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Chronic Obstructive Lung DiseaseNCT07015216

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

A study testing VR-Assisted Dual Task Training and Conventional Therapy Program in people with Chronic Obstructive Lung Disease, run by Istinye University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Obstructive Lung Disease
What is being tested?
VR-Assisted Dual Task Training and Conventional Therapy Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Jul 2025to 10 Jan 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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Berrak VARHAN Professor, Dr, PT contact

0850 283 6000

berrak.varhan@istinye.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Istınye University, Istanbul,

    Istanbul

    Berrak VARHAN PHd, 0850 283 6000, berrak.varhan@istinye.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Being tested
VR-Assisted Dual Task Training, Conventional Therapy Program
Keywords
Chronic Obstructive Lung Disease, dual task training, oxygenation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR-Assisted Dual Task TrainingOther

    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.

  • Conventional Therapy ProgramOther

    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.

Study groups in NCT07015216
Study groupRoleWhat they receive
VR-Assisted Dual Task Training GroupExperimentalVirtual 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.
Receives: Other: VR-Assisted Dual Task Training; Other: Conventional Therapy Program
Conventional Therapy ProgramOtherA 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.
Receives: Other: Conventional Therapy Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and after 6 weeks of intervention

  2. 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.

    Measured: Baseline and after 6 weeks of intervention

  3. 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.

    Measured: Baseline and after 6 weeks of intervention

  4. 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.

    Measured: Baseline and after 6 weeks of interventio

  5. 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.

    Measured: Baseline and after 6 weeks of intervention

Secondary outcomes (19)
  1. Dyspnea Severity

    Self-reported scale ranging from 0-4 to assess dyspnea level.

    Measured: Pre- and post-intervention (6 weeks).

  2. Fatigue Severity

    9-item scale to assess fatigue over the past month; each item rated 1-7.

    Measured: Pre- and post-intervention (6 weeks).

  3. Maximal Inspiratory Pressure (MIP)

    MIP will be measured using the Powerbreathe Plus MR device in accordance with ATS/ERS recommendations. This test assesses inspiratory muscle strength.

    Measured: Pre- and post-intervention (6 weeks)

  4. Maximal Expiratory Pressure (MEP)

    MEP will be measured using the Powerbreathe Plus MR device in accordance with ATS/ERS recommendations. This test assesses expiratory muscle strength.

    Measured: Pre- and post-intervention (6 weeks)

  5. Forced Expiratory Volume in 1 Second (FEV₁)

    FEV₁ will be measured using the Cosmed Pony FX spirometer according to ATS/ERS guidelines. This parameter reflects airway obstruction.

    Measured: Pre- and post-intervention (6 weeks)

  6. Forced Vital Capacity (FVC)

    FVC will be measured using the Cosmed Pony FX spirometer in accordance with ATS/ERS standards. It represents the total volume of air exhaled during a forced breath.

    Measured: Pre- and post-intervention (6 weeks)

  7. FEV₁/FVC Ratio

    The ratio of FEV₁ to FVC will be calculated to evaluate airflow limitation. Measurements will be taken using the Cosmed Pony FX spirometer per ATS/ERS guidelines.

    Measured: Pre- and post-intervention (6 weeks)

  8. Peak Expiratory Flow (PEF)

    PEF will be measured using the Cosmed Pony FX spirometer, following ATS/ERS guidelines. It indicates the highest flow achieved during a forced exhalation.

    Measured: Pre- and post-intervention (6 weeks)

  9. Forced Expiratory Flow 25-75% (FEF₂₅-₇₅)

    FEF₂₅-₇₅ will be measured using the Cosmed Pony FX spirometer to assess the flow during the middle half of the forced vital capacity. Measurements follow ATS/ERS standards.

    Measured: Pre- and post-intervention (6 weeks)

  10. Carbon Monoxide Level (Smokerlyzer Device)

    Non-invasive CO level measurement.

    Measured: Pre- and post-intervention (6 weeks).

  11. Daily Living Activities

    (London Chest Activity of Daily Living Scale - LCADL) 15 items scored 0-5 assessing dyspnea in daily tasks.

    Measured: Pre- and post-intervention (6 weeks).

  12. Hand Grip Strength

    Three repeated trials with best score recorded.

    Measured: Pre- and post-intervention (6 weeks).

  13. Flamingo Balance Test

    The Flamingo Balance Test assesses static balance by measuring the ability to maintain a single-leg stance. The participant stands on one leg on a narrow beam, and the number of balance losses (falls) in 60 seconds is recorded. Fewer falls indicate better balance.

    Measured: Pre- and post-intervention (6 weeks)

  14. Functional Reach Test (FRT)

    The Functional Reach Test evaluates dynamic balance by measuring how far a person can reach forward beyond arm's length while maintaining a fixed base of support in standing. The reach distance in centimeters is recorded; longer reach indicates better dynamic balance.

    Measured: Pre- and post-intervention (6 weeks)

  15. Heart Rate Monitoring

    Heart rate (HR) will be measured in beats per minute (bpm) using a pulse oximeter or electrocardiogram. Values will be recorded at rest (pre- and post-intervention) and during recovery following cardiopulmonary exercise testing (CPET) at 1, 3, and 5 minutes.

    Measured: Pre- and post-intervention, and during CPET recovery (1, 3, 5 minutes)

  16. Blood Pressure Measurement

    Systolic and diastolic blood pressure (SBP/DBP) will be measured in mmHg using a standard sphygmomanometer or automated blood pressure device. Measurements will be taken at rest (pre- and post-intervention) and during CPET recovery at 1, 3, and 5 minutes.

    Measured: Pre- and post-intervention, and during CPET recovery (1, 3, 5 minutes

  17. Peripheral Oxygen Saturation (SpO₂)

    SpO₂ will be measured using a fingertip pulse oximeter. Values will be recorded as a percentage (%) at rest (pre- and post-intervention) and during CPET recovery at 1, 3, and 5 minutes.

    Measured: Pre- and post-intervention, and during CPET recovery (1, 3, 5 minutes)

  18. Respiratory Rate Monitoring

    Respiratory rate (breaths per minute) will be measured by manual observation or via monitoring device. Data will be collected at rest (pre- and post-intervention) and at 1, 3, and 5 minutes during CPET recovery.

    Measured: Pre- and post-intervention, and during CPET recovery (1, 3, 5 minutes)

  19. Peripheral Muscle Strength Assessment Using Medical Research Council (MRC) Scale

    Peripheral muscle strength will be evaluated using the Medical Research Council (MRC) scale. This semi-quantitative scale grades muscle strength from 0 (no contraction) to 5 (normal strength) across selected muscle groups, including upper and lower extremities. The total MRC sum score provides an estimate of global muscle strength.

    Measured: Pre- and post-intervention (6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start12 Jul 2025 (estimated)
  3. Primary completion15 Sep 2025 (estimated)
  4. Study completion10 Jan 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Conventional therapy + virtual reality-assisted dual task training
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015216
Sponsor's protocol ID
2025-02
Status last verified
Jun 2025
First submitted
3 Jun 2025
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing VR-Assisted Dual Task Training and Conventional Therapy Program in people with Chronic Obstructive Lung Disease, run by Istinye University at 1 site in Turkey (Türkiye).

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 7 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Berrak VARHAN Professor, Dr, PT (0850 283 6000, berrak.varhan@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Oxygen Uptake (VO₂max) (time frame: Baseline and after 6 weeks of intervention). The study lists 5 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 22 Jun 2025.

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