Social Distancing During the COVID-19 Pandemic and People Living With Chronic Respiratory Diseases

NCT04693975 | Unknown

• 1 other identifier: PIDS-PC
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis; Asthma Chronic

Keywords

physical inactivity; sedentarism; chronic lung diseases

Outcome Measures

Primary Outcomes (2)

• Physical activity in daily life

  The totality of voluntary movement produced by skeletal muscles during everyday functioning will be assess by an activity monitor (ActiGraph) which will provide data of number of steps per day, and time spent in postures and activities of different intensities.

  24 months

• Patient's perception of physical activity in daily life

  The questionnaire PROactive Physical Activity in COPD, that measures the patients' percpetion of physical activities performed in daily living, will be used to complement the evaluation of physical activity level. It is composed by 12 items that evaluate difficulty in performing activities in daily life. Each item scores from 0 to 4; the total score is provided by summing all items and higher scores indicate higher physical activity level.

  24 months

Secondary Outcomes (8)

• Dyspnoea sensation in daily living

  24 months

• Acute exacerbation

  24 months

• Hospitalization

  24 months

• Functional status

  24 months

• Health-related Quality of life

  24 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects living with a chronic lung disease who are not infected with SARS-CoV-2.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

Study Sites (1)

Laboratory of Reasearch in Respiratory Physiotherapy, State University of Londrina

Londrina, Paraná, 86038-350, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis; Sedentary Behavior

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial; Behavior

Study Officials

• Nidia A Hernandes, PhD

  State University of Londrina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nidia A Hernandes, PhD

CONTACT

+55 43 3371 2477; nyhernandes@gmail.com

Fabio Pitta, PhD

CONTACT

+55 43 3371 2477; fabiopitta@uol.com.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 5, 2021
• Study Start: October 16, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)