Interstitial Lung DiseaseNCT07167238
The Effect of Video Game-Based Exercise Training in Patients With Interstitial Lung Disease
A study testing Virtual reality exercises and Home exercises in people with Interstitial Lung Disease, run by Istinye University.
Trial summary
The goal of this prospective randomized controlled clinical trial is to evaluate the effects of video game-based physiotherapy and rehabilitation on functional exercise capacity and respiratory parameters in individuals with interstitial lung disease (ILD). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Virtual reality exercises and Home exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2026to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with mild to moderate interstitial lung disease
- Being between the ages of 20 and 70
- Being referred to the study by their physician
- Being willing and able to participate
- Having no physical or cognitive disability that would prevent them from participating in exercise training
Who cannot join
- Presence of cardiovascular disease (acute heart failure, unstable angina, or recent myocardial infarction, etc.)
- Presence of cognitive impairment that prevents participation in exercise training
- Presence of a history of cerebrovascular accident
- Presence of a history of cancer
About this study
Official title: An Evaluation of the Effect of Video Game-Based Exercise Training on Functional Exercise Capacity and Respiratory Parameters in Patients With Interstitial Lung Disease
The goal of this prospective randomized controlled clinical trial is to evaluate the effects of video game-based physiotherapy and rehabilitation on functional exercise capacity and respiratory parameters in individuals with interstitial lung disease (ILD). The study also aims to compare the outcomes of video game-based rehabilitation with conventional physiotherapy, identify alternative breathing exercises for pulmonary involvement in ILD, and provide scientific evidence to guide clinical practice.
The main questions it aims to answer are:
Read more
Does video game-based rehabilitation improve respiratory function parameters in individuals with ILD?
Does video game-based rehabilitation reduce dyspnea and exercise intolerance, thereby improving functional exercise capacity?
Does video game-based rehabilitation increase participation and completion rates in pulmonary rehabilitation programs? Study Design: A total of 42 participants diagnosed with mild-to-moderate ILD will be recruited. Participants will be randomized into two groups (21 in the intervention group, 21 in the control group) using stratified randomization to ensure homogeneity by age, sex, and ILD type.
Arms: 2 (Intervention group and Control group)
Intervention:
Intervention group: Structured video game-based exercise training sessions as part of a pulmonary rehabilitation program.
Control group: Conventional pulmonary rehabilitation program.
Assessments: Respiratory function, functional exercise capacity, and symptom levels will be measured before and after the intervention.
Inclusion criteria:
Diagnosis of mild-to-moderate ILD
Aged 20-70 years
Referral by a treating physician
Willingness and ability to participate
No physical or cognitive barriers to exercise training
Exclusion criteria:
Cardiovascular disease (e.g., acute heart failure, unstable angina, recent myocardial infarction)
Cognitive impairment
History of cerebrovascular event
History of cancer
Withdrawal criteria:
Development of clinical hemodynamic instability
Major surgical complication during the study
Missing ≥ 3 consecutive training sessions in the intervention group
Withdrawal of consent
Read the detailed description
Interstitial lung diseases (ILDs) are chronic parenchymal disorders characterized by varying degrees of inflammation and fibrosis, leading to exertional dyspnea, exercise intolerance, ventilatory restriction, and reduced health-related quality of life. Beyond pulmonary involvement, patients often experience fatigue, peripheral muscle weakness, anxiety, and reduced participation in daily activities. Pulmonary rehabilitation is a key non-pharmacological strategy for ILD; however, adherence and completion rates remain limited due to barriers such as symptom burden, transportation, and the repetitive nature of conventional exercise training.
Technology-assisted rehabilitation, particularly video game-based training (exergaming), has emerged as a promising strategy to enhance motivation and adherence while preserving the physiological benefits of exercise. Exergaming provides real-time feedback, goal-oriented tasks, and progressive challenges that may improve enjoyment, engagement, and consistency of participation. In respiratory rehabilitation, game-guided breathing exercises may reinforce techniques such as pursed-lip breathing, diaphragmatic breathing, and thoracic expansion, which optimize ventilatory mechanics and potentially reduce dyspnea. Additionally, whole-body functional games can promote aerobic capacity, coordination, and peripheral muscle endurance.
This randomized controlled trial is designed to compare the effects of video game-based rehabilitation combined with conventional physiotherapy versus conventional physiotherapy alone in individuals with mild-to-moderate ILD. A total of 42 participants will be randomized into two parallel arms (intervention and control). The intervention arm will receive supervised video game-based exercise sessions in addition to standard pulmonary rehabilitation, while the control arm will perform conventional home-based physiotherapy and rehabilitation only.
Primary outcomes include changes in respiratory function parameters, functional exercise capacity, and symptom perception before and after the 8-week intervention. The study also aims to examine whether video game-based rehabilitation increases adherence and completion rates compared to conventional programs.
The expected impact of this study is to provide scientific evidence regarding the feasibility, safety, and effectiveness of integrating video game-based rehabilitation into pulmonary rehabilitation for ILD. If successful, this approach may help overcome barriers to participation, improve functional outcomes, and support broader implementation of engaging, patient-centered rehabilitation strategies.
- Conditions
- Interstitial Lung Disease
- Being tested
- Virtual reality exercises, Home exercises
- Keywords
- Interstitial lung disease, Video game, Exercise training, Functional exercise capacity, Respiratory parameters
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exercisesBehavioural
Program Duration: 8 weeks Implementation: The conventional program plus supervised video game-based training sessions.
Additional Protocol: Video Game-Based Exercises
- Breathing Labs - Breathing Games (Slovenia) Frequency: 3 days per week, on non-walking days, supervised at the hospital. Structure: 5 mini-games per session, performed sequentially. Exercises: Balloon: Weeks 1-4: Level 1; Weeks 5-8: Level 2. Focus on sustained controlled exhalation. Plane: Weeks 1-4: ~6 sec breath cycle; Weeks 5-8: ~8 sec breath cycle. Wolf: Weeks 1-4: Easy; Weeks 5-8: Medium. Flowers: Weeks 1-4: Sunflower module; Weeks 5-8: Rose module. Pluto: Weeks 1-4: Easy; Weeks 5-8: Medium. Intensity: Target MBS 4-6/10 for dyspnea and fatigue.
- Nintendo Wii / Wii Fit - Functional Training Duration: ~5 minutes per game, 30-40 minutes total per session.
Games and targets:
Lower limb/aerobic: Basic Run, Basic Step, Obstacle Course, Island Cycling. Upper limb: Boxing, Canoe. Balance: Rhythm Parade.
Home exercisesBehavioural
Program Duration: 8 weeks Implementation: Home-based, instructed face-to-face at baseline by a physiotherapist, supported with video materials, and monitored with regular feedback.
- Posture + Breathing Exercises Frequency: 3 sessions per day (morning, noon, evening)
Content:
Shoulder girdle mobilization: Scapular elevation-depression, abduction-adduction (3 sets × 3 repetitions).
Stretching exercises: Shoulder, cervical, and trunk muscles; 5-second hold at end range.
Combined with breathing: Inspiration during concentric phase, expiration during eccentric phase.
- Breathing Exercises Frequency: 3 sessions per day; 10 repetitions of each exercise per session
Content:
Pursed-Lip Breathing, Thoracic Expansion Exercises, Diaphragmatic Breathing, Breathing Control C) Walking Program Frequency: 2 days per week Duration: 30 minutes (5 min warm-up, 20 min walking, 5 min cool-down) Intensity: Self-selected pace targeting Modified Borg Scale (MBS) 4-6/10 for dyspnea.
| Study group | Role | What they receive |
|---|---|---|
| Video game-based exercise training | Experimental | In addition to the unsupervised conventional pulmonary rehabilitation program, they will participate in a supervised video game-based exercise protocol twice a week.
The conventional physiotherapy and rehabilitation program will include posture exercises combined with breathing exercises three times a day, every weekday, and a walking program twice a week, along with breathing exercises. The supervised video game-based exercise program will include five different five-minute breathing labs and breathing games, two days a week, and 40 minutes of Nintendo Wii Fit games, which include lower extremity, upper extremity, and balance exercises. Receives: Behavioral: Virtual reality exercises |
| Conventional Pulmonary Rehabilitation | Active comparator | Only the unsupervised conventional pulmonary rehabilitation (PR) program will be applied on this group. The conventional PR program will include posture exercises combined with breathing exercises three times a day, every weekday, and a walking program twice a week, along with breathing exercises
Conventional PR program including:
Breathing exercises (pursed-lip breathing, thoracic expansion, diaphragmatic breathing, breathing control) Postural exercises combined with breathing Walking program (30 min, 2×/week at Borg scale 4-6) Receives: Behavioral: Home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
FVC will be measured using a spirometry test. During the assessment, participants will be instructed to take a full breath, and with a nose clip in place, exhale into the spirometer with maximum effort. The procedure will be repeated at least three times, and the best value will be recorded. Results will be expressed in liters (L) and compared to predicted values based on age, height, sex, and ethnicity. A value of ≥80% of the predicted capacity will be considered normal.
Measured: Day 1 and at the end of the eighth week
Forced Expiratory Volume in 1 Second (FEV₁)
FEV₁ is defined as the volume of air that will be exhaled during the first second of a forced expiration after a full inspiration. It will be measured by spirometry and expressed in liters (L). Results will be compared to predicted values calculated according to age, height, sex, and ethnicity. A value of ≥80% of the predicted capacity will be considered normal.
Measured: Day 1 and at the end of the eighth week
FEV₁/FVC
The FEV₁/FVC ratio is defined as the proportion of the forced expiratory volume in the first second (FEV₁) to the forced vital capacity (FVC). It will be measured by spirometry. Results will be expressed as a percentage and compared to predicted values according to age, height, sex, and ethnicity. A value of ≥70% will be considered normal, while lower values will indicate airflow limitation.
Measured: Day 1 and at the end of the eighth week
Peak Expiratory Flow (PEF)
Peak Expiratory Flow (PEF) is defined as the maximum flow rate that will be achieved during a forced expiration after a full inspiration. It will be measured by spirometry and expressed in liters per second (L/s). The procedure will be repeated at least three times, and the best value will be recorded. Results will be compared to predicted values calculated according to age, height, sex, and ethnicity. A value of ≥80% of the predicted capacity will be considered normal.
Measured: Day 1 and at the end of the eighth week
Lung Diffusion Capacity
Diffusing capacity (DLCO) measurement will be performed with the nose closed after the patient has not exercised before the test and has been sitting for at least 5 minutes. Care should be taken to ensure rapid inspiration. Inspiration time should be kept between 2 and 4 seconds. The final expiration should not exceed 4 seconds. Breath-hold times will be measured for all patients as recommended by the European Respiratory Society (ERS) guidelines. Tests with breath-hold times outside the 9-11 second range, inspirations with inspiratory vital capacity (IVC) below 90% during the DLCO maneuver, and measurements with alveolar ventilation below 10% of total lung capacity will be excluded from the study. DLCO measurements will be performed using gas chromatographs, and the results will be recorded as ml/min/mmHg. Hemoglobin-corrected tests will be used as the basis.
Measured: Day 1 and at the end of the eighth week
Peripheral muscle strength
Peripheral muscle strength will be measured using a portable manual muscle strength measurement device (Hoggan MicroFet2 Handheld Dynamometer) for shoulder abductor and adductor, shoulder flexor, extensor, elbow flexor and extensor, hip flexor, extensor, hip abductor, adductor, knee flexor, and extensor muscles. Grip strength will be measured using a handheld dynamometer (Jamar, Nottinghamshire, UK) in a sitting position, with the elbow flexed at 90 degrees and the wrist in neutral. Measurements will be repeated three times for the right and left sides, and the average of the values will be recorded in Newtons (N).
Measured: Day 1 and at the end of the eighth week
Functional Exercise Capacity
Functional exercise capacity will be assessed with the 6-minute walk test (6MWT). Participants are instructed to walk a 30-meter corridor with the goal of covering the longest possible distance in six minutes. Participants are allowed to stop and rest if necessary but are encouraged to continue walking as soon as possible. Participants' heart rate, blood pressure, peripheral oxygen saturation, self-perceived shortness of breath, and lower extremity muscle fatigue are questioned before and after the test. The distance traveled during the six-minute period is recorded. The 6MWT is a valid and reliable test for interstitial lung disease.
Measured: Day 1 and at the end of the eighth week
Secondary outcomes (6)
Quality of Life score
The quality of life score will be assessed using the St. George Respiratory Questionnaire (SGRQ). The SGRQ is a self-assessment questionnaire specific to airway diseases. It consists of 76 questions in three categories. It examines symptoms, activities, and the impact of the disease on daily life. Each section is scored separately from 0 to 100. A score of 0 indicates no impairment in quality of life, while a score of 100 indicates maximum disability and a poor quality of life. So a higher score means a worse outcome.
Measured: Day 1 and at the end of the eighth week
The Modified Borg Scale Score
This scale will be used to evaluate the dyspnea level of the participants. The Modified Borg Scale is scored between 0 and 10. A score of 0 means no shortness of breath at all, while a score of 10 means it's unbearably severe. In other words, a higher score indicates a worse outcome.
Measured: Day 1 and at the end of the eighth week
Modified Medical Research Council Scale Score
This scale will be used to evaluate the dyspnea level of the participants. Modified Medical Research Council Scale (MMRC) is graded from 0 to 4. As the score increases, shortness of breath becomes more severe and functional limitations increase. In other words, a higher score is associated with a worse outcome.
Measured: Day 1 and at the end of the eighth week
Fatigue status
Fatigue status of patients will be evaluated with the Fatigue Severity Scale (FSS). This scale assesses fatigue severity with nine questions. Each question is scored from 1 (completely disagree) to 7 (completely agree). The FSS score is the average of the nine sections. A higher score indicates increased fatigue severity.
Measured: Day 1 and at the end of the eighth week
Dysfunctional Respiration
Dysfunctional respiratory status of patients will be evaluated with the Nijmegen Questionnaire. The Nijmegen Questionnaire is a questionnaire used to identify dysfunctional breathing patterns and unexplained respiratory symptoms. It consists of 16 items scored from 0 to 4. The total score ranges from 0 to 64. A higher total score indicates dysfunctional breathing.
Measured: Day 1 and at the end of the eighth week
Cognitive Function
Patients' cognitive functions will be assessed using the Montreal Cognitive Assessment Scale (MOCA). This scale includes sections assessing executive functions, attention and concentration, memory, language, abstract thinking, visual-spatial skills, orientation, and calculation. The total score is calculated out of 30. The threshold score is 21. Scores of 20 or lower are considered cognitive dysfunction. Higher scores indicate greater cognitive preservation, while lower scores indicate poorer cognitive function.
Measured: Day 1 and at the end of the eighth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start25 Jan 2026 (estimated)
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Kaçar Akkoç, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167238
- Sponsor's protocol ID
- 2025/353
- Status last verified
- Dec 2025
- First submitted
- 15 Aug 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of Video Game-Based Exercise Training on Functional Exercise Capacity and Respiratory Parameters in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07167238
- Acronym / sponsor ID
- 2025/353
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial lung disease, Video game, Exercise training, Functional exercise capacity, Respiratory parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective randomized controlled clinical trial is to evaluate the effects of video game-based physiotherapy and rehabilitation on functional exercise capacity and respiratory parameters in individuals with interstitial lung disease (ILD). The study also aims to compare the outcomes of video game-based rehabilitation with conventional physiotherapy, identify alternative breathing exercises for pulmonary involvement in ILD, and provide scientific evidence to guide clinical practice.
The main questions it aims to answer are:
Does video game-based rehabilitation improve respiratory function parameters in individuals with ILD?
Does video game-based rehabilitation reduce dyspnea and exercise intolerance, thereby improving functional exercise capacity?
Does video game-based rehabilitation increase participation and completion rates in pulmonary rehabilitation programs? Study Design: A total of 42 participants diagnosed with mild-to-moderate ILD will be recruited. Participants will be randomized into two groups (21 in the intervention group, 21 in the control group) using stratified randomization to ensure homogeneity by age, sex, and ILD type.
Arms: 2 (Intervention group and Control group)
Intervention:
Intervention group: Structured video game-based exercise training sessions as part of a pulmonary rehabilitation program.
Control group: Conventional pulmonary rehabilitation program.
Assessments: Respiratory function, functional exercise capacity, and symptom levels will be measured before and after the intervention.
Inclusion criteria:
Diagnosis of mild-to-moderate ILD
Aged 20-70 years
Referral by a treating physician
Willingness and ability to participate
No physical or cognitive barriers to exercise training
Exclusion criteria:
Cardiovascular disease (e.g., acute heart failure, unstable angina, recent myocardial infarction)
Cognitive impairment
History of cerebrovascular event
History of cancer
Withdrawal criteria:
Development of clinical hemodynamic instability
Major surgical complication during the study
Missing ≥ 3 consecutive training sessions in the intervention group
Withdrawal of consent
Detailed description
Interstitial lung diseases (ILDs) are chronic parenchymal disorders characterized by varying degrees of inflammation and fibrosis, leading to exertional dyspnea, exercise intolerance, ventilatory restriction, and reduced health-related quality of life. Beyond pulmonary involvement, patients often experience fatigue, peripheral muscle weakness, anxiety, and reduced participation in daily activities. Pulmonary rehabilitation is a key non-pharmacological strategy for ILD; however, adherence and completion rates remain limited due to barriers such as symptom burden, transportation, and the repetitive nature of conventional exercise training.
Technology-assisted rehabilitation, particularly video game-based training (exergaming), has emerged as a promising strategy to enhance motivation and adherence while preserving the physiological benefits of exercise. Exergaming provides real-time feedback, goal-oriented tasks, and progressive challenges that may improve enjoyment, engagement, and consistency of participation. In respiratory rehabilitation, game-guided breathing exercises may reinforce techniques such as pursed-lip breathing, diaphragmatic breathing, and thoracic expansion, which optimize ventilatory mechanics and potentially reduce dyspnea. Additionally, whole-body functional games can promote aerobic capacity, coordination, and peripheral muscle endurance.
This randomized controlled trial is designed to compare the effects of video game-based rehabilitation combined with conventional physiotherapy versus conventional physiotherapy alone in individuals with mild-to-moderate ILD. A total of 42 participants will be randomized into two parallel arms (intervention and control). The intervention arm will receive supervised video game-based exercise sessions in addition to standard pulmonary rehabilitation, while the control arm will perform conventional home-based physiotherapy and rehabilitation only.
Primary outcomes include changes in respiratory function parameters, functional exercise capacity, and symptom perception before and after the 8-week intervention. The study also aims to examine whether video game-based rehabilitation increases adherence and completion rates compared to conventional programs.
The expected impact of this study is to provide scientific evidence regarding the feasibility, safety, and effectiveness of integrating video game-based rehabilitation into pulmonary rehabilitation for ILD. If successful, this approach may help overcome barriers to participation, improve functional outcomes, and support broader implementation of engaging, patient-centered rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video game-based exercise training | Experimental | Behavioral: Virtual reality exercisesIn addition to the unsupervised conventional pulmonary rehabilitation program, they will participate in a supervised video game-based exercise protocol twice a week. The conventional physiotherapy and rehabilitation program will include posture exercises combined with breathing exercises three times a day, every weekday, and a walking program twice a week, along with breathing exercises. The supervised video game-based exercise program will include five different five-minute breathing labs and breathing games, two days a week, and 40 minutes of Nintendo Wii Fit games, which include lower extremity, upper extremity, and balance exercises. |
| Conventional Pulmonary Rehabilitation | Active comparator | Behavioral: Home exercisesOnly the unsupervised conventional pulmonary rehabilitation (PR) program will be applied on this group. The conventional PR program will include posture exercises combined with breathing exercises three times a day, every weekday, and a walking program twice a week, along with breathing exercises Conventional PR program including: Breathing exercises (pursed-lip breathing, thoracic expansion, diaphragmatic breathing, breathing control) Postural exercises combined with breathing Walking program (30 min, 2×/week at Borg scale 4-6) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having been diagnosed with mild to moderate interstitial lung disease
- Being between the ages of 20 and 70
- Being referred to the study by their physician
- Being willing and able to participate
- Having no physical or cognitive disability that would prevent them from participating in exercise training
Key exclusion criteria (4 listed)
- Presence of cardiovascular disease (acute heart failure, unstable angina, or recent myocardial infarction, etc.)
- Presence of cognitive impairment that prevents participation in exercise training
- Presence of a history of cerebrovascular accident
- Presence of a history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exercisesProgram Duration: 8 weeks Implementation: The conventional program plus supervised video game-based training sessions. Additional Protocol: Video Game-Based Exercises 1. Breathing Labs - Breathing Games (Slovenia) Frequency: 3 days per week, on non-walking days, supervised at the hospital. Structure: 5 mini-games per session, performed sequentially. Exercises: Balloon: Weeks 1-4: Level 1; Weeks 5-8: Level 2. Focus on sustained controlled exhalation. Plane: Weeks 1-4: ~6 sec breath cycle; Weeks 5-8: ~8 sec breath cycle. Wolf: Weeks 1-4: Easy; Weeks 5-8: Medium. Flowers: Weeks 1-4: Sunflower module; Weeks 5-8: Rose module. Pluto: Weeks 1-4: Easy; Weeks 5-8: Medium. Intensity: Target MBS 4-6/10 for dyspnea and fatigue. 2. Nintendo Wii / Wii Fit - Functional Training Duration: ~5 minutes per game, 30-40 minutes total per session. Games and targets: Lower limb/aerobic: Basic Run, Basic Step, Obstacle Course, Island Cycling. Upper limb: Boxing, Canoe. Balance: Rhythm Parade. | Behavioural | Video game-based exercise training |
| Home exercisesProgram Duration: 8 weeks Implementation: Home-based, instructed face-to-face at baseline by a physiotherapist, supported with video materials, and monitored with regular feedback. A) Posture + Breathing Exercises Frequency: 3 sessions per day (morning, noon, evening) Content: Shoulder girdle mobilization: Scapular elevation-depression, abduction-adduction (3 sets × 3 repetitions). Stretching exercises: Shoulder, cervical, and trunk muscles; 5-second hold at end range. Combined with breathing: Inspiration during concentric phase, expiration during eccentric phase. B) Breathing Exercises Frequency: 3 sessions per day; 10 repetitions of each exercise per session Content: Pursed-Lip Breathing, Thoracic Expansion Exercises, Diaphragmatic Breathing, Breathing Control C) Walking Program Frequency: 2 days per week Duration: 30 minutes (5 min warm-up, 20 min walking, 5 min cool-down) Intensity: Self-selected pace targeting Modified Borg Scale (MBS) 4-6/10 for dyspnea. | Behavioural | Conventional Pulmonary Rehabilitation |
Primary outcome
Forced vital capacity (FVC)
Time frame: Day 1 and at the end of the eighth week
FVC will be measured using a spirometry test. During the assessment, participants will be instructed to take a full breath, and with a nose clip in place, exhale into the spirometer with maximum effort. The procedure will be repeated at least three times, and the best value will be recorded. Results will be expressed in liters (L) and compared to predicted values based on age, height, sex, and ethnicity. A value of ≥80% of the predicted capacity will be considered normal.
Forced Expiratory Volume in 1 Second (FEV₁)
Time frame: Day 1 and at the end of the eighth week
FEV₁ is defined as the volume of air that will be exhaled during the first second of a forced expiration after a full inspiration. It will be measured by spirometry and expressed in liters (L). Results will be compared to predicted values calculated according to age, height, sex, and ethnicity. A value of ≥80% of the predicted capacity will be considered normal.
FEV₁/FVC
Time frame: Day 1 and at the end of the eighth week
The FEV₁/FVC ratio is defined as the proportion of the forced expiratory volume in the first second (FEV₁) to the forced vital capacity (FVC). It will be measured by spirometry. Results will be expressed as a percentage and compared to predicted values according to age, height, sex, and ethnicity. A value of ≥70% will be considered normal, while lower values will indicate airflow limitation.
Peak Expiratory Flow (PEF)
Time frame: Day 1 and at the end of the eighth week
Peak Expiratory Flow (PEF) is defined as the maximum flow rate that will be achieved during a forced expiration after a full inspiration. It will be measured by spirometry and expressed in liters per second (L/s). The procedure will be repeated at least three times, and the best value will be recorded. Results will be compared to predicted values calculated according to age, height, sex, and ethnicity. A value of ≥80% of the predicted capacity will be considered normal.
Lung Diffusion Capacity
Time frame: Day 1 and at the end of the eighth week
Diffusing capacity (DLCO) measurement will be performed with the nose closed after the patient has not exercised before the test and has been sitting for at least 5 minutes. Care should be taken to ensure rapid inspiration. Inspiration time should be kept between 2 and 4 seconds. The final expiration should not exceed 4 seconds. Breath-hold times will be measured for all patients as recommended by the European Respiratory Society (ERS) guidelines. Tests with breath-hold times outside the 9-11 second range, inspirations with inspiratory vital capacity (IVC) below 90% during the DLCO maneuver, and measurements with alveolar ventilation below 10% of total lung capacity will be excluded from the study. DLCO measurements will be performed using gas chromatographs, and the results will be recorded as ml/min/mmHg. Hemoglobin-corrected tests will be used as the basis.
Peripheral muscle strength
Time frame: Day 1 and at the end of the eighth week
Peripheral muscle strength will be measured using a portable manual muscle strength measurement device (Hoggan MicroFet2 Handheld Dynamometer) for shoulder abductor and adductor, shoulder flexor, extensor, elbow flexor and extensor, hip flexor, extensor, hip abductor, adductor, knee flexor, and extensor muscles. Grip strength will be measured using a handheld dynamometer (Jamar, Nottinghamshire, UK) in a sitting position, with the elbow flexed at 90 degrees and the wrist in neutral. Measurements will be repeated three times for the right and left sides, and the average of the values will be recorded in Newtons (N).
Functional Exercise Capacity
Time frame: Day 1 and at the end of the eighth week
Functional exercise capacity will be assessed with the 6-minute walk test (6MWT). Participants are instructed to walk a 30-meter corridor with the goal of covering the longest possible distance in six minutes. Participants are allowed to stop and rest if necessary but are encouraged to continue walking as soon as possible. Participants' heart rate, blood pressure, peripheral oxygen saturation, self-perceived shortness of breath, and lower extremity muscle fatigue are questioned before and after the test. The distance traveled during the six-minute period is recorded. The 6MWT is a valid and reliable test for interstitial lung disease.
6 secondary outcomes
Quality of Life score
Time frame: Day 1 and at the end of the eighth week
The Modified Borg Scale Score
Time frame: Day 1 and at the end of the eighth week
Modified Medical Research Council Scale Score
Time frame: Day 1 and at the end of the eighth week
Fatigue status
Time frame: Day 1 and at the end of the eighth week
Dysfunctional Respiration
Time frame: Day 1 and at the end of the eighth week
Cognitive Function
Time frame: Day 1 and at the end of the eighth week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exercises and Home exercises in people with Interstitial Lung Disease, run by Istinye University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (FVC) (time frame: Day 1 and at the end of the eighth week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.