NCT07628725

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

June 5, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 27, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

Interstitial Lung DiseaseTelerehabilitationVR-based

Outcome Measures

Primary Outcomes (5)

  • Change in Dyspnea

    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

    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

    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

    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

    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

Study Arms (2)

VR-based Breathing Exercise

EXPERIMENTAL

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

Breathing Exercises using Printed Materials

EXPERIMENTAL

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

Interventions

FlyerOTHER

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

Breathing Exercises using Printed Materials

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.

VR-based Breathing Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Diana C. Sanchez-Ramirez

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana C. Sanchez-Ramirez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study is a randomized crossover factorial trial involving 32 participants with ILDs. All participants will complete both the VR breathing exercise intervention and the breathing exercise program using a printed material, but in a randomized order separated by a 2-week washout period to minimize carryover effects.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 5, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

June 5, 2026

Record last verified: 2026-05