Clinical trial NCT04693975: Social Distancing During the COVID-19 Pandemic and People Living With Chronic Respiratory Diseases
Official title: Impact of Social Distancing During the COVID-19 Pandemic on Non-infected People With Chronic Respiratory Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Idiopathic Pulmonary Fibrosis
Asthma Chronic
Keywords: physical inactivity
sedentarism
chronic lung diseases
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects living with a chronic lung disease who are not infected with SARS-CoV-2.

Brief summary: Social distancing during the COVID-19 pandemic could lead to clinical and functional deterioration of people living with chronic respiratory diseases (CRD). As they are considered risk group for COVID-19, it is not recommended that they leave their house and have interaction with people outside. Thus, most of them have not been attend Pulmonary Rehabilitation sections since the beginning of pandemic, neither exercising outdoor, experiencing drastic restrictions in their activities of daily living.

It is well known that low level of physical activity in daily life (PADL) in this population is related to poor prognosis, including higher chance of hospitalization due to exacerbation and mortality. Therefore, the aim of this study is to evaluate the short- and mid-term impact of the COVID-19 pandemic on the clinical, physical and functional conditions and the PADL level of people living with CRD (chronic obstructive pulmonary disease, asthma and interstitial lung diseases).

Participants will be assessed during the social isolation period and they will be reassessed immediately after release from social isolation. Thus, the subjects will be followed-up during 12 months to record symptoms, functional status, quality of life, exacerbations and hospitalizations.

The researchers' hypothesis is that those patients will present very low level of PADL in association to sedentarism, poor functional status, more symptoms of dyspnoea, anxiety and depression, poor sleep quality and, consequently, will present more episodes of acute exacerbation of the disease and more hospital admission during the study protocol.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease, asthma or interstitial lung disease;
* Absence of any severe and/or unstable cardiac disease;
* Absence of any orthopedic or neuromuscular condition that limits physical activity in daily life.

Exclusion Criteria:

* Desire to leave the study at any time;
* Infection with SARS-CoV-2 during the study protocol.

Primary outcomes:
measure: Physical activity in daily life
timeFrame: 24 months
measure: Patient's perception of physical activity in daily life
timeFrame: 24 months
Secondary outcomes:
measure: Dyspnoea sensation in daily living
timeFrame: 24 months
measure: Acute exacerbation
timeFrame: 24 months
measure: Hospitalization
timeFrame: 24 months
measure: Functional status
timeFrame: 24 months
measure: Health-related Quality of life
timeFrame: 24 months
measure: Health-related Quality of life
timeFrame: 24 months
measure: Sleep quality
timeFrame: 24 months
measure: Anxiety and depression
timeFrame: 24 months
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Laboratory of Reasearch in Respiratory Physiotherapy, State University of Londrina
state: Paraná
Study officials:
affiliation: State University of Londrina
name: Nidia A Hernandes, PhD
role: PRINCIPAL_INVESTIGATOR
References: