Combinaison of Virtual Reality and Rehabilitation to Improve Muscle Function, Exercise Tolerance, Exertional Symptoms and Dyspnea in Patients with Chronic Respiratory Disease: a Randomized Cross-over Trial

NCT ID: NCT06811402

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-31

Brief Summary

Chronic respiratory diseases, such as Chronic Obstructive Pulmonary Disease (COPD), are a leading cause of death globally. These diseases not only contribute significantly to mortality but also lead to a decline in physical capacity, limiting daily activities and perpetuating a vicious cycle of deconditioning. Dyspnea (shortness of breath) is a major symptom, seen in 56 to 98% of COPD patients, and is linked to decreased exercise tolerance and muscle dysfunction. It often leads to reduced physical activity, further worsening respiratory function and quality of life. Dyspnea severity is associated with increased mortality, hospitalizations, and anxiety. The main therapeutic approach for these patients is pulmonary rehabilitation, which improves exercise tolerance, quality of life, and reduces hospitalizations and exacerbations. However, dyspnea limits exercise and is often a barrier to continued physical activity.

Virtual reality (VR) technology has shown promise in managing symptoms like pain, anxiety, and dyspnea by providing a distraction. Studies suggest that VR can improve dyspnea and anxiety, particularly in patients hospitalized for conditions like COVID-19. However, research on VR's immediate effects on exercise capacity is limited, with most studies focusing on non-immersive exergames rather than immersive VR. The potential of VR to improve exercise tolerance in patients with chronic respiratory diseases remains uncertain. Our study aims to test this hypothesis through a randomized crossover trial to assess VR's impact on dyspnea and exercise tolerance in these patients.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Patient will undergo the rehabilitation session as the usual without the virtual reality mask.

Group Type: NO_INTERVENTION

No interventions assigned to this group

VR

the patient will undergo the rehabilitation session with a virtual reality mask

Group Type: EXPERIMENTAL

virtual reality

Intervention Type: OTHER

the patient will wear a VR mask during the session

Interventions

virtual reality

the patient will wear a VR mask during the session

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient aged 18 years or older
• Patient with a chronic respiratory disease requiring pulmonary rehabilitation
• Patient with dyspnea assessed as mMRC ≥ 0 (Annex 3)
• Patient undergoing pulmonary rehabilitation at the Paris Saint-Joseph Hospital
• Patient affiliated with a health insurance plan
• French-speaking patient
• Patient who has provided informed, explicit, and voluntary oral consent

Exclusion Criteria

• Contraindications for an endurance reconditioning program (neurodegenerative diseases, severe neurological deficits, unstable cardiovascular diseases)
• History of motion sickness, vertigo, vestibular impairment, labyrinthitis
• History of seizures or other neurological or psychiatric comorbidities
• Severe visual impairments
• Patient already included in a Type 1 interventional research protocol (RIPH1)
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection
• Pregnant or breastfeeding patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Paris Saint Joseph

Paris, Paris, France

Countries

France

Central Contacts

Johan Wormser

Role: CONTACT

jwormser@ghpsj.fr

0144123085

Facility Contacts

Juliette Courtiade Mahler, PhD

Role: primary

jcourtiade@ghpsj.fr

+33144127963

Other Identifiers

OVERMUSCLED

Identifier Type: -

Identifier Source: org_study_id