Pulmonary Rehabilitation in COVID-19 Patients

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04832867
Collaborator
(none)
300
Enrollment
1
Location
3.9
Anticipated Duration (Months)
76.1
Patients Per Site Per Month

Study Details

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 DiseaseIntervention/TreatmentPhase

    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
    Anticipated 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 :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2021
    Anticipated Study Completion Date :
    May 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. GLASKOW COMA SCALE [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 [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 [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) [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    SiteCityStateCountryPostal Code
    1Bakirkor Dr. Sadi Konuk Research and Training hospitalIstanbulTurkey34147

    Sponsors and Collaborators

    • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Apr 6, 2021
    Last Update Posted:
    Apr 6, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2021