COVID-19 PneumoniaNCT05218200
The Effect of Deep Breathing and Cough Exercise on Respiratory Parameters in Patients With Covid-19 Associated Pneumonia
A study testing deep breathing and coughing exercises with triflo in people with COVID-19 Pneumonia and Respiratory Disease, run by Özge Uçar at 1 site in Turkey (Türkiye).
Trial summary
Studies reveal that the Covid-19 virus can be transmitted in three ways: respiratory tract, direct contact and feces. The incubation period is estimated to be 5.2 [4.1-7.0] days for the 95% confidence interval and the virus transmission coefficient (R0) baseline growth number is 2.2 [1.4-3.9]. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia, Respiratory Disease
- What is being tested?
- deep breathing and coughing exercises with triflo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 Feb 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be over 18
- be conscious
- to know Turkish
- Not having any sensory or perceptual disability
- Being sick with Covid-19 pneumonia
- Volunteer
Who cannot join
- be under the age of 18
- not being conscious
- Not knowing Turkish
- Presence of any sensory or perceptual disability
- Not having covid-19 pneumonia
- Receiving mechanical ventilation support
- not volunteering
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartın University
Bartın, 74100
Sevim Çelik, Proffessor, 05458416296, scelik@bartin.edu.tr
About this study
Official title: The Effect of Deep Breathing and Cough Exercise on Pneumonia
Studies reveal that the Covid-19 virus can be transmitted in three ways: respiratory tract, direct contact and feces. The incubation period is estimated to be 5.2 [4.1-7.0] days for the 95% confidence interval and the virus transmission coefficient (R0) baseline growth number is 2.2 [1.4-3.9]. The main signs and symptoms described in the literature are; other atypical symptoms, particularly fever (98%), cough (76%), myalgia or fatigue (44%); sputum (28%), headache (8%), hemoptysis (5%), vomiting (5%), diarrhea (3%) and shortness of breath were detected. In addition to lymphopenia, which is detected in 63% of cases, pneumonia is also present. Widely regarded as the cornerstone of pulmonary rehabilitation, exercise training is the best way to improve muscle function in COPD and other chronic respiratory diseases. After 326 patients hospitalized in the pandemic clinical services of a public hospital were randomly divided into the experimental (n=168) and control groups (n=168), the effect of the experiment on the respiratory parameters of the experiment will be monitored without any intervention in the control group, while deep breathing and coughing exercises will be applied to the experimental group. The aim of this study is to determine the effect of deep breathing and coughing exercises on respiratory parameters in patients treated for pneumonia due to COVID-19 disease.
Read the detailed description
A new virus called SARS-CoV-2 was detected on January 7, 2020, due to the investigations carried out in the city of Wuhan, Hubei province of China, in December 2019, in 27 pneumonia cases unknown cause. The World Health Organization (WHO) declared on January 30, 2020, that it is facing a virus that threatens public health, and it was reported a pandemic on March 11, 2020.
Studies show that the virus can be transmitted in three ways: respiratory tract, direct contact, and feces.
The main signs and symptoms described in the literature are; other atypical symptoms, particularly fever (98%), cough (76%), myalgia or fatigue (44%); dyspnea (55%), sputum (28%), headache (8%), hemoptysis (5%), vomiting (5%) and diarrhea (3%). In addition to lymphopenia, which was detected in 63% of cases, all patients had pneumonia. Complications included acute respiratory distress syndrome (29%), acute heart injury (12%), and secondary infections (10%). Other more striking symptoms, such as chemosensory dysfunction, have also been described. Most of the patients diagnosed with COVID-19 have at least one underlying chronic disease (such as hypertension and chronic obstructive pulmonary disease). Many of these patients have to be treated in intensive care units (ICU). It is estimated that 80% of patients will present with mild symptoms that can be followed up without hospitalization. It is foreseen that the remaining 20% may need clinical medical care, and 5% of this may need to be hospitalized in the intensive care unit. The mean time from onset of symptoms to recovery is two weeks in patients with mild symptoms, but 3-6 weeks in patients with the severe or critical disease.
The international consensus on managing patients with Covid-19-associated acute respiratory distress syndrome (ARDS) is that despite the increasing number of reports on respiratory system mechanics and ventilation management, more experimental studies are needed. Death cases due to Covid-19 are thought to be caused mainly by ARDS. Although the incidence of ARDS reported among all Covid-19 patients is 15.6-31%, it is higher than other organ damage rates. With the increase in the number of Covid-19 patients hospitalized recently, different management strategies have started to be needed by healthcare professionals to save the lives of patients with ARDS.
In the literature, research on the pathophysiology of Covid-19 is still limited. However, evidence-based laboratory findings and clinical-pathological characteristics of Covid-19 patients suggest that secretion of large amounts of mucus in the airway interferes with the ventilation and alveolar formation process, and interstitial changes are the mechanisms underlying the impairment of gas exchange. Studies have reported that the duration of ARDS development in Covid-19 patients is between 8-12 days on average after the first symptoms are seen. Corticosteroid therapy and high-flow nasal oxygen therapy are frequently used in patients who develop ARDS. ARDS is shown as the most common cause of mortality in Covid-19 patients. Widely regarded as the cornerstone of pulmonary rehabilitation, exercise training is the best way to improve muscle function in COPD and other chronic respiratory diseases. It is indicated for patients with reduced exercise tolerance, exercise dyspnea or fatigue, impaired daily living activities, and chronic respiratory disease.
In line with these data, it is thought that specific deep breathing and coughing exercises may be beneficial to reduce reversible pulmonary changes such as secretions and interstitial fluid accumulation, maximize the area of the alveolar sacs, and accelerate the secretion clearance process.
- Conditions
- COVID-19 Pneumonia, Respiratory Disease
- Being tested
- deep breathing and coughing exercises with triflo
- Keywords
- Covid-19, pneumonia, breathing exercise, coughing exercise
- Medical subject headings
- Respiration Disorders, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep breathing and coughing exercises with trifloOther
patients will be given triflo. A video of the application of deep breathing and coughing exercises with triflo prepared by the researchers will be prepared. The video will be sent to the patients' phones. It will be ensured that the patients do the exercises every hour by watching the video and they will be followed.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | In addition to the routine care in the hospital, the patient will be given deep breathing and coughing exercises. Receives: Other: deep breathing and coughing exercises with triflo |
| Control group | No intervention | There will be no intervention other than routine nursing care practices in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the severity of dyspnea
The effect of breathing and coughing exercises with triflo on dyspnea in patients with Covid-19 pneumonia using by Dispne-12 scale.
Measured: 1st , 5th and 10th days
Secondary outcomes (2)
respiratory parameters
The effect of deep breathing and coughing exercises with triflo on respiratory parameters in patients with Covid-19 pneumonia by using blood gas analysis result.
Measured: 1st, 5th and 10nd days
effect on secretion
The effect of deep breathing and coughing exercises with triflo on amount of secretion in patients with Covid-19 pneumonia by using secretion measuring cup
Measured: 1st, 5th and 10nd days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start15 Feb 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized controlled experimental research
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Özge Uçar
- Sponsor type
- University, hospital or other
- Collaborators
- Bartin State Hospital
- Responsible party
- Sponsor-investigator, Özge Uçar, Bartın Unıversity
- Investigators
- Sevim ÇELİK, Prof., Study director, Bartin University Health Science FacultyElif KARAHAN, Assoc. Prof., Study chair, Bartin University Health Science FacultySuna UZUN, Study chair, Bartin State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218200
- Sponsor's protocol ID
- 2021-FEN-A-016
- Status last verified
- Oct 2022
- First submitted
- 31 Jan 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Breathing and Cough Exercise on Pneumonia
- ClinicalTrials.gov ID
- NCT05218200
- Acronym / sponsor ID
- 2021-FEN-A-016
- Conditions
- COVID-19 Pneumonia, Respiratory Disease
- Keywords
- Covid-19, pneumonia, breathing exercise, coughing exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Özge UçarUniversity, hospital or other
- Collaborators
- Bartin State Hospital
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 1 Feb 2022 (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.
Studies reveal that the Covid-19 virus can be transmitted in three ways: respiratory tract, direct contact and feces. The incubation period is estimated to be 5.2 [4.1-7.0] days for the 95% confidence interval and the virus transmission coefficient (R0) baseline growth number is 2.2 [1.4-3.9]. The main signs and symptoms described in the literature are; other atypical symptoms, particularly fever (98%), cough (76%), myalgia or fatigue (44%); sputum (28%), headache (8%), hemoptysis (5%), vomiting (5%), diarrhea (3%) and shortness of breath were detected. In addition to lymphopenia, which is detected in 63% of cases, pneumonia is also present. Widely regarded as the cornerstone of pulmonary rehabilitation, exercise training is the best way to improve muscle function in COPD and other chronic respiratory diseases. After 326 patients hospitalized in the pandemic clinical services of a public hospital were randomly divided into the experimental (n=168) and control groups (n=168), the effect of the experiment on the respiratory parameters of the experiment will be monitored without any intervention in the control group, while deep breathing and coughing exercises will be applied to the experimental group. The aim of this study is to determine the effect of deep breathing and coughing exercises on respiratory parameters in patients treated for pneumonia due to COVID-19 disease.
Detailed description
A new virus called SARS-CoV-2 was detected on January 7, 2020, due to the investigations carried out in the city of Wuhan, Hubei province of China, in December 2019, in 27 pneumonia cases unknown cause. The World Health Organization (WHO) declared on January 30, 2020, that it is facing a virus that threatens public health, and it was reported a pandemic on March 11, 2020.
Studies show that the virus can be transmitted in three ways: respiratory tract, direct contact, and feces.
The main signs and symptoms described in the literature are; other atypical symptoms, particularly fever (98%), cough (76%), myalgia or fatigue (44%); dyspnea (55%), sputum (28%), headache (8%), hemoptysis (5%), vomiting (5%) and diarrhea (3%). In addition to lymphopenia, which was detected in 63% of cases, all patients had pneumonia. Complications included acute respiratory distress syndrome (29%), acute heart injury (12%), and secondary infections (10%). Other more striking symptoms, such as chemosensory dysfunction, have also been described. Most of the patients diagnosed with COVID-19 have at least one underlying chronic disease (such as hypertension and chronic obstructive pulmonary disease). Many of these patients have to be treated in intensive care units (ICU). It is estimated that 80% of patients will present with mild symptoms that can be followed up without hospitalization. It is foreseen that the remaining 20% may need clinical medical care, and 5% of this may need to be hospitalized in the intensive care unit. The mean time from onset of symptoms to recovery is two weeks in patients with mild symptoms, but 3-6 weeks in patients with the severe or critical disease.
The international consensus on managing patients with Covid-19-associated acute respiratory distress syndrome (ARDS) is that despite the increasing number of reports on respiratory system mechanics and ventilation management, more experimental studies are needed. Death cases due to Covid-19 are thought to be caused mainly by ARDS. Although the incidence of ARDS reported among all Covid-19 patients is 15.6-31%, it is higher than other organ damage rates. With the increase in the number of Covid-19 patients hospitalized recently, different management strategies have started to be needed by healthcare professionals to save the lives of patients with ARDS.
In the literature, research on the pathophysiology of Covid-19 is still limited. However, evidence-based laboratory findings and clinical-pathological characteristics of Covid-19 patients suggest that secretion of large amounts of mucus in the airway interferes with the ventilation and alveolar formation process, and interstitial changes are the mechanisms underlying the impairment of gas exchange. Studies have reported that the duration of ARDS development in Covid-19 patients is between 8-12 days on average after the first symptoms are seen. Corticosteroid therapy and high-flow nasal oxygen therapy are frequently used in patients who develop ARDS. ARDS is shown as the most common cause of mortality in Covid-19 patients. Widely regarded as the cornerstone of pulmonary rehabilitation, exercise training is the best way to improve muscle function in COPD and other chronic respiratory diseases. It is indicated for patients with reduced exercise tolerance, exercise dyspnea or fatigue, impaired daily living activities, and chronic respiratory disease.
In line with these data, it is thought that specific deep breathing and coughing exercises may be beneficial to reduce reversible pulmonary changes such as secretions and interstitial fluid accumulation, maximize the area of the alveolar sacs, and accelerate the secretion clearance process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized controlled experimental research
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: deep breathing and coughing exercises with trifloIn addition to the routine care in the hospital, the patient will be given deep breathing and coughing exercises. |
| Control group | No intervention | –There will be no intervention other than routine nursing care practices in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be over 18
- be conscious
- to know Turkish
- Not having any sensory or perceptual disability
- Being sick with Covid-19 pneumonia
Key exclusion criteria (7 listed)
- be under the age of 18
- not being conscious
- Not knowing Turkish
- Presence of any sensory or perceptual disability
- Not having covid-19 pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep breathing and coughing exercises with triflopatients will be given triflo. A video of the application of deep breathing and coughing exercises with triflo prepared by the researchers will be prepared. The video will be sent to the patients' phones. It will be ensured that the patients do the exercises every hour by watching the video and they will be followed. | Other | experimental group |
Primary outcome
measuring the severity of dyspnea
Time frame: 1st , 5th and 10th days
The effect of breathing and coughing exercises with triflo on dyspnea in patients with Covid-19 pneumonia using by Dispne-12 scale.
2 secondary outcomes
respiratory parameters
Time frame: 1st, 5th and 10nd days
effect on secretion
Time frame: 1st, 5th and 10nd days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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.
Sevim ÇELİK, Prof. study director
Bartin University Health Science Faculty
Elif KARAHAN, Assoc. Prof. study chair
Bartin University Health Science Faculty
Suna UZUN study chair
Bartin State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep breathing and coughing exercises with triflo in people with COVID-19 Pneumonia and Respiratory Disease, run by Özge Uçar at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 13 Oct 2022. 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 Turkey (Türkiye). 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 Özge Uçar, RA (+905458416296, ozgecan3112@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring the severity of dyspnea (time frame: 1st , 5th and 10th days). 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 13 Oct 2022.