NCT05218200

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

January 31, 2022

Last Update Submit

October 8, 2022

Conditions

Keywords

Covid-19pneumoniabreathing exercisecoughing exercise

Outcome Measures

Primary Outcomes (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.

    1st , 5th and 10th days

Secondary Outcomes (2)

  • respiratory parameters

    1st, 5th and 10nd days

  • effect on secretion

    1st, 5th and 10nd days

Study Arms (2)

experimental group

EXPERIMENTAL

In addition to the routine care in the hospital, the patient will be given deep breathing and coughing exercises.

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.

Interventions

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.

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be over 18
  • be conscious
  • to know Turkish
  • Not having any sensory or perceptual disability
  • Being sick with Covid-19 pneumonia
  • Volunteer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, 74100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Respiration DisordersCOVID-19Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung Diseases

Study Officials

  • Sevim ÇELİK, Prof.

    Bartin University Health Science Faculty

    STUDY DIRECTOR
  • Elif KARAHAN, Assoc. Prof.

    Bartin University Health Science Faculty

    STUDY CHAIR
  • Suna UZUN

    Bartin State Hospital

    STUDY CHAIR

Central Study Contacts

Sibel Köstekli, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The researcher collecting data does not know the characteristics of the groups.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: randomized controlled experimental research
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Bartın University

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 1, 2022

Study Start

February 15, 2022

Primary Completion

December 15, 2022

Study Completion

February 15, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations