerobic exercise group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-45 years (including 18 and 45), no gender restriction;
• Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
• 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;
• Maintained on antidepressant treatment for at least 4 weeks or not using antidepressant treatment;
• Written informed consent obtained from the patient.

You may not qualify if:

• Diagnosed with other mental disorders, including schizophrenia, bipolar disorder, alcohol or substance abuse/dependence, eating disorders, etc.;
• 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;
• 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;
• Suffering from conditions with high exercise risk, such as hypertension or heart disease;
• Currently undergoing systematic psychological therapy;
• In the 3-minute step test, males with a recovery heart rate more than131 and females with a recovery heart rate more than 140;
• Physically restricted individuals unable to participate in physical exercise;
• Physical Activity Readiness Questionnaire (PAR-Q) score ≥ 2;
• Pregnant women or individuals with contraindications to MRI examinations;
• Individuals with severe suicidal tendencies or at risk of harming others.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Sixth Hostipal

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Weihua Yue, Doctor

CONTACT

86-010-82805307; dryue@bjmu.edu.cn

Guorui Zhao

CONTACT

86-13661352950; grzhao@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 12, 2024
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)