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

June 2, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Experimental: 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.
Other: Flyer
Participants will engage in slow, controlled diaphragmatic breathing exercises, box breathing, and arm exercises at home using printed instructions as guide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks
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 weeks
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.
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Canadian Lung Association

Investigators

  • Principal Investigator: Diana C. Sanchez-Ramirez, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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