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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Sibel Köstekli, PhD contact

+905533017567

skostekli@bartin.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Bartın University

    Bartın, 74100

    Sevim Çelik, Proffessor, 05458416296, scelik@bartin.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05218200
Study groupRoleWhat they receive
experimental groupExperimentalIn 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 groupNo interventionThere 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted1 Feb 2022
  2. Study start15 Feb 2022
  3. Primary completion15 Dec 2022 (estimated)
  4. Study completion15 Feb 2023 (estimated)

Resources

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)
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

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.

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