NCT05762406Completed
Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 4 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 16 Feb 2023
- Start date
- 16 Jun 2021
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- Centro Cardiologico Monzino
- Diseases
- Heart failure, COPD
- NCT number
- NCT05762406
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 16 Jun 2021 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of concomitant diseases
- Patients:
- Oxygen therapy
Other
- Healthy subjects:
- Inability or contraindication to perform a maximal CPET
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Cardiologico Monzino IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.