Impact of Immersive Virtual Reality (IVR) on Respiratory Effort: A Pilot Study in Healthy Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorPontificia Universidad Catolica de Chile
About this trial
This pilot randomized crossover study will evaluate the acute effects of immersive virtual reality (IVR) on respiratory effort during submaximal exercise in healthy adults. Dyspnea and increased respiratory effort are influenced not only by mechanical and metabolic factors, but also by emotional and central neural inputs. IVR has shown potential to reduce anxiety, promote relaxation, and modulate physiological responses, but its direct effect on respiratory effort has not been adequately studied.
Healthy adults will complete two experimental exercise sessions: one session with IVR and one session without IVR, in randomized order. In both conditions, participants will perform a 6-minute constant-load cycling test at a submaximal workload individualized from a prior incremental exercise test. Respiratory effort will be assessed continuously using esophageal pressure monitoring. Additional measurements will include ventilatory variables, perceived dyspnea, acute state anxiety, heart rate, oxygen saturation, and heart rate variability.
The primary aim is to determine whether IVR reduces respiratory effort compared with the control condition. This pilot study is intended to provide physiological evidence on the potential role of IVR as a non-pharmacological strategy to modulate respiratory effort and dyspnea, and to inform future research in clinical populations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults aged 18-40 years
Ability to perform cycle ergometer exercise testing
No known history of cardiovascular, pulmonary, neurological, or metabolic disease
Disqualifiers
Current respiratory symptoms or acute illness
Known cardiovascular, pulmonary, neurological, or metabolic disease
Use of medications that may affect respiratory or cardiovascular responses to exercise
Contraindications to exercise testing according to standard clinical guidelines
Trial design
Design model
Crossover
Treatments tested in this trial
Immersive Virtual Reality
BehavioralParticipants are exposed to immersive virtual reality using a head-mounted display during a constant-load submaximal cycling exercise test. The virtual environment provides visual and auditory immersion designed to induce a sense of presence and relaxation. Exercise intensity is individualized based on a prior incremental cardiopulmonary exercise test. The intervention is intended to evaluate the acute effects of immersive virtual reality on respiratory effort, ventilatory responses, and perceived dyspnea during exercise.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Immersive Virtual Reality During ExerciseExperimental treatment 1 intervention
Group B: Exercise Without Virtual Reality (Control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Esophageal pressure swing (ΔPes)
Esophageal pressure swing (ΔPes), defined as the absolute difference between end-expiratory and end-inspiratory esophageal pressure, measured using an esophageal balloon catheter.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.2
Pressure-time product per minute (PTPmin)
Pressure-time product per minute (PTPmin), expressed as cmH₂O·s/min, measured using an esophageal balloon catheter as an index of global inspiratory effort.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.3
Modified Borg dyspnea score (0-10)
Dyspnea intensity will be assessed using the modified Borg scale, a self-reported numerical rating scale ranging from 0 to 10, where 0 indicates no breathing discomfort and 10 indicates maximal breathing discomfor
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.Secondary outcomes
1
Early inspiratory esophageal pressure (Pes at 100 ms)
Early inspiratory esophageal pressure measured 100 ms after the onset of inspiratory effort using the esophageal pressure signal obtained from an esophageal balloon catheter. This parameter is used as an index of central respiratory drive.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.2
Peak inspiratory flow (PIF)
Peak inspiratory flow will be measured breath-by-breath during exercise using a flow sensor and mouthpiece connected to a pneumotachograph. The highest inspiratory flow generated during each respiratory cycle will be recorded and analyzed.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.3
Peak expiratory flow (PEF)
Peak expiratory flow will be measured breath-by-breath during exercise using a mouthpiece with nose clip and a flow sensor connected to a pneumotachograph. The highest expiratory flow generated during each respiratory cycle will be recorded and analyzed.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.4
Inspiratory time (Ti)
Inspiratory time will be measured breath-by-breath from the airflow signal obtained using a mouthpiece with nose clip and a flow sensor connected to a pneumotachograph. Inspiratory time is defined as the duration from the onset of inspiratory airflow to the end of inspiration for each respiratory cycle.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.Other outcomes
1
Peripheral oxygen saturation (SpO₂)
Peripheral oxygen saturation will be measured continuously during exercise using pulse oximetry. The device will provide non-invasive monitoring of arterial oxygen saturation throughout the exercise protocol.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.2
Heart rate (HR)
Heart rate will be measured continuously during exercise using a chest strap heart rate monitor. The device records beat-by-beat heart rate derived from the cardiac electrical signal detected at the chest.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.3
Heart rate variability (RMSSD)
Heart rate variability will be assessed using the root mean square of successive differences between adjacent R-R intervals (RMSSD). R-R intervals will be obtained from a chest strap heart rate monitor recording beat-to-beat cardiac intervals. RMSSD will be calculated as an index of parasympathetic modulation of heart rate.
Time frame
At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.Sponsors and contacts
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Source ClinicalTrials.gov