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Not yet recruiting NCT07167238

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

No phase Interventional Interstitial Lung Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality exercises, Home exercises.
Who it may be relevant to
Registry conditions: Interstitial Lung Disease. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral Virtual reality exercises
    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
  • Behavioral Home exercises
    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 breathi

Primary outcome measures

  • Forced vital capacity (FVC) [Time frame: Day 1 and at the end of the eighth week]
  • Forced Expiratory Volume in 1 Second (FEV₁) [Time frame: Day 1 and at the end of the eighth week]
  • FEV₁/FVC [Time frame: Day 1 and at the end of the eighth week]
  • Peak Expiratory Flow (PEF) [Time frame: Day 1 and at the end of the eighth week]
  • Lung Diffusion Capacity [Time frame: Day 1 and at the end of the eighth week]
  • Peripheral muscle strength [Time frame: Day 1 and at the end of the eighth week]
  • Functional Exercise Capacity [Time frame: Day 1 and at the end of the eighth week]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07167238 · 2025/353

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗