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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Breathing exercise with the phone application; Other: Breathing exercise

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey
    • Tokat State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walking test	6 minute walking test	1 month
FEV-1	FEV-1	1 month
FVC	FVC	1 month
FEV1/FVC	FEV1/FVC	1 month
MVV	MVV- Maximal Voluntary Ventilation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
St. George's Respiratory Questionnaire	St. George's Respiratory Questionnaire-Scores range from 0 to 100, with higher scores indicating more limitations.	1 month

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 5, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 123458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No