Идёт набор NCT07340281

Biomarkers for Exercise

Без фазы С лечением Anxiety Disorders

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: Exercise Intervention.
Кому может быть актуально: Состояния в реестре: Anxiety Disorders. Базовые параметры: 18 лет — 50 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Examining Novel Biomarkers of Neuroplasticity Associated With Exercise in Adults With Anxiety Disorders

Обзор

The overarching objective is to examine the brain-based biological mechanistic pathway by which exercise exerts anxiolytic effects. The investigators will measure brain-derived markers of mitochondrial metabolism (acetyl-L-carnitine \[LAC\]) and inflammation (interleukin-6 \[IL-6\]) using innovative technology to isolate neuronal exosomes.

Вмешательства

Поведенческое Exercise Intervention
Exercise intervention is delivered in weekly individual sessions virtually for the 4-week intervention period. Sessions range from 25-45 minutes. The sessions serve as touch base points to review exercise for the week, plan for the coming week, problem-solve obstacles, and discuss various motivational strategies to help with an exercise routine. Participants are prescribed 150 minutes of moderate intensity exercise per week to be completed at home.

Первичные конечные точки

Acetyl-L-carnitine (LAC) Levels [Срок оценки: Week 4]
Interleukin-6 (IL-6) Levels [Срок оценки: Week 4]

Вторичные конечные точки (10)

Continuously measured moderate/vigorous minutes of exercise [Срок оценки: Up to Week 4]
7-Day Physical Activity Recall [Срок оценки: Baseline, Week 2, Week 4]
Overall Anxiety Severity and Impairment Scale (OASIS) [Срок оценки: Baseline, Week 2, Week 4]
Anxiety Sensitivity Index (ASI-3) Score [Срок оценки: Baseline, Week 2, Week 4]
Quick Inventory of Depressive Symptomatology (QIDS) Score [Срок оценки: Baseline, Week 2, Week 4]
Perceived Stress Scale (PSS) Score [Срок оценки: Baseline, Week 2, Week 4]
Childhood Trauma Questionnaire [Срок оценки: Baseline, Week 2, Week 4]
Insomnia Severity Index (ISI) Score [Срок оценки: Baseline, Week 2, Week 4]
International Physical Activity Questionnaire (IPAQ) Score [Срок оценки: Baseline, Week 2, Week 4]
Body Mass Index (BMI) [Срок оценки: Baseline, Week 2, Week 4]

Критерии участия

Критерии включения

For both participant groups: To be eligible to participate in this study, an individual must meet all of the following criteria:

Between 18-50 years of age
Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
Capable and willing to provide informed consent

For anxiety disorder participant group, an individual must also meet:

Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder

Критерии исключения

Lifetime history of Bipolar I or II or any psychotic disorder
Bulimia or anorexia in the past 3 months
Alcohol or substance use disorder in the past 3 months
Current major depressive disorder (past is allowed)
Current neurologic disorder
High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with a need for referral to higher level of care
Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety and/or depression (supportive therapy and couples therapy are allowed)
Risk for exercise according to the Physical Activity Readiness Questionnaire with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
Women who are currently pregnant or plan to become pregnant during the duration of the study
current psychiatric medication
Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
Active infection

Non-psychiatric controls who meet the following criteria will be excluded from participation in this study: