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Completed

NCT Number: NCT04357340

The Effects of Pulmonary Physiotherapy Treatments on Patients With COVID-19

The aim of this study is to evaluate the efficacy of pulmonary physiotherapy on respiratory functions in hospitalized patients with Novel Coronavirus 2019 pneumonia. Patients will be randomized into 1) intervention group: receiving pulmonary physiotherapy technique to improve pulmonary function and walking training or 2) control group: Usual medical care. Patients in both groups will receive therapeutic incentive spirometer. Various outcome measurements of pulmonary functions will be evaluated before and after of interventions. Mortality rate, hospitalization duration and re-admission will be followed until one month after end of intervention. Also, patient's quality of life will be measured after one month.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imam Khomeini Hospital Complex

Tehran, Iran

About this study

In late December 2019, the new coronavirus (COVID-19) emerged in Wuhan, China and it has been confirmed as the cause of pneumonia in a large number of Chinese patients. The virus, also known as SARS-CoV-2, has since then spread to more than 200 countries worldwide.

The most common symptoms of COVID-19 are fever, dry cough, shortness of breath and tiredness. In severe cases, the infection could cause pneumonia, acute respiratory distress syndrome (ARDS) and sometimes leads to death. Pulmonary physiotherapy is a comprehensive, effective and safe treatment method which is aimed at improving patient's respiratory symptoms, train effective coughing, clear the airway secretion, eliminate exacerbation and so on. It seems that pulmonary physiotherapy interventions can effectively decrease hospitalization, reduce the risk of complications and improve the patient's medical condition.

The aim of this study is to evaluate the effectiveness of the hold breathing technique, chest expansion exercise, postural drainage procedure and Cough techniques carried out during pulmonary physiotherapy sessions.

The researchers will invite 40 hospitalized patients in Imam Khomeini Hospital Complex, Tehran, Iran. All patients will be enrolled after taking informed consent. All of the procedure will be performed with the coordination of the patient's physicians. Patients will be randomized to the intervention or control group. Primary outcome measurements will be evaluated immediately before and after the interventions (with three days period). Also, patient's condition (including process of disease progression, mortality, hospital stay duration and re-admission) will be followed until one month using medical records review and interviewing with the patient or his/her family. Patient's health related quality of life will be measured using short form-36 quality of life assessment tool one month after the end of interventions. Intention-to-treat analysis will be performed in the patients that dropped out of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with COVID-19 pneumonia confirmed by RT-PCR test and diagnostic radiology.
  • Non-intubated patients
  • Patients with full consciousness
  • Be able to walking and performing exercises.
  • O2 Saturation < 88% when free air breathing.
  • be able to write and read in Farsi

Exclusion criteria

  • Any type of musculoskeletal disorder disabling patient to participate to study.
  • Intubation during the period of intervention
  • Patients' dissatisfaction to continue the study for any reason.

Treatment and study plan

Pulmonary Physiotherapy Techniques

Other

Participants will receive pulmonary physiotherapy techniques in six session during three days (twice daily). Four distinguished interventions will be provided for the patients: 1) Chest expansion exercises (for prevention and treatment of potential atelectasis); 2) Techniques to Mobilize or loosen the pulmonary secretions (Active cycle breathing, Coughing techniques, Vibration and Postural drainage); 3) Hold breathing exercise (3 sets, 10 repetition) and; 4) Walking training (based on patient's tolerance until 6 minute).

Primary outcomes

  1. Mixed venous O2 pressure (PVO2)

    Time frame: Baseline

    Partial pressure of oxygen in mixed venous blood.

  2. Mixed venous O2 pressure (PVO2)

    Time frame: Day 3

    Partial pressure of oxygen in mixed venous blood.

  3. Mixed venous CO2 pressure (PVCO2)

    Time frame: Baseline

    Partial pressure of carbon dioxide in mixed venous blood.

  4. Mixed venous CO2 pressure (PVCO2)

    Time frame: Day 3

    Partial pressure of carbon dioxide in mixed venous blood.

  5. PH

    Time frame: Baseline

    Measure of the venous blood acidity or alkalinity

  6. PH

    Time frame: Day 3

    Measure of the venous blood acidity or alkalinity

  7. HCO3

    Time frame: Baseline

    The amount of bicarbonate ion in the venous blood

  8. HCO3

    Time frame: Day 3

    The amount of bicarbonate ion in the venous blood

  9. Oxygen saturation (O2 Sat) from VBG

    Time frame: Baseline

    The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood

  10. Oxygen saturation (O2 Sat) from VBG

    Time frame: Day 3

    The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood

  11. Three minute walk test

    Time frame: Baseline

    The distance a patient can walk during three minute

  12. Three minute walk test

    Time frame: Day 3

    The distance a patient can walk during three minute

  13. O2 Sat after one minute walking

    Time frame: Baseline

  14. O2 Sat after one minute walking

    Time frame: Day 3

  15. O2 Sat after two minutes use of Partial Rebreather

    Time frame: Baseline

  16. O2 Sat after two minutes use of Partial Rebreather

    Time frame: Day 3

  17. O2 Sat after two minutes free air breathing

    Time frame: Baseline

  18. O2 Sat after two minutes free air breathing

    Time frame: Day 3

  19. O2 sat/ Fio2

    Time frame: Baseline

  20. O2 sat/ Fio2

    Time frame: Day 3

Secondary outcomes

  1. Mortality rate

    Time frame: until one month

    The number of dead subjects compared to total patients

  2. Number of participants with Rehospitalization

    Time frame: until one moth

    Patients' hospitalization after discharge due to any reason

  3. The Health-Related Quality of Life (HRQOL)

    Time frame: One month after end of intervention

    Using Short-form 36 questionnaire. The minimum score is 0 and the maximum score is 100. Higher scores mean patient's better quality of life.

  4. breathlessness

    Time frame: Baseline

    The amount of shortness of breath using Visual Analogue Scale (VAS). The minimum score is 0 and maximum is 10. The 0 score means no breathlessness and the 10 score is the maximum breathlessness.

  5. breathlessness

    Time frame: Day 3

    The amount of shortness of breath using Visual Analogue Scale (VAS). The minimum score is 0 and maximum is 10. The 0 score means no breathlessness and the 10 score is the maximum breathlessness.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Efficacy of Pulmonary Physiotherapy on Hospitalized Patients With Novel Coronavirus 2019 Pneumonia

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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