Chronic Obstructive Pulmonary DiseaseNCT04693975
Social Distancing During the COVID-19 Pandemic and People Living With Chronic Respiratory Diseases
An observational study of Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Asthma Chronic
- How many people
- 94 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Oct 2020to Oct 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects living with a chronic lung disease who are not infected with SARS-CoV-2.
Who may be able to join
- 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.
Who cannot join
- Desire to leave the study at any time;
- Infection with SARS-CoV-2 during the study protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratory of Reasearch in Respiratory Physiotherapy, State University of Londrina
Londrina, Paraná, 86038-350
Nidia A Hernandes, PhD, +55 43 3371 2477, nyhernandes@gmail.com
Fabio Pitta, PhD, +55 43 3371 2477, fabiopitta@uol.com.br
About this study
Official title: Impact of Social Distancing During the COVID-19 Pandemic on Non-infected People With Chronic Respiratory Diseases
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).
Read more
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.
- Keywords
- physical inactivity, sedentarism, chronic lung diseases
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Sedentary Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Secondary outcomes (8)
Dyspnoea sensation in daily living
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.
Measured: 24 months
Acute exacerbation
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.
Measured: 24 months
Hospitalization
Hospital admission due to respiratory conditions. Occurrence of this event during the research protocol will be self-reported in the visits.
Measured: 24 months
Functional status
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.
Measured: 24 months
Health-related Quality of life
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.
Measured: 24 months
Health-related Quality of life
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.
Measured: 24 months
Sleep quality
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.
Measured: 24 months
Anxiety and depression
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start16 Oct 2020
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nídia A Hernandes, Universidade Estadual de Londrina
- Investigators
- Nidia A Hernandes, PhD, Principal investigator, State University of Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693975
- Sponsor's protocol ID
- PIDS-PC
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Social Distancing During the COVID-19 Pandemic on Non-infected People With Chronic Respiratory Diseases
- ClinicalTrials.gov ID
- NCT04693975
- Acronym / sponsor ID
- PIDS-PC
- Keywords
- physical inactivity, sedentarism, chronic lung diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects living with a chronic lung disease who are not infected with SARS-CoV-2.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Desire to leave the study at any time;
- Infection with SARS-CoV-2 during the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
8 secondary outcomes
Dyspnoea sensation in daily living
Time frame: 24 months
Acute exacerbation
Time frame: 24 months
Hospitalization
Time frame: 24 months
Functional status
Time frame: 24 months
Health-related Quality of life
Time frame: 24 months
Health-related Quality of life
Time frame: 24 months
Sleep quality
Time frame: 24 months
Anxiety and depression
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nidia A Hernandes, PhD principal investigator
State University of Londrina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis, run by Universidade Estadual de Londrina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nidia A Hernandes, PhD (+55 43 3371 2477, nyhernandes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity in daily life (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.