The Effect of Video Game-Based Exercise Training in Patients With Interstitial Lung Disease

NCT07167238 | Not Yet Recruiting DMC

• 1 other identifier: 2025/353
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Conditions

Interstitial Lung Disease

Keywords

Interstitial lung disease; Video game; Exercise training; Functional exercise capacity; Respiratory parameters

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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).

  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.

  Day 1 and at the end of the eighth week

Secondary Outcomes (6)

• Quality of Life score

  Day 1 and at the end of the eighth week

• The Modified Borg Scale Score

  Day 1 and at the end of the eighth week

• Modified Medical Research Council Scale Score

  Day 1 and at the end of the eighth week

• Fatigue status

  Day 1 and at the end of the eighth week

• Dysfunctional Respiration

  Day 1 and at the end of the eighth week

Study Arms (2)

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.

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)

Behavioral: Home exercises

Interventions

Virtual reality exercises BEHAVIORAL

Program 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.

Video game-based exercise training

Home exercises BEHAVIORAL

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. 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.

Conventional Pulmonary Rehabilitation

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 11, 2025
• Study Start: January 25, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12