Covid19NCT04832867
Pulmonary Rehabilitation in COVID-19 Patients
An observational study of Covid19, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to evaluate the respiratory functions of patients who were given respiratory rehabilitation, bed positioning and early mobilization, and the time of leaving the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 May 2021
- Phase
- Observational
- 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
Study population: patients in Hospital's service
Who may be able to join
- Being over 18 years old
- Those who have been hospitalized since 11.01.2020
- Those who have been consulted to the physical therapy clinic since 11.01.2020
Who cannot join
- Fever ˃38.0 °
- Initial consultation time ˂7 days
- In those with 3 days from the onset of the disease to shortness of breath Chest radiographic scans showing 50% progression within 24 to 48 hours
- With Spo2 level ≤95%
- Resting blood pressure ˂90 / 60 (1mmHg = 0.133kPa) or ˃140 / 90mmHg. 100 heart rate per minute Those with moderate and / or severe heart disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkor Dr. Sadi Konuk Research and Training hospital
Istanbul, 34147
meltem vural, +905337434411, drmeltemvural@gmail.com
About this study
Official title: Pulmonary Rehabilitation in COVID-19 Patients: The Initial Results of Acute and Subacute Rehabilitation
It was aimed to evaluate the respiratory functions of patients who were given respiratory rehabilitation, bed positioning and early mobilization, and the time of leaving the hospital.
Read the detailed description
According to the clinical classification of the World Health Organization, COVID-19; It manifests itself in a wide spectrum, ranging from mild illness, Pneumonia, Severe pneumonia, Acute respiratory distress syndrome (ARDS), to Sepsis and septic shock, resulting in death. In the presence of acute respiratory failure, a decrease in lung compliance leads to increased respiratory work, impaired blood oxygenation, and rapid and superficial breathing patterns. In this case, minimizing inspiratory effort and maximizing the mechanical efficiency of breathing is the most important approach of treatment. In these clinical conditions, the strength of the respiratory muscles may also be reduced.
The challenge of COVID-19 requires a multidisciplinary approach. Rehabilitative intervention should be a part of the treatment pathway from the early stages of the disease. There is an urgent need to build information based on the most effective non-pharmacological measures to ensure the earliest discharge and best recovery after complex COVID-19 infection. Multimodal rehabilitation at all stages of the disease should be part of a holistic medical approach, but there is still no consensus on the timing and type of intervention.
According to the clinical classification of COVID-19 disease, especially according to the WHO clinical classification, 2.-4. The respiratory system is significantly affected during the stages. In addition, after the active phase of the disease, it is not clear how much damage or sequelae will remain in patients, as there is not enough information about the long-term consequences. In the appropriate patient, pulmonary rehabilitation interventions at the appropriate time will definitely be required.
The aims of pulmonary rehabilitation in general are:
- To keep the respiratory tract open; To reduce respiratory tract resistance and improve ventilation by preventing secretion accumulation with positioning, mobilization, effective cough and other secretion drainage methods, The diaphragm and other respiratory muscles in a more normal position and function. to ensure that With a breathing pattern that improves the respiratory task and reduces air entrapment reducing the respiratory rate,
- To reduce respiratory work / burden and energy consumption during breathing with appropriate training,
- To prevent or increase chest mobility with exercises suitable for the individual, to detect postural deformities in the musculoskeletal system due to lung disorders, to prevent and / or correct deformity development with appropriate exercise prescription,
- To reduce dyspnea and to relax,
- To improve endurance and general exercise tolerance,
- Suppressing anxiety, depression and anxiety,
- To improve the loss of function and quality of life.
Pulmonary rehabilitation consists of the following items in scope:
Exercise training; respiratory and physical exercise training and breathing strategies
- Work and occupation therapy
- Patient education and smoking cessation
- Nutritional assessment and support
- Psychosocial support
- Long-term oxygen therapy
- Use of non-invasive and invasive mechanical ventilation
Exercise training in pulmonary rehabilitation; It is the most important and obligatory one among the PR elements, it can be thought that it will be the most effective in meeting the PR objectives.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
GLASKOW COMA SCALE
The scale was described in 1974 by Graham tesdale and Bryan Jenett as a way to communicate of patients with an acute brain injury. A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive). This score is used to guide immediate medical care after a brain injury (such as a car accident) and also to monitor hospitalized patients and track their level of consciousness.
The glasgow coma scale is often used to help define the severity of TBI. Mild head injuries are generally defined as those associated with a glasgow coma scale score of 13-15, and moderate head injuries are those associated with a glasgow coma scale score of 9-12. A glasgow coma scale score of 8 or less defines a severe head injury.
Measured: change from baseline glaskow coma scale at 1 months
mMRC dyspnea scale
THe mMRC dsypnea scale quantifies disability attributable to breathlessness and is useful for charecterizing baseline dyspnea in patients with respiratory disease. describes baseline dyspnea but does not accurately quantify response to treatment of chornic obstructive pulmonary disease (COPD).
Measured: change from baseline at 1 month
Secondary outcomes (3)
SpO2
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. The human body requires and regulates a very precise and specific balance of oxygen in the blood. Normal arterial blood oxygen saturation levels in humans are 95-100 percent.
Measured: change from baseline at 1 month
carbon dioxide (CO2)
The normal range for CO2 is 23 to 29 mEq/L (milliequivalent units per liter of blood). The blood test often measures blood pH along with CO2 levels to further determine the cause of your symptoms. Blood pH is a measurement of acidity or alkalinity.
Measured: change from baseline at 1 month
cardiac output test
Cardiac output (CO), also known as heart output denoted by the symbols {\displaystyle Q}Q, or {\displaystyle {\dot {Q}}_{c}}{\dot Q}_{{c}},[2] is a term used in cardiac physiology that describes the volume of blood being pumped by the heart, by the left and right ventricle, per unit time. Cardiac output (CO) is the product of the heart rate (HR), i.e. the number of heartbeats per minute (bpm), and the stroke volume (SV), which is the volume of blood pumped from the ventricle per beat; thus, CO = HR × SV.[3] Values for cardiac output are usually denoted as L/min. For a healthy person weighing 70 kg, the cardiac output at rest averages about 5 L/min; assuming a heart rate of 70 beats/min, the stroke volume would be approximately 70 ml.
Measured: change from baseline at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Jan 2021
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Meltem Vural, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- meltem vural, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832867
- Sponsor's protocol ID
- Pulmonary rehabilitation
- Status last verified
- Apr 2021
- First submitted
- 27 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation in COVID-19 Patients: The Initial Results of Acute and Subacute Rehabilitation
- ClinicalTrials.gov ID
- NCT04832867
- Acronym / sponsor ID
- Pulmonary rehabilitation
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 6 Apr 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.
It was aimed to evaluate the respiratory functions of patients who were given respiratory rehabilitation, bed positioning and early mobilization, and the time of leaving the hospital.
Detailed description
According to the clinical classification of the World Health Organization, COVID-19; It manifests itself in a wide spectrum, ranging from mild illness, Pneumonia, Severe pneumonia, Acute respiratory distress syndrome (ARDS), to Sepsis and septic shock, resulting in death. In the presence of acute respiratory failure, a decrease in lung compliance leads to increased respiratory work, impaired blood oxygenation, and rapid and superficial breathing patterns. In this case, minimizing inspiratory effort and maximizing the mechanical efficiency of breathing is the most important approach of treatment. In these clinical conditions, the strength of the respiratory muscles may also be reduced.
The challenge of COVID-19 requires a multidisciplinary approach. Rehabilitative intervention should be a part of the treatment pathway from the early stages of the disease. There is an urgent need to build information based on the most effective non-pharmacological measures to ensure the earliest discharge and best recovery after complex COVID-19 infection. Multimodal rehabilitation at all stages of the disease should be part of a holistic medical approach, but there is still no consensus on the timing and type of intervention.
According to the clinical classification of COVID-19 disease, especially according to the WHO clinical classification, 2.-4. The respiratory system is significantly affected during the stages. In addition, after the active phase of the disease, it is not clear how much damage or sequelae will remain in patients, as there is not enough information about the long-term consequences. In the appropriate patient, pulmonary rehabilitation interventions at the appropriate time will definitely be required.
The aims of pulmonary rehabilitation in general are:
- To keep the respiratory tract open; To reduce respiratory tract resistance and improve ventilation by preventing secretion accumulation with positioning, mobilization, effective cough and other secretion drainage methods, The diaphragm and other respiratory muscles in a more normal position and function. to ensure that With a breathing pattern that improves the respiratory task and reduces air entrapment reducing the respiratory rate,
- To reduce respiratory work / burden and energy consumption during breathing with appropriate training,
- To prevent or increase chest mobility with exercises suitable for the individual, to detect postural deformities in the musculoskeletal system due to lung disorders, to prevent and / or correct deformity development with appropriate exercise prescription,
- To reduce dyspnea and to relax,
- To improve endurance and general exercise tolerance,
- Suppressing anxiety, depression and anxiety,
- To improve the loss of function and quality of life.
Pulmonary rehabilitation consists of the following items in scope:
Exercise training; respiratory and physical exercise training and breathing strategies
- Work and occupation therapy
- Patient education and smoking cessation
- Nutritional assessment and support
- Psychosocial support
- Long-term oxygen therapy
- Use of non-invasive and invasive mechanical ventilation
Exercise training in pulmonary rehabilitation; It is the most important and obligatory one among the PR elements, it can be thought that it will be the most effective in meeting the PR objectives.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in Hospital's service
Key inclusion criteria (3 listed)
- Being over 18 years old
- Those who have been hospitalized since 11.01.2020
- Those who have been consulted to the physical therapy clinic since 11.01.2020
Key exclusion criteria (5 listed)
- Fever ˃38.0 °
- Initial consultation time ˂7 days
- In those with 3 days from the onset of the disease to shortness of breath Chest radiographic scans showing 50% progression within 24 to 48 hours
- With Spo2 level ≤95%
- Resting blood pressure ˂90 / 60 (1mmHg = 0.133kPa) or ˃140 / 90mmHg. 100 heart rate per minute Those with moderate and / or severe heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GLASKOW COMA SCALE
Time frame: change from baseline glaskow coma scale at 1 months
The scale was described in 1974 by Graham tesdale and Bryan Jenett as a way to communicate of patients with an acute brain injury. A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive). This score is used to guide immediate medical care after a brain injury (such as a car accident) and also to monitor hospitalized patients and track their level of consciousness. The glasgow coma scale is often used to help define the severity of TBI. Mild head injuries are generally defined as those associated with a glasgow coma scale score of 13-15, and moderate head injuries are those associated with a glasgow coma scale score of 9-12. A glasgow coma scale score of 8 or less defines a severe head injury.
mMRC dyspnea scale
Time frame: change from baseline at 1 month
THe mMRC dsypnea scale quantifies disability attributable to breathlessness and is useful for charecterizing baseline dyspnea in patients with respiratory disease. describes baseline dyspnea but does not accurately quantify response to treatment of chornic obstructive pulmonary disease (COPD).
3 secondary outcomes
SpO2
Time frame: change from baseline at 1 month
carbon dioxide (CO2)
Time frame: change from baseline at 1 month
cardiac output test
Time frame: change from baseline at 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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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.
meltem vural principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact meltem vural (+905337434411, drmeltemvural@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLASKOW COMA SCALE (time frame: change from baseline glaskow coma scale at 1 months). The study lists 2 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 6 Apr 2021.