An interventional study of VR-Based Pulmonary Rehabilitation Group and Conventional Pulmonary Rehabilitation Group in Chronic Obstructive Lung Disease, sponsored by Cairo University. Not yet recruiting. Open to participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
This Single-blind, randomized controlled trial will evaluate the effects of 12 weeks of combined VR-guided diaphragmatic breathing (Flowborne) and VR-aerobic cycling (Kinneta) compared with conventional pulmonary rehabilitation in male and female patients aged 45-55 years with stable COPD (GOLD Stage II). Both groups will train three times weekly at 65-75% HRmax. Primary outcomes are diaphragmatic excursion and FEV₁, while secondary outcomes include FVC, FEV1/FVC ratio, 6MWT, Borg dyspnea score, smoking index, SpO₂, and CAT score. All outcomes will be assessed at the end of the 12-week intervention.
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Participants will receive VR-guided diaphragmatic breathing using Flowborne combined with VR-based aerobic cycling using Kinneta for 12 weeks, three sessions per week.
Behavioral: VR-Based Pulmonary Rehabilitation Group
Participants will receive conventional diaphragmatic breathing exercises combined with conventional aerobic cycling training, following the same session structure and training duration as the experimental group.
Behavioral: Conventional Pulmonary Rehabilitation Group
Participants will perform VR-guided diaphragmatic breathing using Flowborne combined with VR-based aerobic cycling using Kinneta for 12 weeks, three sessions per week.
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.
Diaphragmatic Excursion
Change in diaphragmatic excursion, measured in centimeters using diagnostic ultrasound during deep inspiration, from baseline to the end of the intervention period.
Time frame: Baseline and 12 weeks after the start of the intervention.
Forced Expiratory Volume in One Second (FEV₁)
Change in forced expiratory volume in one second (FEV₁), measured using spirometry, from baseline to the end of the 12-week intervention period.
Time frame: Baseline and 12 weeks after the start of the intervention.
Forced Vital Capacity (FVC)
Change in forced vital capacity (FVC), measured using spirometry, from baseline to the end of the intervention period.
Time frame: Baseline and 12 weeks after the start of the intervention.
FEV₁/FVC Ratio
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.
Time frame: Baseline and 12 weeks after the start of the intervention.
Six-Minute Walk Distance (6MWD)
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.
Time frame: Baseline and 12 weeks after the start of the intervention.
Peripheral Oxygen Saturation (SpO₂)
Change in peripheral oxygen saturation (SpO₂), measured using pulse oximetry, from baseline to the end of the intervention period.
Time frame: Baseline and 12 weeks after the start of the intervention.
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared with other researchers. Only aggregated study results will be reported in publications. This decision is based on the absence of a planned data-sharing arrangement for this study.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →