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NCT Number: NCT07628725

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

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.

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Key information

Conditions

Interstitial Lung Disease (ILD) Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flyer

Other

Participants will engage in slow, controlled diaphragmatic breathing exercises, box breathing, and arm exercises at home using printed instructions as guide.

VR-based

Other

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.

Primary outcomes

  1. Change in Dyspnea

    Time frame: 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.

  2. Fatigue Severity Scale

    Time frame: 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.

  3. 1-minute sit-to-stand

    Time frame: 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. Change in Health Related Quality of Life

    Time frame: 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.

  5. 6-minute walk test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana C. Sanchez-Ramirez, PhD

CONTACT

[email protected]

120-448-01346

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Lung Association

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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