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

NCT05762406 | Completed

• 1 other identifier: CCM1550
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Evaluation of differences in VO2 expressed in mL/min/kg

  Differences in oxygen consumption (VO2) in different daily activities under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.

  2 weeks

• Evaluation of differences in ventilation expressed as L/min

  Differences in ventilation (VE) in different daily activities under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.

  2 weeks

Secondary Outcomes (7)

• Evaluation of differences in peripheral saturation (%)

  2 weeks

• Evaluation of differences in VE/VCO2 (slope during the exercise)

  2 weeks

• Evaluation of differences in heart rate (beats/min)

  2 weeks

• Evaluation of differences in dyspnea (Borg scale)

  2 weeks

• Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal apneas (number of events)

  2 weeks

Study Arms (2)

Wearing mask

EXPERIMENTAL

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

Device: Respiratory protective mask

Not wearing mask

NO INTERVENTION

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

Interventions

Respiratory protective mask 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)

Wearing mask

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Healthy subjects:
• Presence of concomitant diseases
• Patients:
• Oxygen therapy
• Inability or contraindication to perform a maximal CPET

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead

Study Sites (1)

Centro Cardiologico Monzino, Irccs

Milan, Italy, 20138, Italy

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 9, 2023
• Study Start: June 16, 2021
• Primary Completion: March 15, 2024
• Study Completion: April 30, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)