Меню
Набор скоро начнётся NCT07628725

VR-Assisted Exercise for Symptom Management and Rehabilitation in Interstitial Lung Disease

Без фазы С лечением Interstitial Lung Disease (ILD)

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: Flyer, VR-based.
Кому может быть актуально
Состояния в реестре: Interstitial Lung Disease (ILD). Базовые параметры: от 18 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 →
Официальное название

Virtual Reality-Assisted Breathing Exercises to Support Symptom Management and Rehabilitation in Interstitial Lung Diseases

Обзор

This project aims to create and improve a VR-based breathing exercise program for patients with interstitial lung diseases (ILDs). It involves three phases: (1) developing an interactive VR application with guided breathing exercises and real-time biofeedback tailored for ILD patients, (2) testing its feasibility by evaluating usability and acceptability, and (3) refining the intervention based on feedback from the feasibility study.

Подробное описание

The study is structured into three phases. Phase 1 involves the development of a VR application co-designed by an interprofessional team, including rehabilitation researchers, a biomedical engineer, and a patient partner. The application will deliver guided breathing exercises with real-time biofeedback, specifically tailored to the needs and limitations of individuals with ILDs.

Phase 2 evaluates the feasibility of the intervention. A total of 32 adult participants diagnosed with fibrotic ILDs will be recruited. Inclusion criteria are: (a) age ≥18 years, (b) ability to understand English, and (c) a confirmed diagnosis of fibrotic ILDs. Exclusion criteria include: (a) recent acute exacerbation or hospitalization, (b) inability to provide informed consent (e.g., due to cognitive impairment), and (c) conditions that prevent safe use of VR, such as significant visual or auditory impairments.

At the intake visit in the Respirability Lab, an RA will obtain informed consent, explain the study procedures, and conduct a practice session based on the participant's assigned group. Participants will also receive individualized safety parameters, including target heart rate limits, minimum oxygen saturation thresholds, and training on the use of a pulse oximeter and associated mobile application.

The study uses a randomized crossover design, where each participant completes both the VR intervention and the control condition in a randomized order, separated by a 2-week washout period.

The intervention group will use the VR-based breathing application at home for approximately 10 minutes per day, five days per week, over a 4-week period. The program includes a gradual transition from supervised to independent use to ensure safety and correct technique wherein in week 1, participants complete two supervised laboratory sessions and three home sessions; Weeks 2-4 are primarily home-based, with one additional lab session in Week 3 for reinforcement and monitoring.

The control group performs exercises at home using printed instructions. The frequency and duration match the intervention group.

Throughout both conditions, participants will use a finger pulse oximeter (Wellue O2Ring Smart) to monitor oxygen saturation and heart rate during sessions. After each exercise session, participants will be asked to open apps on their smartphone or tablet linked to the wearable devices via Bluetooth so that the data can be transmitted to the research team or emailed to the RA (CVS format).They will also receive weekly follow-up calls from the research team and have access to support from the RA for any questions or concerns.

Вмешательства

  • Другое Flyer
    Participants will engage in slow, controlled diaphragmatic breathing exercises, box breathing, and arm exercises at home using printed instructions as guide.
  • Другое VR-based
    Participants will engage in guided breathing exercises and arm exercises delivered through an immersive VR application. The intervention will be performed while seated comfortably and will follow a progressive training schedule consisting of supervised laboratory sessions and independent home-based sessions.

Первичные конечные точки

  • Change in Dyspnea [Срок оценки: 4 weeks]
  • Fatigue Severity Scale [Срок оценки: 4 weeks]
  • 1-minute sit-to-stand [Срок оценки: 4 weeks]
  • Change in Health Related Quality of Life [Срок оценки: 4 weeks]
  • 6-minute walk test [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • ≥ 18 years old
  • able to understand English
  • diagnosed with Interstitial Lung Disease (ILD)

Критерии исключения

  • experiencing acute exacerbation of their condition
  • being unable to provide informed consent
  • being unable to participate in a VR-based intervention

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07628725 · 5014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗