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

• ClinicalTrials.gov Identifier: NCT04693975
• Recruitment Status: Recruiting
• First Posted: January 5, 2021
• Last Update Posted: January 5, 2021
• Sponsor: Universidade Estadual de Londrina
• Information provided by (Responsible Party): Nídia A Hernandes, Universidade Estadual de Londrina

Study Description

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.

Condition or disease
Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis; Asthma Chronic

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 94 participants
• Observational Model: Other
• Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Official Title: Impact of Social Distancing During the COVID-19 Pandemic on Non-infected People With Chronic Respiratory Diseases
• Actual Study Start Date: October 16, 2020
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: October 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Physical activity in daily life [ Time Frame: 24 months ]
   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.
2. Patient's perception of physical activity in daily life [ Time Frame: 24 months ]
   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.

Secondary Outcome Measures :

1. Dyspnoea sensation in daily living [ Time Frame: 24 months ]
   The Medical Research Council (MRC) scale will be used to assess limitation in activities of daily living due to dyspnoea sensation. The scale varies from 1 to 5 points; higher scores indicate higher limitation due to dyspnoea.
2. Acute exacerbation [ Time Frame: 24 months ]
   Acute exacerbations are episodes of acute worsening of the respiratory symptoms of patients with chronic lung disease, that result in additional therapy. Occurrence of those episodes during the research protocol will be self-reported in the visits.
3. Hospitalization [ Time Frame: 24 months ]
   Hospital admission due to respiratory conditions. Occurrence of this event during the research protocol will be self-reported in the visits.
4. Functional status [ Time Frame: 24 months ]
   Functional status is an individual's ability to perform normal daily activities required to meet basic needs, fulfill usual roles, and maintain health and well-being. The London Chest Activity of Daily Living (LCADL) scale, a validated tool to assess patients with chronic pulmonary disease, will be used to assess functional limitation. The scale is composed by 15 items divided in 4 domains; each item is scored from 0 to 5 points, indicating to what extent dyspnoea sensation limits functionality. The total score is calculated by summing all items; higher scores indicate worse functional status.
5. Health-related Quality of life [ Time Frame: 24 months ]
   Quality of life is a term used to refer to an individual's total well-being. An specific questionnaire, the Brazilian version of the Modified Saint George´s Respiratory Questionnaire (mSGRQ), will be used to assess those patients with COPD and asthma. It is composed by 50 items that evaluate limitation of quality of life due to respiratory symptoms; they are divided in 3 domains: symptoms, activity and impact. Patients' responses are "agree" or "do not agree". The total score is calculated by summing the 3 domains; higher scores indicate worse quality of life.
6. Health-related Quality of life [ Time Frame: 24 months ]
   Quality of life is a term used to refer to an individual's total well-being. An specific questionnaire, the Brazilian version of the Saint George´s Respiratory Questionnaire specifically developed for idiopathic pulmonary fibrosis patients (SGRQ-I), will be used to assess those patients with interstitial lung diseases. It is composed by 34 items that evaluate limitation of quality of life due to respiratory symptoms; they are divided in 3 domains: symptoms, activity and impact. The total score is calculated by summing the 3 domains varing from 0 to 100; higher scores indicate more impaired quality of life.
7. Sleep quality [ Time Frame: 24 months ]
   Sleep quality is defined as one's satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. The Pittsburgh Sleep Quality Index (PSQI) will be used to asssess sleep quality. It is composed by 19 item grouped into 7 components: sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, sleep medication use. Each of the sleep components yields a score ranging from 0 to 3; the total score is provided by summing all components, ranging from 0 to 21 points with the higher total score indicating worse sleep quality.
8. Anxiety and depression [ Time Frame: 24 months ]
   Presence of symptoms of anxiety and depression that the patients are experiencing will be assess by the Hospital Anxiety and Depression Scale (HADS). It is a 14-item scale with 7 items each for anxiety and depression subscales. Scoring for each item ranges from 0 to 3. A subscale score > 8 indicates anxiety or depression.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Contacts

Contact: Nidia A Hernandes, PhD; +55 43 3371 2477; nyhernandes@gmail.com

Contact: Fabio Pitta, PhD; +55 43 3371 2477; fabiopitta@uol.com.br

Locations

Brazil

Laboratory of Reasearch in Respiratory Physiotherapy, State University of Londrina; Recruiting

Londrina, Paraná, Brazil, 86038-350

Contact: Nidia A Hernandes, PhD +55 43 3371 2477 nyhernandes@gmail.com

Contact: Fabio Pitta, PhD +55 43 3371 2477 fabiopitta@uol.com.br

Sponsors and Collaborators

Universidade Estadual de Londrina

Investigators

• Principal Investigator: Nidia A Hernandes, PhD; State University of Londrina

More Information

• Responsible Party: Nídia A Hernandes, Principal Investigator, Universidade Estadual de Londrina
• ClinicalTrials.gov Identifier: NCT04693975
• Other Study ID Numbers: PIDS-PC
• First Posted: January 5, 2021
• Last Update Posted: January 5, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nídia A Hernandes, Universidade Estadual de Londrina:

physical inactivity; sedentarism; chronic lung diseases

Additional relevant MeSH terms:

COVID-19; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections