EVALUATING THE EFFICIENCY OF BREATHING EXERCISES PERFORMED BY POST-COVID TELEMEDICINE: Randomized Controlled Study

Sponsor

Tokat Gaziosmanpasa University (Other)

Overall Status

Completed

CT.gov ID

NCT04771598

Collaborator

(none)

Enrollment

Location

Arms

5.1

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

As an important non-drug intervention in the treatment of respiratory tract diseases, respiratory rehabilitation training is increasingly accepted in clinical practice. The purpose of pulmonary rehabilitation is not only to improve the physical and mental conditions of the patient, but also to help the patient return to the family and society more quickly.

In light of the widely documented lung injuries associated with COVID-19, concerns are raised regarding the assessment of lung injury in discharged patients. As an important non-drug intervention in the treatment of respiratory diseases, respiratory rehabilitation training is increasingly being accepted in clinical practice The purpose of pulmonary rehabilitation is not only to improve the physical and mental conditions of the patient, but also to help the patient return to the family and society more quickly.

The aim of the study; It is aimed to evaluate the efficiency of breathing exercise in individuals with COVID-19.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: Breathing exercise with the phone application Other: Breathing exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised Controlled StudyRandomised Controlled Study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

EVALUATING THE EFFICIENCY OF BREATHING EXERCISES PERFORMED BY POST-COVID TELEMEDICINE: Randomized Controlled Study

Actual Study Start Date :

Feb 25, 2021

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: İntervention Respiratory exercises will be instructed to the individuals forming the intervention group and participants will be asked to do 3 times a day during one month and the exercises will be done by the researchers together with the individuals by establishing a connection with the phone application (zoom, watsapp) once a week from home. In terms of physical activity, the patient will be encouraged to participate in the program by suggesting exercises such as walking and cycling at least three times a week for 20 minutes per week	Other: Breathing exercise with the phone application Respiratory Control: Pursed Lip Breathing Diaphragmatic Breathing Respiratory exercises will be instructed to the individuals forming the intervention group and participants will be asked to do 3 times a day during one month and the exercises will be done by the researchers together with the individuals by establishing a connection with the phone application (zoom, watsapp) once a week from home.
Other: Control Breathing exercises will be explained to the control group and visual material will be given. The participants will be asked to do 3 times a day during one month. In terms of physical activity, the patient will be encouraged to participate in the program by suggesting exercises such as walking and cycling at least three times a week for 20 minutes per week	Other: Breathing exercise Respiratory Control: Pursed Lip Breathing Diaphragmatic Breathing Breathing exercises will be explained to the control group and visual material will be given. The participants will be asked to do 3 times a day during one month. In terms of physical activity, the patient will be encouraged to participate in the program by suggesting exercises such as walking and cycling at least three times a week for 20 minutes per week

Arm

Intervention/Treatment

Experimental: İntervention

Respiratory exercises will be instructed to the individuals forming the intervention group and participants will be asked to do 3 times a day during one month and the exercises will be done by the researchers together with the individuals by establishing a connection with the phone application (zoom, watsapp) once a week from home. In terms of physical activity, the patient will be encouraged to participate in the program by suggesting exercises such as walking and cycling at least three times a week for 20 minutes per week

Other: Breathing exercise with the phone application

Respiratory Control: Pursed Lip Breathing Diaphragmatic Breathing Respiratory exercises will be instructed to the individuals forming the intervention group and participants will be asked to do 3 times a day during one month and the exercises will be done by the researchers together with the individuals by establishing a connection with the phone application (zoom, watsapp) once a week from home.

Other: Control

Breathing exercises will be explained to the control group and visual material will be given. The participants will be asked to do 3 times a day during one month. In terms of physical activity, the patient will be encouraged to participate in the program by suggesting exercises such as walking and cycling at least three times a week for 20 minutes per week

Other: Breathing exercise

Respiratory Control: Pursed Lip Breathing Diaphragmatic Breathing Breathing exercises will be explained to the control group and visual material will be given. The participants will be asked to do 3 times a day during one month. In terms of physical activity, the patient will be encouraged to participate in the program by suggesting exercises such as walking and cycling at least three times a week for 20 minutes per week

Outcome Measures

Primary Outcome Measures

6 minute walking test [1 month]
6 minute walking test
FEV-1 [1 month]
FEV-1
FVC [1 month]
FVC
FEV1/FVC [1 month]
FEV1/FVC
MVV [1 month]
MVV- Maximal Voluntary Ventilation

Secondary Outcome Measures

St. George's Respiratory Questionnaire [1 month]
St. George's Respiratory Questionnaire-Scores range from 0 to 100, with higher scores indicating more limitations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older and who received / will receive treatment with the diagnosis of COVID 19 and completed 2 months after the diagnosis of COVID 19
Patients who applied to the Pulmonary Diseases outpatient clinic with complaints of dyspnea
FEV1 / FVC <80%, FVC <80%, FEV1 <80%, FEF25-75> 50% and / or Patients with respiratory distress in daily living activities

Exclusion Criteria:

FEV 1 <50%, FEF 25-75 <50% detected oxygen saturation <85% at rest,
moderately severe heart failure,
has a disease that restricts its mobilization,
psychiatric illness,
advanced stage liver, advanced stage renal failure,
Myocardial infarction within 4 months
having a history of unstable angina
active infectious disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tokat State Hospital	Tokat		Turkey

Sponsors and Collaborators

Tokat Gaziosmanpasa University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatih OKAN, Assist. Prof., Tokat Gaziosmanpasa University

ClinicalTrials.gov Identifier:

NCT04771598

Other Study ID Numbers:

123458

First Posted:

Feb 25, 2021

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 22, 2022