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Completed

NCT Number: NCT05762406

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Cardiologico Monzino, Irccs

Milan, Italy, 20138

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy subjects:

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

Inclusion criteria

for subjects with HF:

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Evaluation of differences in VO2 expressed in mL/min/kg

    Time frame: 2 weeks

    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. Evaluation of differences in ventilation expressed as L/min

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Evaluation of differences in peripheral saturation (%)

    Time frame: 2 weeks

    Differences in peripheral saturation under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..

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

    Time frame: 2 weeks

    Differences in ventilation/carbon dioxide(VE/VCO2)slope under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.

  3. Evaluation of differences in heart rate (beats/min)

    Time frame: 2 weeks

    Differences in heart rate (HR) under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.

  4. Evaluation of differences in dyspnea (Borg scale)

    Time frame: 2 weeks

    Differences in dyspnea grade evaluated by Borg scale under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.

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

    Time frame: 2 weeks

    Differences in nocturnal apneas under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..

  6. Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal hypopnea (number of events)

    Time frame: 2 weeks

    Differences in nocturnal hypopneas events under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..

  7. Evaluation of differences in nocturnal desaturation (%)

    Time frame: 2 weeks

    Differences in nocturnal desaturation under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2023
Registry last updated
Sep 4, 2024

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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