Clinical trial NCT07015216: Effects of Virtual Reality-Assisted Dual Task Training on Muscle Oxygenation in Patients With COPD
Official title: Investigation of the Effects of Virtual Reality-Assisted Dual Task Training on Cerebral, Peripheral, and Respiratory Muscle Oxygenation in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Keywords: Chronic Obstructive Lung Disease
dual task training
oxygenation
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Conventional therapy + virtual reality-assisted dual task training
Primary purpose: OTHER

Brief summary: Chronic Obstructive Pulmonary Disease (COPD); It is a common but preventable disease that is associated with a chronic inflammatory response in the airways and lungs to noxious gases, often progressive, resulting in a persistent limitation of airflow.

Chronic cough, dyspnea and sputum production are the most common symptoms of the disease. Respiratory failure and decrease in physical activity seen in the later stages of the disease also negatively affect individuals' participation in daily life. COPD, which is an important health problem due to its increasing incidence, high prevalence and associated social and economic costs, ranks fourth among the global causes of death. Cognitive and physical impairments are often associated with COPD prognosis. In the literature, a relationship was found between prefrontal cortex activity, exercise tolerance and dyspnea perception of the individual. The prevalence of cognitive impairment in COPD ranges from 10 to 61%. Considering the effect of cognitive function on motor control, it is thought to affect physical performance. Studies have reported that prefrontal cortex oxygenation and perfusion increase with exercise. Depending on the positive effect of neuron metabolism, increases in cognitive and physical functions are observed.

When we look at the results of dual-task training and virtual reality applications in geriatric and neurological population, there are positive effects on physical and cognitive functions. Dual-task training causes an increase in cerebral perfusion and oxyhemoglobin as it requires more cognitive resources. Therefore, it is important to create a program that includes cognitive performance rather than focusing only on motor performance in the rehabilitation of patients with COPD. Virtual reality applications are also widely used in many areas. A limited number of studies conducted on individuals with COPD have shown positive effects on physical performance. When we look at the literature, we see that there is no study investigating the effects of virtual reality-assisted dual- task training in individuals with COPD. Based on this information, we aim to evaluate the effect of virtual reality supported dual-task training on cerebral, peripheral muscle and respiratory muscle oxygenation in individuals with COPD using fNIRS imaging method. The 30 individuals with COPD included in the study will be divided into two groups as intervention and control groups. In addition to the conventional physiotherapy and rehabilitation program, virtual reality supported dual task training will be given to the intervention group. In the control group, only conventional physiotherapy and rehabilitation program will be applied. The treatment program will continue for 6 weeks, 3 days a week in both groups. Within the scope of our project, respiratory muscle strength, respiratory function, peripheral muscle strength, fatigue, balance, functional capacity, activity of daily living, cognitive level, cerebral, peripheral and respiratory muscle oxygenation of both groups will be evaluated before and after the application and the effects of the application will be examined. For these purposes, our study will be the first study in the literature to evaluate the effect of virtual reality supported dual-task training in terms of cognitive functions and oxygenation and compare it with conventional physiotherapy applications.

Our study results will provide an idea for the determination of an optimal non-pharmacological treatment method to protect and increase physical and cognitive performance in individuals with COPD. In addition, we think that our study will have a social impact by helping to reduce mortality and morbidity rates in these patients and indirectly to alleviate the burden of health care services.

This project will contribute to the literature by providing a different perspective for clinical applications, as well as being a guide for future studies


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD stage 2 or 3 according to GOLD classification
* No orthopedic and/or neuromuscular conditions that would interfere with dual-task training
* Ability to ambulate
* Adequate cognitive level to participate in the training (Mini Mental State Examination score ≥ 23)
* Voluntary participation

Exclusion Criteria:

* Presence of vestibular problems that would interfere with virtual reality applications
* Visual impairments
* Any medical condition contraindicating exercise participation
* Being in an acute exacerbation period
* Having an active infection
* Diagnosis of cancer
* Known cardiovascular disease

Primary outcomes:
measure: Maximal Oxygen Uptake (VO₂max)
timeFrame: Baseline and after 6 weeks of intervention
measure: Cognitive Function (MoCA Score)
timeFrame: Baseline and after 6 weeks of intervention
measure: Dual Task Effect on Gait Speed (DTE %)
timeFrame: Baseline and after 6 weeks of intervention
measure: Cortical Activation During Dual Tasks - Oxyhemoglobin (O₂Hb)
timeFrame: Baseline and after 6 weeks of interventio
measure: Cortical Activation During Dual Tasks - Deoxyhemoglobin (HHb)
timeFrame: Baseline and after 6 weeks of intervention
Secondary outcomes:
measure: Dyspnea Severity
timeFrame: Pre- and post-intervention (6 weeks).
measure: Fatigue Severity
timeFrame: Pre- and post-intervention (6 weeks).
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Maximal Expiratory Pressure (MEP)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Forced Expiratory Volume in 1 Second (FEV₁)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Forced Vital Capacity (FVC)
timeFrame: Pre- and post-intervention (6 weeks)
measure: FEV₁/FVC Ratio
timeFrame: Pre- and post-intervention (6 weeks)
measure: Peak Expiratory Flow (PEF)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Forced Expiratory Flow 25-75% (FEF₂₅-₇₅)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Carbon Monoxide Level (Smokerlyzer Device)
timeFrame: Pre- and post-intervention (6 weeks).
measure: Daily Living Activities
timeFrame: Pre- and post-intervention (6 weeks).
measure: Hand Grip Strength
timeFrame: Pre- and post-intervention (6 weeks).
measure: Flamingo Balance Test
timeFrame: Pre- and post-intervention (6 weeks)
measure: Functional Reach Test (FRT)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Heart Rate Monitoring
timeFrame: Pre- and post-intervention, and during CPET recovery (1, 3, 5 minutes)
measure: Blood Pressure Measurement
timeFrame: Pre- and post-intervention, and during CPET recovery (1, 3, 5 minutes
measure: Peripheral Oxygen Saturation (SpO₂)
timeFrame: Pre- and post-intervention, and during CPET recovery (1, 3, 5 minutes)
measure: Respiratory Rate Monitoring
timeFrame: Pre- and post-intervention, and during CPET recovery (1, 3, 5 minutes)
measure: Peripheral Muscle Strength Assessment Using Medical Research Council (MRC) Scale
timeFrame: Pre- and post-intervention (6 weeks)
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Istınye University, Istanbul,
Study officials:
References: