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Recruiting NCT06594588

Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression

No phase Interventional Depression - Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic exercise.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Change from baseline in Hamilton Depression Rating Scale (HAMD) [Time frame: Week 4 and 8 of treatment duration]
Secondary outcome measures (12)
  • Change from baseline in THINC-it score [Time frame: Week 4 and 8 of treatment duration]
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [Time frame: Week 4 and 8 of treatment duration]
  • Response to treatment [Time frame: Week 4 and 8 of treatment duration]
  • Clinical Global Impression-Severity of Illness (CGI-S) [Time frame: Week 4 and 8 of treatment duration]
  • Change from baseline in Hamilton Anxiety Rating Scale (HAMA) [Time frame: Week 4 and 8 of treatment duration]
  • Change from baseline in Ruminative Responses Scale (RRS) [Time frame: Week 4 and 8 of treatment duration]
  • Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [Time frame: Week 4 and 8 of treatment duration]
  • Change from baseline in Connor-Davidson Resilience Scale (CD-RISC) [Time frame: Week 4 and 8 of treatment duration]
  • Rating Scale for Side Effects (SERS) -Antidepressant [Time frame: Week 4 and 8 of treatment duration]
  • Mood Disorder Questionnaire (MDQ) [Time frame: Week 4 and 8 of treatment duration]
  • International Physical Activity Questionnaire (IPAQ) [Time frame: Week 4 and 8 of treatment duration]
  • Biomarkers level [Time frame: Week 0 and 8 of treatment duration]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Sixth Hostipal — Beijing

Identifiers

NCT: NCT06594588 · 2024-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗