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Идёт набор NCT05563805

Exploring Virtual Reality Adventure Training Exergaming

Без фазы С лечением Physical Activity Sedentary Behavior Depression Cognitive Function

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: Virtual Reality-based physical activity intervention.
Кому может быть актуально
Состояния в реестре: Physical Activity, Sedentary Behavior, Depression, Cognitive Function. Базовые параметры: 18 лет — 45 лет · Женщины.
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 →
Официальное название

Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Veterans' Health Outcomes

Обзор

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.

Подробное описание

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed. The project addresses two specific aims:

Aim 1. To examine the effects of an 8-week V-RATE intervention on physical health (i.e., BMI, physical activity, sedentary behavior) among veterans. We hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the V-RATE group would exhibit more improvement in the physical health indicators after the intervention compared to individuals in the control group. We further hypothesize gains would be maintained or enhanced at 1-month follow-up measure.

Aim 2. To examine the effects of an 8-week V-RATE intervention on mental health outcomes (i.e., depression, anxiety, posttraumatic stress, cognitive function, health-related quality of life), among veterans. We hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the V-RATE group will exhibit more improvement in the mental health indicators after the intervention compared to individuals in the control group. We further hypothesize gains maintained or enhanced at 1-month follow-up measure.

Вмешательства

  • Устройство Virtual Reality-based physical activity intervention
    The V-RATE intervention will be delivered through a 360-degree non-mobilized treadmill in a university clinical laboratory for 6-8-weeks (1-2 days/week, 30 minutes/session) totaling 6 sessions. The V-RATE program will be focused on creating a safe and immersive environment supportive of physical activity. The treadmill enables an individual can walk and run at self-paced speed, moving in 360-degrees (i.e., forwards, sideways, and backwards) without risk of falling. The core feature of the self-p

Первичные конечные точки

  • Change in depression from baseline to week 6-8 and one-month follow-up (Week 12) [Срок оценки: Baseline, Week 6-8, Week 12]
Вторичные конечные точки (7)
  • Anxiety change from baseline to week 6-8 and one-month follow-up (Week 12) [Срок оценки: Baseline, post-training, Week 12]
  • Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12) [Срок оценки: Baseline, post-training, Week 12]
  • Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12) [Срок оценки: Baseline, post-training, Week 12]
  • Health-Related Quality of Life (HRQOL) change from baseline to week 8 and one-month follow-up (Week 12) [Срок оценки: Baseline, Week 6-8, Week 24]
  • BMI change from baseline to week 6-8 and one-month follow-up (Week 12) [Срок оценки: Baseline, post-training, Week 12]
  • Physical Activity and Sedentary Behavior change from baseline to week 8 and one-month follow-up (Week 12) [Срок оценки: Baseline, Week 8, Week 24]
  • Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (Week 12) [Срок оценки: Baseline, post-training, Week 12]

Критерии участия

Критерии включения

  • Are between the ages of 18 and 45
  • Identify as a U.S. military veteran

4\. Normal vision (no colorblindness)

Критерии исключения

  • Unable to walk independently (e.g., use of any mobility assistive device such as brace, wheelchair, cane, crutch, walker, knee scooter)
  • Self-reported joint problem that limits mobility (e.g., arthritis or other condition that would prevent participation) or ongoing orthopedic injury
  • Self-reported pregnancy or suspicion of pregnancy
  • Self-reported motor disorder or impaired sense of motion or balance (such as Parkinsonism)
  • Self-reported color blindness
  • Self-reported neurological or cognitive disorder (e.g., TBI, history of seizure)
  • Self-reported cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Texas at Arlington — Arlington

Идентификаторы

NCT: NCT05563805 · UTexasArlington

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗