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

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ClinicalTrials.gov Identifier: NCT04357340
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammad Javaherian, Tehran University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid-19 Pneumonia SARS Pneumonia Other: Pulmonary Physiotherapy Techniques Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All the enrolled participants will be allocated to the intervention of control groups using blocked-balanced randomization method.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pulmonary Physiotherapy on Hospitalized Patients With Novel Coronavirus 2019 Pneumonia
Actual Study Start Date : April 2, 2020
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Pulmonary Physiotherapy Techniques group
Pulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer.
Other: Pulmonary Physiotherapy Techniques
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).

No Intervention: Control group
Incentive spirometer only



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357340


Locations
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Iran, Islamic Republic of
Imam Khomeini Hospital Complex
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Mohammad Javaherian, Ph.D. cand. Tehran University of Medical Sciences
Publications:
Read JM, Bridgen JR, Cummings DA, Ho A, Jewell CP. Novel coronavirus 2019-nCoV: early estimation of epidemiological parameters and epidemic predictions. MedRxiv. 2020.
Liu T, Hu J, Kang M, Lin L, Zhong H, Xiao J, et al. Transmission dynamics of 2019 novel coronavirus (2019-nCoV). 2020.
Hillegass E. Essentials of Cardiopulmonary Physical Therapy-E-Book: Elsevier Health Sciences; 2016.

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Responsible Party: Mohammad Javaherian, PhD. Candidate of Phyiotherapy, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04357340    
Other Study ID Numbers: 99-1-103-47429
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underline the results reported in this article, after de-identification
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Beginning 3 months and ending 12 months following article publication
Access Criteria: Researchers who provide an approved methodologically proposal in the same purpose

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammad Javaherian, Tehran University of Medical Sciences:
Pulmonary Physiotherapy
2019 novel coronavirus disease
COVID-19
Rehabilitation
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections