The Effect of Deep Breathing and Cough Exercise on Respiratory Parameters in Patients With Covid-19 Associated Pneumonia
Primary Purpose
COVID-19 Pneumonia, Respiratory Disease
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
deep breathing and coughing exercises with triflo
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19 Pneumonia focused on measuring Covid-19, pneumonia, breathing exercise, coughing exercise
Eligibility Criteria
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
Sites / Locations
- Bartın UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
Control group
Arm Description
In addition to the routine care in the hospital, the patient will be given deep breathing and coughing exercises.
There will be no intervention other than routine nursing care practices in the hospital.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT05218200
First Posted
January 31, 2022
Last Updated
October 8, 2022
Sponsor
Özge Uçar
Collaborators
Bartin State Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05218200
Brief Title
The Effect of Deep Breathing and Cough Exercise on Respiratory Parameters in Patients With Covid-19 Associated Pneumonia
Official Title
The Effect of Deep Breathing and Cough Exercise on Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
February 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Özge Uçar
Collaborators
Bartin State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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]. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia, Respiratory Disease
Keywords
Covid-19, pneumonia, breathing exercise, coughing exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized controlled experimental research
Masking
Investigator
Masking Description
The researcher collecting data does not know the characteristics of the groups.
Allocation
Randomized
Enrollment
326 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
In addition to the routine care in the hospital, the patient will be given deep breathing and coughing exercises.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
There will be no intervention other than routine nursing care practices in the hospital.
Intervention Type
Other
Intervention Name(s)
deep breathing and coughing exercises with triflo
Intervention Description
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.
Primary Outcome Measure Information:
Title
measuring the severity of dyspnea
Description
The effect of breathing and coughing exercises with triflo on dyspnea in patients with Covid-19 pneumonia using by Dispne-12 scale.
Time Frame
1st , 5th and 10th days
Secondary Outcome Measure Information:
Title
respiratory parameters
Description
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.
Time Frame
1st, 5th and 10nd days
Title
effect on secretion
Description
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
Time Frame
1st, 5th and 10nd days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özge Uçar, RA
Phone
+905458416296
Email
ozgecan3112@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sibel Köstekli, PhD
Phone
+905533017567
Email
skostekli@bartin.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevim ÇELİK, Prof.
Organizational Affiliation
Bartin University Health Science Faculty
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elif KARAHAN, Assoc. Prof.
Organizational Affiliation
Bartin University Health Science Faculty
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Suna UZUN
Organizational Affiliation
Bartin State Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bartın University
City
Bartın
ZIP/Postal Code
74100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sevim Çelik, Proffessor
Phone
05458416296
Email
scelik@bartin.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Deep Breathing and Cough Exercise on Respiratory Parameters in Patients With Covid-19 Associated Pneumonia
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