NCT04771598

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

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

February 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

February 21, 2021

Last Update Submit

February 5, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • St. George's Respiratory Questionnaire

    1 month

Study Arms (2)

İntervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

1. Respiratory Control: 2. Pursed Lip Breathing 3. 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.

İntervention

1. Respiratory Control: 2. Pursed Lip Breathing 3. 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

Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat State Hospital

Tokat Province, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 25, 2021

Study Start

February 25, 2021

Primary Completion

June 30, 2021

Study Completion

July 30, 2021

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations