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Идёт набор NCT07189286

Preserving Ability Through Virtual Exercise (PAVE)

Без фазы С лечением Feasibility Studies

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: PAVE intervention, Education control.
Кому может быть актуально
Состояния в реестре: Feasibility Studies. Базовые параметры: от 55 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 →
Официальное название

Preserving Ability Through Virtual Exercise (PAVE): An Intervention to Increase the Physical Activity of Hospitalized Older Adults

Обзор

Each day in the hospital leads to functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention at helping older adults engage in physical activity and maintain physical function and mental health during their hospital stay. As virtual reality technology becomes more affordable and ubiquitously available across the world, this study will demonstrate how this technology could be leveraged to maintain the function of older adults in the hospital.

Подробное описание

Older adults (≥60 years) experience multi-level barriers to physical activity when hospitalized. Patient level barriers to physical activity when hospitalized include tethers (e.g., foley catheters, intravenous infusions), symptoms of their acute illness (e.g., pain, fatigue), low self-efficacy to perform physical activity, and a perception that they should remain on bedrest when hospitalized. Interpersonal barriers to physical activity, highlighted during this post pandemic environment, include staffing shortages and increased patient acuity, which can force nurses to prioritize other critical tasks over the physical activity of their patients. Environmental barriers to physical activity include bed alarms and a hospital climate that is hyper focused on the incorrect assumption that physical activity increases fall risk among hospitalized older adults.

This lack of physical activity in the hospital generates major personal and societal costs. Each day a patient spends in the hospital increases their risk of functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. Hospital associated deconditioning increases the length of hospital stays, and increases the susceptibility of patients to delirium, falls, and re-admission. Such complications ultimately increase health care costs. Therefore, there is a significant unmet need to identify strategies to increase older patients' physical activity while minimizing staff burden.

The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention to engage older adults in physical activity and maintain physical function and mental health during their hospital stay. This quasi-experimental study has two aims.

Primary) Aim 1: Using the NIH Behavior Change consortium guidelines, the Acceptability/Appropriateness of Intervention Measure, the Simulator Sickness Questionnaire, and semi-structured individual interviews, determine the feasibility of a virtual reality intervention among hospitalized older adults.

Aim 2: Test the preliminary efficacy of the PAVE intervention on 1) time spent in physical activity during the hospital stay, 2) maintenance of physical function, and 3) maintenance of mental health, compared to the education only control group.

Hypothesis 2.1. Patients exposed to the PAVE intervention will demonstrate more time spent in physical activity (MotionWatch, Modified Physical Activity Vital Sign) during their hospital stay, when compared to those exposed to the education control, controlling for appropriate covariates.

Hypothesis 2.2. Patients exposed to the PAVE intervention will better maintain their physical function throughout their hospital stay (Barthel Index, UMove), when compared to those exposed to the education control, controlling for appropriate covariates.

Hypothesis 2.3. Patients exposed to the PAVE intervention will better maintain their mental health throughout their hospital stay (Hospital Anxiety and Depression Scale, Brief Reslience Scale), when compared to those exposed to the education control, controlling for appropriate covariates.

Вмешательства

  • Поведенческое PAVE intervention
    The commercial virtual reality app that will be used for the intervention, Supernatural, provides participants a trainer as they use their arms and legs (e.g., seated knee strikes) to smash targets to 500+ musical tracks. In this manner, this study employs fun as a motivator for exercise commencement and adherence while hospitalized. The research assistant will implement the intervention using the three-step approach including: (1) patient mobility screen, (2) orientation to the technology and i
  • Поведенческое Education control
    Education control participants will receive and physical activity education using the NIH "Get Fit for Life" booklet.

Первичные конечные точки

  • Feasibility: Acceptability of Intervention Measure [Срок оценки: measured at discharge or 7 days post baseline, whichever occurs first]
  • Feasibility: Appropriateness of Intervention Measure [Срок оценки: measured at discharge or 7 days post baseline, whichever occurs first]
  • Feasibility: Simulator Sickness Questionnaire [Срок оценки: measured following PAVE participants' first virtual reality session only; baseline only]
  • Feasibility: Qualitative Interviews [Срок оценки: measured at discharge or 7 days post baseline, whichever occurs first (PAVE participants only)]
Вторичные конечные точки (6)
  • Physical Activity [Срок оценки: At baseline enrollment, we will apply the MotionWatch8 to participants' wrists. At discharge, or 7 days after baseline, whichever occurs first, we will remove the MotionWatch8.]
  • Physical Activity: Modified Physical Activity Vital Sign [Срок оценки: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
  • Physical Function: Barthel Index [Срок оценки: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
  • Physical Function: UMove Mobility Screen [Срок оценки: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
  • Mental Health: Hospital Anxiety and Depression Scale [Срок оценки: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
  • Brief Resilience Scale [Срок оценки: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]

Критерии участия

Критерии включения

  • in the last 72 hours, they were admitted to the medical floor that is the setting of the study,
  • are 55 years or older,
  • their bedside nurse approves their physical activity participation in this study

Критерии исключения

  • they are unable to pass the Evaluation to Sign Consent Measure,
  • they score 20 or lower on the Montreal Cognitive Assessment Basic,
  • they have an admitting diagnosis that could be worsened through virtual reality exercise,
  • they have an attached medical device that decreases the safety of physical activity such as a nasogastric tube or continuous fluids running through a PICC line that cannot be paused,
  • they are unable to follow commands or move their extremities against gravity during the UMove Mobility Assessment,
  • they are unable to wear the virtual reality headset,
  • they received the education control intervention or PAVE intervention during a prior admission,
  • there is an active plan to discharge this patient during day of recruitment or the following day,
  • they are on airborne or droplet precautions

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • UMMC Midtown Campus — Baltimore

Идентификаторы

NCT: NCT07189286 · 1K01AG090761-01A1 · 1K01AG090761-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗