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

NCT ID: NCT05762406

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2024-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Wearing mask

Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities while wearing a protective mask

Group Type: EXPERIMENTAL

Respiratory protective mask

Intervention Type: DEVICE

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)

Not wearing mask

Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities in basal conditions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Healthy subjects:

• Age: 18-80 years
• Not taking cardiovascular medications
• No history of cardiovascular disease
• Normal physical examination
• Normal ECG

• Age: 18-80 years
• New York Heart Association Class (NYHA) II to III in stable clinical condition
• Left ventricular ejection fraction (LVEF) <40%
• Ability to perform a maximal CPET

Patients with COPD:

• Age: 18-80 years
• Diagnosis of COPD stage GOLD II-III in stable clinical condition
• Absent concomitant heart disease
• Ability to perform a maximal CPET

Exclusion Criteria

• Healthy subjects:
• Presence of concomitant diseases

Patients:

• Oxygen therapy
• Inability or contraindication to perform a maximal CPET

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Cardiologico Monzino, Irccs

Milan, Italy, Italy

Countries

Italy

Other Identifiers

CCM1550

Identifier Type: -

Identifier Source: org_study_id