- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05218200
The Effect of Deep Breathing and Cough Exercise on Respiratory Parameters in Patients With Covid-19 Associated Pneumonia
The Effect of Deep Breathing and Cough Exercise on Pneumonia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Özge Uçar, RA
- Phone Number: +905458416296
- Email: ozgecan3112@hotmail.com
Study Contact Backup
- Name: Sibel Köstekli, PhD
- Phone Number: +905533017567
- Email: skostekli@bartin.edu.tr
Study Locations
-
-
-
Bartın, Turkey, 74100
- Recruiting
- Bartın University
-
Contact:
- Sevim Çelik, Proffessor
- Phone Number: 05458416296
- Email: scelik@bartin.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be over 18
- be conscious
- to know Turkish
- Not having any sensory or perceptual disability
- Being sick with Covid-19 pneumonia
- Volunteer
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
In addition to the routine care in the hospital, the patient will be given deep breathing and coughing exercises.
|
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.
|
|
No Intervention: Control group
There will be no intervention other than routine nursing care practices in the hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1st , 5th and 10th days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
respiratory parameters
Time Frame: 1st, 5th and 10nd days
|
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.
|
1st, 5th and 10nd days
|
|
effect on secretion
Time Frame: 1st, 5th and 10nd days
|
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
|
1st, 5th and 10nd days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Sevim ÇELİK, Prof., Bartin University Health Science Faculty
- Study Chair: Elif KARAHAN, Assoc. Prof., Bartin University Health Science Faculty
- Study Chair: Suna UZUN, Bartin State Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-FEN-A-016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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