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NCT Number: NCT06594588

Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Sixth Hostipal

Beijing, Beijing Municipality, 100191, China

Location status: Recruiting

Location contact

Weihua Yue, Doctor

CONTACT

[email protected]

010-82805307

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Aerobic Exercise

Behavioral

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

Primary outcomes

  1. Change from baseline in Hamilton Depression Rating Scale (HAMD)

    Time frame: Week 4 and 8 of treatment duration

    The outcome is assessed by HAMD-17 Scale.

Secondary outcomes

  1. Change from baseline in THINC-it score

    Time frame: Week 4 and 8 of treatment duration

  2. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: Week 4 and 8 of treatment duration

  3. Response to treatment

    Time frame: Week 4 and 8 of treatment duration

    The reduction rate of HAMD-17 or MADRS score was ≥50%

  4. Clinical Global Impression-Severity of Illness (CGI-S)

    Time frame: Week 4 and 8 of treatment duration

  5. Change from baseline in Hamilton Anxiety Rating Scale (HAMA)

    Time frame: Week 4 and 8 of treatment duration

  6. Change from baseline in Ruminative Responses Scale (RRS)

    Time frame: Week 4 and 8 of treatment duration

  7. Change from baseline in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Week 4 and 8 of treatment duration

  8. Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: Week 4 and 8 of treatment duration

  9. Rating Scale for Side Effects (SERS) -Antidepressant

    Time frame: Week 4 and 8 of treatment duration

    Rating Scale for Side Effects (SERS) -Antidepressant

  10. Mood Disorder Questionnaire (MDQ)

    Time frame: Week 4 and 8 of treatment duration

  11. International Physical Activity Questionnaire (IPAQ)

    Time frame: Week 4 and 8 of treatment duration

  12. Biomarkers level

    Time frame: 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

  13. Body weight in kilograms

    Time frame: Week 4 and 8 of treatment duration

  14. Body fat rate

    Time frame: Week 4 and 8 of treatment duration

  15. Brain imaging features

    Time frame: Week 0 and 8 of treatment duration

    Acquisition was performed by magnetic resonance imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Guorui Zhao

CONTACT

[email protected]

86-13661352950

Weihua Yue, Doctor

CONTACT

[email protected]

86-010-82805307

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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