Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04357340
Other study ID # 99-1-103-47429
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2, 2020
Est. completion date May 30, 2020

Study information

Verified date May 2020
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Iran, Islamic Republic of Imam Khomeini Hospital Complex Tehran

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (17)

Ambrosino N, Makhabah DN. Comprehensive physiotherapy management in ARDS. Minerva Anestesiol. 2013 May;79(5):554-63. Epub 2013 Jan 10. Review. — View Citation

Bott J, Blumenthal S, Buxton M, Ellum S, Falconer C, Garrod R, Harvey A, Hughes T, Lincoln M, Mikelsons C, Potter C, Pryor J, Rimington L, Sinfield F, Thompson C, Vaughn P, White J; British Thoracic Society Physiotherapy Guideline Development Group. Guidelines for the physiotherapy management of the adult, medical, spontaneously breathing patient. Thorax. 2009 May;64 Suppl 1:i1-51. doi: 10.1136/thx.2008.110726. — View Citation

Chen J. Pathogenicity and transmissibility of 2019-nCoV-A quick overview and comparison with other emerging viruses. Microbes Infect. 2020 Mar;22(2):69-71. doi: 10.1016/j.micinf.2020.01.004. Epub 2020 Feb 4. — View Citation

Hillegass E. Essentials of Cardiopulmonary Physical Therapy-E-Book: Elsevier Health Sciences; 2016.

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:. — View Citation

Iriberri M, Gáldiz JB, Gorostiza A, Ansola P, Jaca C. Comparison of the distances covered during 3 and 6 min walking test. Respir Med. 2002 Oct;96(10):812-6. — View Citation

Jin X, Lian JS, Hu JH, Gao J, Zheng L, Zhang YM, Hao SR, Jia HY, Cai H, Zhang XL, Yu GD, Xu KJ, Wang XY, Gu JQ, Zhang SY, Ye CY, Jin CL, Lu YF, Yu X, Yu XP, Huang JR, Xu KL, Ni Q, Yu CB, Zhu B, Li YT, Liu J, Zhao H, Zhang X, Yu L, Guo YZ, Su JW, Tao JJ, Lang GJ, Wu XX, Wu WR, Qv TT, Xiang DR, Yi P, Shi D, Chen Y, Ren Y, Qiu YQ, Li LJ, Sheng J, Yang Y. Epidemiological, clinical and virological characteristics of 74 cases of coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut. 2020 Jun;69(6):1002-1009. doi: 10.1136/gutjnl-2020-320926. Epub 2020 Mar 24. — View Citation

Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29. — View Citation

Liu T, Hu J, Kang M, Lin L, Zhong H, Xiao J, et al. Transmission dynamics of 2019 novel coronavirus (2019-nCoV). 2020.

Munshi L, Kobayashi T, DeBacker J, Doobay R, Telesnicki T, Lo V, Cote N, Cypel M, Keshavjee S, Ferguson ND, Fan E. Intensive Care Physiotherapy during Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome. Ann Am Thorac Soc. 2017 Feb;14(2):246-253. doi: 10.1513/AnnalsATS.201606-484OC. — View Citation

Novoa N, Ballesteros E, Jiménez MF, Aranda JL, Varela G. Chest physiotherapy revisited: evaluation of its influence on the pulmonary morbidity after pulmonary resection. Eur J Cardiothorac Surg. 2011 Jul;40(1):130-4. doi: 10.1016/j.ejcts.2010.11.028. Epub 2011 Jan 11. — View Citation

Pan AM, Stiell IG, Clement CM, Acheson J, Aaron SD. Feasibility of a structured 3-minute walk test as a clinical decision tool for patients presenting to the emergency department with acute dyspnoea. Emerg Med J. 2009 Apr;26(4):278-82. doi: 10.1136/emj.2008.059774. — View Citation

Paulus F, Binnekade JM, Vroom MB, Schultz MJ. Benefits and risks of manual hyperinflation in intubated and mechanically ventilated intensive care unit patients: a systematic review. Crit Care. 2012 Aug 3;16(4):R145. doi: 10.1186/cc11457. Review. — View Citation

Read JM, Bridgen JR, Cummings DA, Ho A, Jewell CP. Novel coronavirus 2019-nCoV: early estimation of epidemiological parameters and epidemic predictions. MedRxiv. 2020.

Strickland SL, Rubin BK, Haas CF, Volsko TA, Drescher GS, O'Malley CA. AARC Clinical Practice Guideline: Effectiveness of Pharmacologic Airway Clearance Therapies in Hospitalized Patients. Respir Care. 2015 Jul;60(7):1071-7. doi: 10.4187/respcare.04165. — View Citation

Yang F, Liu N, Hu JY, Wu LL, Su GS, Zhong NS, Zheng ZG. [Pulmonary rehabilitation guidelines in the principle of 4S for patients infected with 2019 novel coronavirus (2019-nCoV)]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):180-182. doi: 10.3760/cma.j.issn.1001-0939.2020.03.007. Chinese. — View Citation

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Mixed venous O2 pressure (PVO2) Partial pressure of oxygen in mixed venous blood. Baseline
Primary Mixed venous O2 pressure (PVO2) Partial pressure of oxygen in mixed venous blood. Day 3
Primary Mixed venous CO2 pressure (PVCO2) Partial pressure of carbon dioxide in mixed venous blood. Baseline
Primary Mixed venous CO2 pressure (PVCO2) Partial pressure of carbon dioxide in mixed venous blood. Day 3
Primary PH Measure of the venous blood acidity or alkalinity Baseline
Primary PH Measure of the venous blood acidity or alkalinity Day 3
Primary HCO3 The amount of bicarbonate ion in the venous blood Baseline
Primary HCO3 The amount of bicarbonate ion in the venous blood Day 3
Primary Oxygen saturation (O2 Sat) from VBG The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood Baseline
Primary Oxygen saturation (O2 Sat) from VBG The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood Day 3
Primary Three minute walk test The distance a patient can walk during three minute Baseline
Primary Three minute walk test The distance a patient can walk during three minute Day 3
Primary O2 Sat after one minute walking Baseline
Primary O2 Sat after one minute walking Day 3
Primary O2 Sat after two minutes use of Partial Rebreather Baseline
Primary O2 Sat after two minutes use of Partial Rebreather Day 3
Primary O2 Sat after two minutes free air breathing Baseline
Primary O2 Sat after two minutes free air breathing Day 3
Primary O2 sat/ Fio2 Baseline
Primary O2 sat/ Fio2 Day 3
Secondary Mortality rate The number of dead subjects compared to total patients until one month
Secondary Number of participants with Rehospitalization Patients' hospitalization after discharge due to any reason until one moth
Secondary The Health-Related Quality of Life (HRQOL) 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. One month after end of intervention
Secondary breathlessness 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. Baseline
Secondary breathlessness 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. Day 3
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure