VR-Assisted Exercise for Symptom Management and Rehabilitation in Interstitial Lung Disease
Virtual Reality-Assisted Breathing Exercises to Support Symptom Management and Rehabilitation in Interstitial Lung Diseases
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Diana C. Sanchez-Ramirez, PhD
- 電話番号：120-448-01346
- メール：diana.sanchez-ramirez@umanitoba.ca
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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実験的：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.
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Participants will engage in slow, controlled diaphragmatic breathing exercises, box breathing, and arm exercises at home using printed instructions as guide.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Dyspnea
時間枠：4 weeks
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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.
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4 weeks
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Fatigue Severity Scale
時間枠：4 weeks
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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.
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4 weeks
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1-minute sit-to-stand
時間枠：4 weeks
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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.
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4 weeks
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Change in Health Related Quality of Life
時間枠：4 weeks
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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.
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4 weeks
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6-minute walk test
時間枠：4 weeks
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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.
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4 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Diana C. Sanchez-Ramirez、University of Manitoba
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。