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NCT Number: NCT06811402

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

the patient will wear a VR mask during the session

Primary outcomes

  1. Effort duration

    Time frame: twice a week during up to 4 weeks

    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)."

Study contacts

Contact information is provided by the study sponsor or research team.

Johan Wormser

CONTACT

[email protected]

0144123085

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: OVERMUSCLED

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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