Clinical trial NCT05762406: Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease
Official title: Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
COPD
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of differences in VO2 expressed in mL/min/kg
timeFrame: 2 weeks
measure: Evaluation of differences in ventilation expressed as L/min
timeFrame: 2 weeks
Secondary outcomes:
measure: Evaluation of differences in peripheral saturation (%)
timeFrame: 2 weeks
measure: Evaluation of differences in VE/VCO2 (slope during the exercise)
timeFrame: 2 weeks
measure: Evaluation of differences in heart rate (beats/min)
timeFrame: 2 weeks
measure: Evaluation of differences in dyspnea (Borg scale)
timeFrame: 2 weeks
measure: Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal apneas (number of events)
timeFrame: 2 weeks
measure: Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal hypopnea (number of events)
timeFrame: 2 weeks
measure: Evaluation of differences in nocturnal desaturation (%)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Cardiologico Monzino, Irccs
Study officials:
References: