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Набор скоро начнётся NCT06556784

Immersive Virtual Reality Exergames and Office Workers' Cardiometabolic Health

Без фазы С лечением Exergaming Metabolic Syndrome

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: 12-week at-home immersive virtual reality exergame.
Кому может быть актуально
Состояния в реестре: Exergaming, Metabolic Syndrome. Базовые параметры: 18 лет — 64 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
Список центров уточняется — проверьте первичный протокол.
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

At-home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial

Обзор

The worldwide increasing of prevalence of non-communicable diseases has grown the recognition of necessity for identifying the modifiable risk in preventing and managing these diseases. While, the office worker, as a representative group of physical inactivity, is exposed to risk factor of metabolic syndrome which is considered as the pathway of non-communicable diseases. This study mainly focuses on the purpose of examining the interventional efficacy of at-home immersive virtual reality exergame on several metabolic syndrome biomarkers among office workers. In addition, it purposes to determine the impacts of at-home immersive virtual reality exergame on lifestyle pattern of office workers. A 2-armed, single blinded randomized controlled trial (RCT) will be applied to examine the therapeutic effects of at-home immersive virtual reality exergame in this exploratory study. 120 Japanese office workers with less than 150 minutes per week of moderate to vigorous sports activities will be recruited by a convenience sample method. They are randomly allocated to two parallel groups, which including an intervention group: 12-week training of at least 150 minutes per week at-home immersive virtual reality exergame playing with a set device of Meta Quest 2, a control group: 12-week of maintaining regular exercise, eating, and working habits without making significant changes. During this 12-week trial, 3 main follow up steps are included at the timelines of 0 week, 6 weeks, 12 weeks. For each follow up, we will collect three types of variables, including major clinical risk factors of metabolic syndrome, lifestyle pattern factors of metabolic syndrome, and demographics (0 week only). To analysis the variance between intervention group and control group, mixed linear model will be applied to understand the efficacy result of this intervention. The variances of metabolic syndrome clinical risk factors between groups would be used to express the therapeutic effects of at-home immersive virtual reality exergame. The changes of lifestyle pattern factors would be applied to show the impacts of at-home immersive virtual reality exergame on lifestyle pattern.

Вмешательства

  • Поведенческое 12-week at-home immersive virtual reality exergame
    12-week training of at least 150 minutes per week at-home immersive virtual reality exergame playing with a set device of Meta Quest 2 and maintaining regular eating and working habits without making significant changes.

Первичные конечные точки

  • High-density lipoprotein cholesterol (HDL-C) [Срок оценки: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).]
  • Low-density lipoprotein cholesterol (LDL-C) [Срок оценки: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).]
  • Impaired fasting glucose [Срок оценки: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).]
  • Triglycerides [Срок оценки: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).]
  • Hypertension [Срок оценки: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).]
  • Body mass index [Срок оценки: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).]
Вторичные конечные точки (2)
  • Exercise time (including exergaming time) [Срок оценки: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).]
  • Sedentary time [Срок оценки: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).]

Критерии участия

Критерии включения

  • 18-64 years old
  • Capable of standing and exercising.
  • Having no history of diagnosis of heart disease, cancer, or dementia.
  • Being interested in playing with the exergames.
  • Willingness of adhering to a 12-week interventional exergame treatment.

Критерии исключения

  • Individuals who are already engaged in more than 150 minutes per week of moderate to vigorous activities.
  • Individuals with some pharmacological treatments, some surgery (bariatric surgery), and some traditional Chinese medicine.

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
Тройное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Zhao J, Yasunaga A, Kaczynski AT, Park H, Luo Y, Li J, Shibata A, Ishii K, Yano S, Oka K, Koohsari MJ. At-Home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 20;14:e64560. doi: 10.2196/64560. PMID 39832174

Идентификаторы

NCT: NCT06556784 · VRGOWH2024Z

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗