Clinical trial NCT04832867: Pulmonary Rehabilitation in COVID-19 Patients
Official title: Pulmonary Rehabilitation in COVID-19 Patients: The Initial Results of Acute and Subacute Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients in Hospital's service

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.

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.

Eligibility 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

Primary outcomes:
measure: GLASKOW COMA SCALE
timeFrame: change from baseline glaskow coma scale at 1 months
measure: mMRC dyspnea scale
timeFrame: change from baseline at 1 month
Secondary outcomes:
measure: SpO2
timeFrame: change from baseline at 1 month
measure: carbon dioxide (CO2)
timeFrame: change from baseline at 1 month
measure: cardiac output test
timeFrame: change from baseline at 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkor Dr. Sadi Konuk Research and Training hospital
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: meltem vural
role: PRINCIPAL_INVESTIGATOR
References: