EFFECT OF COMBINED VIRTUAL REALITY-GUIDED BREATHING AND AEROBIC TRAINING ON VENTILATORY FUNCTION IN PATIENTS WITH COPD

This randomized controlled trial aims to investigate the effects of combining virtual reality (VR)-guided diaphragmatic breathing using Flowborne with VR-based aerobic cycling using Kinneta on ventilatory function in male and female patients aged 45-55 years with stable COPD (GOLD Stage II). Participants will be randomly assigned to either an intervention group receiving combined VR-guided breathing and aerobic cycling or a control group receiving conventional pulmonary rehabilitation with an identical session structure. Both groups will participate in three sessions per week for 12 weeks, with aerobic exercise performed at 65-75% of maximum heart rate (HRmax).

The primary outcomes will be diaphragmatic excursion, assessed using ultrasound, and forced expiratory volume in one second (FEV₁), measured using spirometry. Secondary outcomes will include FVC, FEV1/FVC ratio, six-minute walk test (6MWT) distance, dyspnea severity measured using the Borg scale, smoking index, peripheral oxygen saturation (SpO₂), and COPD Assessment Test (CAT) scores. All outcomes will be assessed at the end of the 12-week intervention period following randomization. The study aims to determine whether integrating VR-guided breathing and aerobic exercise produces greater improvements in diaphragmatic function, pulmonary function, exercise capacity, and overall COPD-related health status compared with conventional pulmonary rehabilitation.

• VR-Based Pulmonary Rehabilitation Group (Behavioral): Participants will perform VR-guided diaphragmatic breathing using Flowborne combined with VR-based aerobic cycling using Kinneta for 12 weeks, three sessions per week.
• Conventional Pulmonary Rehabilitation Group (Behavioral): Participants will perform conventional diaphragmatic breathing exercises combined with conventional aerobic cycling training, following the same session structure and training duration as the experimental group.

Primary outcomes

• Diaphragmatic Excursion [Baseline and 12 weeks after the start of the intervention.]: Change in diaphragmatic excursion, measured in centimeters using diagnostic ultrasound during deep inspiration, from baseline to the end of the intervention period.
• Forced Expiratory Volume in One Second (FEV₁) [Baseline and 12 weeks after the start of the intervention.]: Change in forced expiratory volume in one second (FEV₁), measured using spirometry, from baseline to the end of the 12-week intervention period.

Secondary outcomes

• Forced Vital Capacity (FVC) [Baseline and 12 weeks after the start of the intervention.]: Change in forced vital capacity (FVC), measured using spirometry, from baseline to the end of the intervention period.
• FEV₁/FVC Ratio [Baseline and 12 weeks after the start of the intervention.]: Change in the ratio of forced expiratory volume in one second to forced vital capacity (FEV₁/FVC), measured using spirometry, from baseline to the end of the intervention period.
• Six-Minute Walk Distance (6MWD) [Baseline and 12 weeks after the start of the intervention.]: Change in six-minute walk distance, measured in meters using the standardized six-minute walk test, from baseline to the end of the intervention period.
• Peripheral Oxygen Saturation (SpO₂) [Baseline and 12 weeks after the start of the intervention.]: Change in peripheral oxygen saturation (SpO₂), measured using pulse oximetry, from baseline to the end of the intervention period.

Sex: All, ages: 45 Years to 55 Years

Inclusion Criteria:

* Sixty male patients with chronic obstructive pulmonary disease, diagnosed with stable COPD according to GOLD criteria, defined by spirometric evidence of GOLD stage II airflow limitation (FEV₁ ≥50% and <80% predicted for stage II.
* Their age will range from 45-55s.
* Ability to use a VR headset after training
* Clinically stable condition with no acute exacerbation during the previous 4-6 weeks.
* Ability to ambulate independently and perform aerobic exercise safely.
* Medically cleared by a physician to participate in exercise training.
* Ability to understand and follow instructions.
* Stable pharmacological treatment for at least 4 weeks before participation.
* Patients willing to participate and sign informed consent.

Exclusion Criteria:

* Acute exacerbation of Chronic Obstructive Pulmonary Disease or recent hospitalization.
* Unstable cardiovascular disorders, such as:
* uncontrolled hypertension
* unstable angina
* recent myocardial infarction
* severe arrhythmias
* Severe musculoskeletal disorders limiting exercise performance.
* Neurological disorders affecting balance, gait, or exercise ability.
* Severe cognitive impairment or psychiatric disorders interfering with cooperation.