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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Iran, Islamic Republic of

Imam Khomeini Hospital Complex

Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

• Principal Investigator: Mohammad Javaherian, Ph.D. cand.; Tehran University of Medical Sciences

More Information

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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
• 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

• 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:

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