Effects of Virtual Reality-Assisted Dual Task Training on Muscle Oxygenation in Patients With COPD

NCT07015216 | Recruiting

• 1 other identifier: 2025-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) 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 the participants' 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 examining the results of dual-task training and virtual reality applications in geriatric and neurological populations, positive effects on physical and cognitive functions have been demonstrated. Dual-task training causes an increase in cerebral perfusion and oxyhemoglobin as it requires more cognitive resources. Therefore, it is important for the investigators 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 examining the literature, it is seen that there is no study investigating the effects of virtual reality-assisted dual-task training in individuals with COPD. Based on this information, the investigators 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 the 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 the 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 the project, respiratory muscle strength, respiratory function, peripheral muscle strength, fatigue, balance, functional capacity, activity of daily living, cognitive level, and cerebral, peripheral, and respiratory muscle oxygenation of both groups will be evaluated before and after the intervention, and the effects of the intervention will be examined. For these purposes, the study will be the first 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. The study results will provide a basis for determining an optimal non-pharmacological treatment method to protect and improve physical and cognitive performance in individuals with COPD. In addition, the investigators believe that the study will have a social impact by helping to reduce mortality and morbidity rates in these patients and indirectly alleviate the burden on healthcare services. This project will contribute to the literature by providing a different perspective for clinical applications, as well as serving as a guide for future studies.

Conditions

Chronic Obstructive Lung Disease

Keywords

Chronic Obstructive Lung Disease; dual task training; oxygenation

Outcome Measures

Primary Outcomes (5)

• Maximal Oxygen Uptake (VO₂max)

  Maximal oxygen consumption (VO₂max) will be measured during incremental cardiopulmonary exercise testing (CPET) using a COSMED metabolic system and cycle ergometer. VO₂max is defined as the highest oxygen uptake achieved during the final stage of exercise.

  Baseline and after 6 weeks of intervention

• Cognitive Function (MoCA Score)

  Cognitive status will be assessed using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with lower scores indicating more severe impairment.

  Baseline and after 6 weeks of intervention

• Dual Task Effect on Gait Speed (DTE %)

  The effect of performing a cognitive task while walking will be quantified as the percentage change in gait speed compared to normal walking.

  Baseline and after 6 weeks of intervention

• Cortical Activation During Dual Tasks - Oxyhemoglobin (O₂Hb)

  Functional near-infrared spectroscopy (fNIRS) will be used to measure changes in cortical oxyhemoglobin (O₂Hb) levels during dual task performance, indicating increased neural activation.

  Baseline and after 6 weeks of interventio

• Cortical Activation During Dual Tasks - Deoxyhemoglobin (HHb)

  Functional near-infrared spectroscopy (fNIRS) will be used to measure changes in cortical deoxyhemoglobin (HHb) levels during dual task performance, reflecting changes in oxygen consumption and blood flow.

  Baseline and after 6 weeks of intervention

Secondary Outcomes (19)

• Dyspnea Severity

  Pre- and post-intervention (6 weeks).

• Fatigue Severity

  Pre- and post-intervention (6 weeks).

• Maximal Inspiratory Pressure (MIP)

  Pre- and post-intervention (6 weeks)

• Maximal Expiratory Pressure (MEP)

  Pre- and post-intervention (6 weeks)

• Forced Expiratory Volume in 1 Second (FEV₁)

  Pre- and post-intervention (6 weeks)

Study Arms (2)

VR-Assisted Dual Task Training Group

EXPERIMENTAL

Virtual reality-based training will be conducted at ISÜFİZYOTEM in a custom-designed augmented VR environment. A 3D avatar and interactive scene (a 1 km crowded street) will be developed using Blender and Adobe Mixamo, with audio components from the Unity Asset Store. Participants will follow the avatar and perform exercises via a VR headset. After 1 minute of self-paced walking, a three-stage Stroop test will be introduced as a dual-task challenge. Sessions will be 20 minutes, supervised by a physiotherapist, with optional breaks. The intervention will be performed 3 times per week for 6 weeks.

Other: VR-Assisted Dual Task Training; Other: Conventional Therapy Program

Conventional Therapy Program

OTHER

A pulmonary rehabilitation program will be administered to individuals with COPD once daily, three days per week for six weeks. The program will include diaphragmatic, chest, and bilateral segmental breathing exercises, breathing control training, relaxation positioning, peripheral muscle strengthening, and airway clearance techniques. Exercises will be explained and prescribed as a home-based program, to be performed twice daily with 10 repetitions. Patients will be given a daily log sheet to record adherence, which will be regularly monitored.

Other: Conventional Therapy Program

Interventions

VR-Assisted Dual Task Training OTHER

Virtual reality-based training will be conducted at ISÜFİZYOTEM in a custom-designed augmented VR environment. A 3D avatar and interactive scene (a 1 km crowded street) will be developed using Blender and Adobe Mixamo, with audio components from the Unity Asset Store. Participants will follow the avatar and perform exercises via a VR headset. After 1 minute of self-paced walking, a three-stage Stroop test will be introduced as a dual-task challenge. Sessions will be 20 minutes, supervised by a physiotherapist, with optional breaks. The intervention will be performed 3 times per week for 6 weeks.

VR-Assisted Dual Task Training Group

Conventional Therapy Program OTHER

A pulmonary rehabilitation program will be administered to individuals with COPD once daily, three days per week for six weeks. The program will include diaphragmatic, chest, and bilateral segmental breathing exercises, breathing control training, relaxation positioning, peripheral muscle strengthening, and airway clearance techniques. Exercises will be explained and prescribed as a home-based program, to be performed twice daily with 10 repetitions. Patients will be given a daily log sheet to record adherence, which will be regularly monitored.

Conventional Therapy Program; VR-Assisted Dual Task Training Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istınye University, Istanbul,

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Berrak VARHAN Professor, Dr, PT

CONTACT

0850 283 6000; berrak.varhan@istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: Conventional therapy + virtual reality-assisted dual task training

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: July 12, 2025
• Primary Completion: September 15, 2025
• Study Completion: January 10, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

TU (1)