Chronic Obstructive Lung DiseaseVR-COPDNCT07885995
EFFECT OF COMBINED VIRTUAL REALITY-GUIDED BREATHING AND AEROBIC TRAINING ON VENTILATORY FUNCTION IN PATIENTS WITH COPD
A study testing VR-Based Pulmonary Rehabilitation Group and Conventional Pulmonary Rehabilitation Group in people with Chronic Obstructive Lung Disease, run by Cairo University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Chronic Obstructive Lung Disease
- What is being tested?
- VR-Based Pulmonary Rehabilitation Group and Conventional Pulmonary Rehabilitation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Apr 2027
- 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 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- Ability to understand and follow instructions.
- Stable pharmacological treatment for at least 4 weeks before participation.
- Patients willing to participate and sign informed consent.
Who cannot join
- Acute exacerbation of Chronic Obstructive Pulmonary Disease or recent hospitalization.
- Unstable cardiovascular disorders, such as:
- uncontrolled hypertension
- unstable angina
- recent myocardial infarction
- severe arrhythmias
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- Severe musculoskeletal disorders limiting exercise performance.
- Neurological disorders affecting balance, gait, or exercise ability.
- Severe cognitive impairment or psychiatric disorders interfering with cooperation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Obstructive Lung Disease
- Being tested
- VR-Based Pulmonary Rehabilitation Group, Conventional Pulmonary Rehabilitation Group
- Keywords
- COPD, Virtual reality, breathing exercise, aerobic exercise
- 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-Based Pulmonary Rehabilitation GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-Based Pulmonary Rehabilitation Group | Experimental | Participants will receive VR-guided diaphragmatic breathing using Flowborne combined with VR-based aerobic cycling using Kinneta for 12 weeks, three sessions per week. Receives: Behavioral: VR-Based Pulmonary Rehabilitation Group |
| Conventional Pulmonary Rehabilitation Group | Active comparator | 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. Receives: Behavioral: Conventional Pulmonary Rehabilitation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic Excursion
Change in diaphragmatic excursion, measured in centimeters using diagnostic ultrasound during deep inspiration, from baseline to the end of the intervention period.
Measured: 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.
Measured: Baseline and 12 weeks after the start of the intervention.
Secondary outcomes (4)
Forced Vital Capacity (FVC)
Change in forced vital capacity (FVC), measured using spirometry, from baseline to the end of the intervention period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks after the start of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Yehia Nasr Elsayed Moustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885995
- Sponsor's protocol ID
- 015/003032
- Acronym
- VR-COPD
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF COMBINED VIRTUAL REALITY-GUIDED BREATHING AND AEROBIC TRAINING ON VENTILATORY FUNCTION IN PATIENTS WITH COPD
- ClinicalTrials.gov ID
- NCT07885995
- Acronym / sponsor ID
- VR-COPD / 015/003032
- Conditions
- Chronic Obstructive Lung Disease
- Keywords
- COPD, Virtual reality, breathing exercise, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-Based Pulmonary Rehabilitation Group | Experimental | Behavioral: VR-Based Pulmonary Rehabilitation GroupParticipants will receive 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 | Active comparator | Behavioral: Conventional Pulmonary Rehabilitation GroupParticipants will receive conventional diaphragmatic breathing exercises combined with conventional aerobic cycling training, following the same session structure and training duration as the experimental group. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- Acute exacerbation of Chronic Obstructive Pulmonary Disease or recent hospitalization.
- Unstable cardiovascular disorders, such as:
- uncontrolled hypertension
- unstable angina
- recent myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-Based Pulmonary Rehabilitation GroupParticipants will perform VR-guided diaphragmatic breathing using Flowborne combined with VR-based aerobic cycling using Kinneta for 12 weeks, three sessions per week. | Behavioural | VR-Based Pulmonary Rehabilitation Group |
| Conventional Pulmonary Rehabilitation GroupParticipants will perform conventional diaphragmatic breathing exercises combined with conventional aerobic cycling training, following the same session structure and training duration as the experimental group. | Behavioural | Conventional Pulmonary Rehabilitation Group |
Primary outcome
Diaphragmatic Excursion
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Baseline and 12 weeks after the start of the intervention.
FEV₁/FVC Ratio
Time frame: Baseline and 12 weeks after the start of the intervention.
Six-Minute Walk Distance (6MWD)
Time frame: Baseline and 12 weeks after the start of the intervention.
Peripheral Oxygen Saturation (SpO₂)
Time frame: Baseline and 12 weeks after the start of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Based Pulmonary Rehabilitation Group and Conventional Pulmonary Rehabilitation Group in people with Chronic Obstructive Lung Disease, run by Cairo University.
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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 HEND ELMONAEM ABD EL-MONAEM, Phd (0201115507195, drhend@cu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic Excursion (time frame: Baseline and 12 weeks after the start of the intervention.). The study lists 2 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 21 Oct 2026.