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Идёт набор NCT06594588

Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression

Без фазы С лечением Depression - Major Depressive Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Aerobic exercise.
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University Sixth Hostipal — Пекин

Идентификаторы

NCT: NCT06594588 · 2024-11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗