Pulmonary Rehabilitation in COVID-19 Patients

• ClinicalTrials.gov Identifier: NCT04832867
• Recruitment Status: Recruiting
• First Posted: April 6, 2021
• Last Update Posted: April 6, 2021
• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Information provided by (Responsible Party): Meltem Vural, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Description

Brief 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.

Condition or disease
Covid19

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

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Pulmonary Rehabilitation in COVID-19 Patients: The Initial Results of Acute and Subacute Rehabilitation
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: April 1, 2021
• Estimated Study Completion Date: May 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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).

Secondary Outcome Measures :

1. SpO2 [ Time Frame: change from baseline at 1 month ]
   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.
2. carbon dioxide (CO2) [ Time Frame: change from baseline at 1 month ]
   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.
3. cardiac output test [ Time Frame: change from baseline at 1 month ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

patients in Hospital's service

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: meltem vural; +905337434411; drmeltemvural@gmail.com

Contact: sibel çağlar; +905333365651; sibelcaglarokur@gmail.com

Locations

Turkey

Bakirkor Dr. Sadi Konuk Research and Training hospital; Recruiting

Istanbul, Turkey, 34147

Contact: meltem vural +905337434411 drmeltemvural@gmail.com

Sponsors and Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

• Principal Investigator: meltem vural; Bakırkoy Dr. Sadi Konuk Training and Research Hospital

More Information

• Responsible Party: Meltem Vural, principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT04832867
• Other Study ID Numbers: Pulmonary rehabilitation
• First Posted: April 6, 2021
• Last Update Posted: April 6, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases