Covid19NCT04771598
EVALUATING THE EFFICIENCY OF BREATHING EXERCISES PERFORMED BY POST-COVID TELEMEDICINE: Randomized Controlled Study
A study testing Breathing exercise with the phone application and Breathing exercise in people with Covid19, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Breathing exercise with the phone application and Breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2021to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Covid19
- Being tested
- Breathing exercise with the phone application, Breathing exercise
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercise with the phone applicationOther
- 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.
Breathing exerciseOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walking test
6 minute walking test
Measured: 1 month
FEV-1
FEV-1
Measured: 1 month
FVC
FVC
Measured: 1 month
FEV1/FVC
FEV1/FVC
Measured: 1 month
MVV
MVV- Maximal Voluntary Ventilation
Measured: 1 month
Secondary outcomes (1)
St. George's Respiratory Questionnaire
St. George's Respiratory Questionnaire-Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start25 Feb 2021
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Study
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih OKAN, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771598
- Sponsor's protocol ID
- 123458
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATING THE EFFICIENCY OF BREATHING EXERCISES PERFORMED BY POST-COVID TELEMEDICINE: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04771598
- Acronym / sponsor ID
- 123458
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Study
| Arm | Type | Receives |
|---|---|---|
| İntervention | Experimental | Other: Breathing exercise with the phone applicationRespiratory 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 |
| Control | Other | Other: Breathing exerciseBreathing 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exercise with the phone application1. 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. | Other | İntervention |
| Breathing exercise1. 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 | Other | Control |
Primary outcome
6 minute walking test
Time frame: 1 month
6 minute walking test
FEV-1
Time frame: 1 month
FEV-1
FVC
Time frame: 1 month
FVC
FEV1/FVC
Time frame: 1 month
FEV1/FVC
MVV
Time frame: 1 month
MVV- Maximal Voluntary Ventilation
1 secondary outcome
St. George's Respiratory Questionnaire
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise with the phone application and Breathing exercise in people with Covid19, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walking test (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.