Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3
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: Muscular Strength Training Group, Muscular Fitness Training Group.
- 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 effect of various forms of exercise training on 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 #3 is made up of five sessions done on five separate days and the entire study can be completed in as little as 14 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. also include two additional testing days (Visits 5 and 6) that are identical to Visits #2 and #3, two visits to test endurance or strength prior to and after the exercise training (Visit 4 and 7), and ten weeks of exercise training (done 3-5 days per week). The exercise training will include one of two weight lifting programs that differ based on the amount of weight lifted (heavy vs moderate weight).
Вмешательства
- Поведенческое Muscular Strength Training Group
Week 1 3 days/week Bench Press - 1 set at 80% of one repetition maximum (1RM) Bent Over Row - 1 set at 80% 1RM Back Squat - 1 set at 80% 1RM Romanian Deadlift - 1 set at 80% 1RM Week 2 3 days/week Bench Press - 2 sets at 80% 1RM Bent Over Row - 2 sets at 80% 1RM Back Squat - 2 sets at 80% 1RM Romanian Deadlift - 2 sets at 80% 1RM Weeks 3-10 3 days/week Bench Press - 3 sets at 80% 1RM Bent Over Row - 3 sets at 80% 1RM Back Squat - 3 sets at 80% 1RM Romanian Deadlift - 3 sets at 80% 1RM - Поведенческое Muscular Fitness Training Group
Week 1 3 days/week Bench Press - 1 set at 65% 1RM Bent Over Row - 1 set at 65% 1RM Back Squat - 1 set at 65% 1RM Romanian Deadlift - 1 set at 65% 1RM Week 2 3 days/week Bench Press - 2 sets at 65% 1RM Bent Over Row - 2 sets at 65% 1RM Back Squat - 2 sets at 65% 1RM Romanian Deadlift - 2 sets at 65% 1RM Weeks 3-10 3 days/week Bench Press - 3 sets at 65% 1RM Bent Over Row - 3 sets at 65% 1RM Back Squat - 3 sets at 65% 1RM Romanian Deadlift - 3 sets at 65% 1RM
Первичные конечные точки
- Arm Vascular Function at Rest (Flow Mediated Dilation Test) [Срок оценки: Baseline to the end of the final visit, about 14 weeks]
- Leg Vascular Function (Passive Leg Movement Test) [Срок оценки: Baseline to the end of the final visit, about 14 weeks]
- Arm Vascular Function in Response to Exercise (Handgrip Exercise Test) [Срок оценки: Baseline to the end of the final visit, about 14 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
Критерии исключения
- taking medications that could influence cardiovascular function
- current smokers who have recently quit smoking
- illicit drug use or excessive alcohol consumption
- pregnant women
- significant calorie restriction or vitamin/mineral deficiencies
- limited English proficiency
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- Virginia Commonwealth University — Richmond
Идентификаторы
NCT: NCT04916340 · HM20020955-3