NCT05762406

Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centro Cardiologico Monzino · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Scientific Rationale: In late 2019 and early 2020, researchers at the Wuhan Institute of Virology identified a potential new etiologic agent, called new coronavirus 2019 (nCoV-2019). Subsequently, the epidemic unleashed by this virus involved the whole world and radically changed the habits of the entire global population. Since that time, in fact, the need to contain the spread of infection through specific social distancing procedures and through the use of personal protective equipment has become compelling. The main tool was the requirement for all citizens to wear masks for airway protection. This measure has thus become in daily use for the majority of the population. Therefore, it has become increasingly important to evaluate the impact of mask wearing on activities of daily living (ADls), both in healthy subjects, for which several evidences have already been brought, and in patients with different diseases, for which data are still insufficient to fully describe the effects. Oxygen consumption and dyspnea during simple activities of daily living (ADLs) have already been studied in patients with heart failure (HF) and chronic obstructive pulmonary disease (COPD), and there is evidence that these subjects compared with healthy subjects perform ADLs at a higher percentage of their peak VO2 with more dyspnea. However, there are still no studies highlighting, however, the consequences of performing such activities while wearing a protective filtering facepiece particles class 2 (FFP2) mask, to date considered the most suitable to preserve the most fragile subjects from infection. In this study, therefore, the investigators aim to asess the effects of these devices on the ability to perform ADLs by evaluating the exchanges of respiratory gases in the body during the performance of normal activities or during sleep in patients with HF or COPD compared with healthy subjects.

Conditions

• Heart Failure
• COPD

Interventions

Type	Name	Description
DEVICE	Respiratory protective mask	Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities while wearing a protective mask. During the exercises, oxygen consumption, ventilation and other cardiorespiratory parameters will be assessed using a portable device (K5, Cosmed)

Timeline

• Start date: 2021-06-16
• Primary completion: 2024-03-15
• Completion: 2024-04-30
• First posted: 2023-03-09
• Last updated: 2024-09-04

Locations

1 site across 1 country: Italy