Идёт набор NCT04922762

Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2

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: Moderate Intensity, Normal Volume Exercise Training, High Intensity, Normal Volume Exercise Training, Moderate Intensity, High Volume Exercise Training.
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 #2 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 three treadmill running programs that differ by exercise intensity and/or exercise frequency.

Вмешательства

Поведенческое Moderate Intensity, Normal Volume Exercise Training
Week 1 3 days/week for 20 minutes/day Performed at 70% of heart rate maximum Week 2 3 days/week for 30 minutes/day Performed at 70% of heart rate maximum Weeks 3-10 3 days/week for 45 minutes/day Performed at 70% of heart rate maximum
Поведенческое High Intensity, Normal Volume Exercise Training
Week 1 3 days/week for 31 minutes/day 10 minute warm up at 50% of heart rate maximum 2 x 4 minute intervals 4 minutes at 90-95% of heart rate maximum 3 minutes at 70% of heart rate maximum REPEAT 7 minute cool down at 50% of heart rate maximum Week 2 3 days/week for 38 minutes/day 10 minute warm up at 50% of heart rate maximum 3 x 4 minute intervals 4 minutes at 90-95% of heart rate maximum 3 minutes at 70% of heart rate maximum REPEAT 2 TIMES 7minute cool down at 50% of heart rate maximum Wee
Поведенческое Moderate Intensity, High Volume Exercise Training
Week 1 5 days/week for 20 minutes/day Performed at 70% of heart rate maximum Week 2 5 days/week for 30 minutes/day Performed at 70% of heart rate maximum Weeks 3-10 5 days/week for 45 minutes/day Performed at 70% of heart rate maximum

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