Меню
Идёт набор NCT04756245

The VESPA Pilot Study

Без фазы С лечением Exercise Behavior Loneliness Social Isolation

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, Video Conference.
Кому может быть актуально
Состояния в реестре: Exercise, Behavior, Loneliness, Social Isolation. Базовые параметры: 45 лет — 80 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Virtually Engaging Socially With Physical Activity (VESPA) Pilot Study

Обзор

Physical activity has been described by the US federal government as a 'best buy' for public health. Unfortunately, most adults in the United States are not sufficiently active, and this worsens with age. Low levels of participation are driven by many challenging barriers, including lack of access, few opportunities for enjoyable activity, and few supportive social relationships, which is especially important given the central role of social connection for lasting behavior change. A half-century of research in behavioral sciences has generated effective group-based physical activity programs, but these are inaccessible to most as they are often delivered in a few select research centers. Recent advances in telehealth have offered media for extending these interventions more broadly, but the experience of such programs is often hampered by technology that does not allow for a sense of physical and social presence. Fortunately, uptake of virtual reality (VR) is increasing rapidly, and the medium has a high level of potential for advancing the delivery of immersive evidence-based group interventions to those that most need it. Thus our specific aims are: Specific aim 1: To test the feasibility and acceptability of a group-mediated physical activity intervention delivered fully via modern VR to older adults. Specific aim 2: To examine the impact of this program on overall physical activity among older adults compared to the current standard-of-care for telehealth: the video conference meeting platform.

Вмешательства

  • Поведенческое Virtual Reality
    Participants in this arm participate in 4 group-based behavioral counseling sessions plus 8 one-on-one coaching session within virtual reality software. Participants aim to engage in approximately 150 minutes per week of moderate-to-vigorous activity, with options including both virtual reality and real-world physical activities.
  • Поведенческое Video Conference
    Participants in this arm participate in 4 group-based behavioral counseling sessions plus 8 one-on-one coaching session within video conference software. Participants aim to engage in approximately 150 minutes per week of moderate-to-vigorous activity, with options including both streaming video and real-world physical activities.

Первичные конечные точки

  • The percentage of individuals attending all one-on-one and group calls [Срок оценки: Weeks 0 through 4]
  • Acceptability [Срок оценки: Baseline]
Вторичные конечные точки (2)
  • Physical Activity [Срок оценки: Baseline, Week 4]
  • Social Relatedness [Срок оценки: Baseline, Week 4]

Критерии участия

Критерии включения

  • Age of 45-80 years
  • Body mass index between 30-45 kg/m2
  • Low-active (30 or more minutes of moderate intensity physical activity on 2 or fewer days per week)
  • Have access to home Wi-Fi
  • Have regular access to a computer, tablet, or smartphone to receive teleconferencing calls
  • Have a clear "VR space" (7'x7' object-free space)
  • Have an "Activity buddy" (spouse, child, caregiver, etc.)
  • Modified Telephone Interview for Cognitive Status (TICS-M) score of 32 or greater
  • Consent from a physician for study participation
  • Proficient in the English language
  • Willingness to create or use existing personal Facebook account for virtual reality activities.

Критерии исключения

  • Current involvement in other physical activity research studies
  • Hearing or sight impairments (significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation, colorblindness)
  • Dependence on a cane or walker
  • More than 1 fall in the past year
  • Contraindication to exercise
  • Current or recent history within the last 6 months of: symptomatic coronary heart disease, cancer, liver or renal disease, severe pulmonary disease, gross physical impairment, or uncontrolled hypertension; myocardial infarction or cardiovascular procedure within the last 3 months
  • History of or diagnosis of photosensitive epilepsy
  • Score of "severe" on any question in the Virtual Reality Sickness Questionnaire;
  • Unwillingness to use a head-mounted virtual reality system
  • Current severe or untreated depression

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
Профилактика

Центры проведения

США · 1 центр
  • Wake Forest University — Winston-Salem

Публикации

  • Kershner K, Morton D, Robison J, N'dah KW, Fanning J. Assessing the Feasibility and Acceptability of Virtual Reality for Remote Group-Mediated Physical Activity in Older Adults: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Nov 8;8:e53156. doi: 10.2196/53156. PMID 39514256

Идентификаторы

NCT: NCT04756245 · 00023881

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗