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

Peking University1 site in 1 country80 target enrollmentSeptember 12, 2024

ConditionsDepression - Major Depressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depression - Major Depressive Disorder
Sponsor: Peking University
Enrollment: 80
Locations: 1
Primary Endpoint: Change from baseline in Hamilton Depression Rating Scale (HAMD)
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 12, 2024

End Date

December 30, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University

Responsible Party

Principal Investigator

Weihua Yue

Professor

Peking University Sixth Hospital

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.

Outcomes

Primary Outcomes

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

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)
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(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)
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)