Идёт набор NCT04916327

Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1

Без фазы С лечением Peripheral Vascular Diseases

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: Antioxidant, Placebo.
Кому может быть актуально: Состояния в реестре: Peripheral Vascular Diseases. Базовые параметры: 18 лет — 35 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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Обзор

The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Подробное описание

Study #1 is made up of three sessions done on three separate days and the entire study can be completed in as little as two weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting \< 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2.

Вмешательства

Пищевая добавка Antioxidant
Subjects will ingest an antioxidant cocktail containing 800 milligrams of alpha lipoic acid, 1 gram of vitamin C (ascorbic acid), and 400 milligrams of vitamin E (alpha tocopherol).
Пищевая добавка Placebo
Subjects will ingest placebo (microcrystalline cellulose) pills.

Первичные конечные точки

Arm Vascular Function at Rest (Flow Mediated Dilation Test) [Срок оценки: Baseline to the end of the final visit, about 2 weeks]
Leg Vascular Function (Passive Leg Movement Test) [Срок оценки: Baseline to the end of the final visit, about 2 weeks]
Arm Vascular Function in Response to Exercise (Handgrip Exercise Test) [Срок оценки: Baseline to the end of the final visit, about 2 weeks]

Критерии участия

Критерии включения

apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
for PTSD group, a score of ≥ 33 on PCL-5 checklist
for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist
for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist