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

2026년 6월 2일 업데이트: Diana C Sanchez-Ramirez, PhD, University of Manitoba

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

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.

연구 개요

상태

아직 모집하지 않음

상세 설명

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.

연구 유형

중재적

등록 (추정된)

32

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

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

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: VR-based Breathing Exercise
Participants in the intervention group will perform VR-guided breathing exercises at home for approximately 10 minutes per day, five days a week, for four weeks. These exercises include DDBE, box breathing, and arm training. The training will gradually transition from supervised laboratory sessions to independent home use to ensure the safe and proper use of the VR system and wearable devices.
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.
실험적: Breathing Exercises using Printed Materials
Participants will perform breathing exercises and arm exercises at home using a printed instructional flyer. The frequency and duration of exercises will match the VR intervention group at approximately 10 minutes per day, five days per week, over 4 weeks.
Participants will engage in slow, controlled diaphragmatic breathing exercises, box breathing, and arm exercises at home using printed instructions as guide.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Dyspnea
기간: 4 weeks
The Medical Research Council scale is a five-point grading system (1 to 5) used to classify the degree of activity limitation caused by dyspnea, wherein a grade 1 represents the lowest level of breathlessness and a grade 5 represents the highest level of breathlessness and activity limitation.
4 weeks
Fatigue Severity Scale
기간: 4 weeks
Measures the severity of fatigue and its effects on a person's activities and lifestyle in patients with a variety of disorders using a 9-item questionnaire that measures how fatigue affects daily activities. Each item is rated on a 7-point scale wherein a score of 1 means strongly disagree, while a score of 7 means strongly agree. This means that a lower scores indicate less fatigue and a higher scores indicate more severe fatigue.
4 weeks
1-minute sit-to-stand
기간: 4 weeks
The 1-Minute Sit-to-Stand Test is used to evaluate exercise tolerance in patients with chronic respiratory diseases. It measures lower-limb strength, endurance, and cardiorespiratory fitness by counting the repetitions of sit-to-stand completed within 60 seconds.
4 weeks
Change in Health Related Quality of Life
기간: 4 weeks
Assessed using the St George's Respiratory Questionnaire which is a standardized questionnaire for measuring impaired health and perceived well-being ("quality of life") in airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
4 weeks
6-minute walk test
기간: 4 weeks
The 6-minute walk test assesses the sub-maximal level of functional capacity by measuring the distance that the patient can walk quickly on a flat, hard surface in a period of 6 minutes.
4 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Diana C. Sanchez-Ramirez, University of Manitoba

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2026년 12월 15일

연구 완료 (추정된)

2026년 12월 15일

연구 등록 날짜

최초 제출

2026년 5월 27일

QC 기준을 충족하는 최초 제출

2026년 6월 2일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 5014

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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