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

NCT06811402 | Not Yet Recruiting

• 1 other identifier: OVERMUSCLED
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Effort duration

  Compare the total duration of effort during a constant-load test on a cycle ergometer between rehabilitation with VR immersion and rehabilitation alone. Total duration of sustained effort during a constant-load test (in seconds)."

  twice a week during up to 4 weeks

Study Arms (2)

Control

NO INTERVENTION

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

VR

EXPERIMENTAL

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

Other: virtual reality

Interventions

virtual reality OTHER

the patient will wear a VR mask during the session

VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Hôpital Paris Saint Joseph

Paris, Paris, 75014, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Johan Wormser

CONTACT

0144123085; jwormser@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 6, 2025
• Study Start: March 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)