Covid-19NCT04357340
The Effects of Pulmonary Physiotherapy Treatments on Patients With COVID-19
A study testing Pulmonary Physiotherapy Techniques in people with Covid-19 and Pneumonia, run by Tehran University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid-19, Pneumonia, SARS Pneumonia
- What is being tested?
- Pulmonary Physiotherapy Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 2 Apr 2020to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pulmonary Physiotherapy on Hospitalized Patients With Novel Coronavirus 2019 Pneumonia
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.
Read the 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.
- Conditions
- Covid-19, Pneumonia, SARS Pneumonia
- Being tested
- Pulmonary Physiotherapy Techniques
- Keywords
- Pulmonary Physiotherapy, 2019 novel coronavirus disease, COVID-19, Rehabilitation
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Physiotherapy TechniquesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Physiotherapy Techniques group | Experimental | Pulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer. Receives: Other: Pulmonary Physiotherapy Techniques |
| Control group | No intervention | Incentive spirometer only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mixed venous O2 pressure (PVO2)
Partial pressure of oxygen in mixed venous blood.
Measured: Baseline
Mixed venous O2 pressure (PVO2)
Partial pressure of oxygen in mixed venous blood.
Measured: Day 3
Mixed venous CO2 pressure (PVCO2)
Partial pressure of carbon dioxide in mixed venous blood.
Measured: Baseline
Mixed venous CO2 pressure (PVCO2)
Partial pressure of carbon dioxide in mixed venous blood.
Measured: Day 3
PH
Measure of the venous blood acidity or alkalinity
Measured: Baseline
PH
Measure of the venous blood acidity or alkalinity
Measured: Day 3
HCO3
The amount of bicarbonate ion in the venous blood
Measured: Baseline
HCO3
The amount of bicarbonate ion in the venous blood
Measured: Day 3
Oxygen saturation (O2 Sat) from VBG
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
Measured: Baseline
Oxygen saturation (O2 Sat) from VBG
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
Measured: Day 3
Three minute walk test
The distance a patient can walk during three minute
Measured: Baseline
Three minute walk test
The distance a patient can walk during three minute
Measured: Day 3
O2 Sat after one minute walking
Measured: Baseline
O2 Sat after one minute walking
Measured: Day 3
O2 Sat after two minutes use of Partial Rebreather
Measured: Baseline
O2 Sat after two minutes use of Partial Rebreather
Measured: Day 3
O2 Sat after two minutes free air breathing
Measured: Baseline
O2 Sat after two minutes free air breathing
Measured: Day 3
O2 sat/ Fio2
Measured: Baseline
O2 sat/ Fio2
Measured: Day 3
Secondary outcomes (5)
Mortality rate
The number of dead subjects compared to total patients
Measured: until one month
Number of participants with Rehospitalization
Patients' hospitalization after discharge due to any reason
Measured: until one moth
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.
Measured: One month after end of intervention
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.
Measured: Baseline
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.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start2 Apr 2020
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All the enrolled participants will be allocated to the intervention of control groups using blocked-balanced randomization method.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Javaherian, Tehran University of Medical Sciences
- Investigators
- Mohammad Javaherian, Ph.D. cand., Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357340
- Sponsor's protocol ID
- 99-1-103-47429
- Status last verified
- May 2020
- First submitted
- 13 Apr 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in this article, after de-identification
Publications
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.
PubMed 31978945Read JM, Bridgen JRE, Cummings DAT, Ho A, Jewell CP. Novel coronavirus 2019-nCoV (COVID-19): early estimation of epidemiological parameters and epidemic size estimates. Philos Trans R Soc Lond B Biol Sci. 2021 Jul 19;376(1829):20200265. doi: 10.1098/rstb.2020.0265. Epub 2021 May 31.
PubMed 34053269Huang 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.
PubMed 31986264Chen 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.
PubMed 32032682Liu T, Hu J, Kang M, Lin L, Zhong H, Xiao J, et al. Transmission dynamics of 2019 novel coronavirus (2019-nCoV). 2020.
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.
PubMed 31995857Bott 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. No abstract available.
PubMed 19406863Strickland 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.
PubMed 26113566Yang 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.
PubMed 32164083Jin 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.
PubMed 32213556Novoa N, Ballesteros E, Jimenez 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.
PubMed 21227711Ambrosino N, Makhabah DN. Comprehensive physiotherapy management in ARDS. Minerva Anestesiol. 2013 May;79(5):554-63. Epub 2013 Jan 10.
PubMed 23306398Munshi 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.
PubMed 27898220Paulus 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.
PubMed 22863373Hillegass E. Essentials of Cardiopulmonary Physical Therapy-E-Book: Elsevier Health Sciences; 2016.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulmonary Physiotherapy on Hospitalized Patients With Novel Coronavirus 2019 Pneumonia
- ClinicalTrials.gov ID
- NCT04357340
- Acronym / sponsor ID
- 99-1-103-47429
- Conditions
- Covid-19, Pneumonia, SARS Pneumonia
- Keywords
- Pulmonary Physiotherapy, 2019 novel coronavirus disease, COVID-19, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All the enrolled participants will be allocated to the intervention of control groups using blocked-balanced randomization method.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Physiotherapy Techniques group | Experimental | Other: Pulmonary Physiotherapy TechniquesPulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer. |
| Control group | No intervention | –Incentive spirometer only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Physiotherapy TechniquesParticipants 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). | Other | Pulmonary Physiotherapy Techniques group |
Primary outcome
Mixed venous O2 pressure (PVO2)
Time frame: Baseline
Partial pressure of oxygen in mixed venous blood.
Mixed venous O2 pressure (PVO2)
Time frame: Day 3
Partial pressure of oxygen in mixed venous blood.
Mixed venous CO2 pressure (PVCO2)
Time frame: Baseline
Partial pressure of carbon dioxide in mixed venous blood.
Mixed venous CO2 pressure (PVCO2)
Time frame: Day 3
Partial pressure of carbon dioxide in mixed venous blood.
PH
Time frame: Baseline
Measure of the venous blood acidity or alkalinity
PH
Time frame: Day 3
Measure of the venous blood acidity or alkalinity
HCO3
Time frame: Baseline
The amount of bicarbonate ion in the venous blood
HCO3
Time frame: Day 3
The amount of bicarbonate ion in the venous blood
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
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
Three minute walk test
Time frame: Baseline
The distance a patient can walk during three minute
Three minute walk test
Time frame: Day 3
The distance a patient can walk during three minute
O2 Sat after one minute walking
Time frame: Baseline
O2 Sat after one minute walking
Time frame: Day 3
O2 Sat after two minutes use of Partial Rebreather
Time frame: Baseline
O2 Sat after two minutes use of Partial Rebreather
Time frame: Day 3
O2 Sat after two minutes free air breathing
Time frame: Baseline
O2 Sat after two minutes free air breathing
Time frame: Day 3
O2 sat/ Fio2
Time frame: Baseline
O2 sat/ Fio2
Time frame: Day 3
5 secondary outcomes
Mortality rate
Time frame: until one month
Number of participants with Rehospitalization
Time frame: until one moth
The Health-Related Quality of Life (HRQOL)
Time frame: One month after end of intervention
breathlessness
Time frame: Baseline
breathlessness
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Background: PubMed 31978945Zhu 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.
- Background: PubMed 34053269Read JM, Bridgen JRE, Cummings DAT, Ho A, Jewell CP. Novel coronavirus 2019-nCoV (COVID-19): early estimation of epidemiological parameters and epidemic size estimates. Philos Trans R Soc Lond B Biol Sci. 2021 Jul 19;376(1829):20200265. doi: 10.1098/rstb.2020.0265. Epub 2021 May 31.
- Background: PubMed 31986264Huang 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.
- Background: PubMed 32032682Chen 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.
- BackgroundLiu T, Hu J, Kang M, Lin L, Zhong H, Xiao J, et al. Transmission dynamics of 2019 novel coronavirus (2019-nCoV). 2020.
- Background: PubMed 31995857Li 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.
- Background: PubMed 19406863Bott 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. No abstract available.
- Background: PubMed 26113566Strickland 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.
- Background: PubMed 32164083Yang 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.
- Background: PubMed 32213556Jin 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.
- Background: PubMed 21227711Novoa N, Ballesteros E, Jimenez 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.
- Background: PubMed 23306398Ambrosino N, Makhabah DN. Comprehensive physiotherapy management in ARDS. Minerva Anestesiol. 2013 May;79(5):554-63. Epub 2013 Jan 10.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in this article, after de-identification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Javaherian, Ph.D. cand. principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Physiotherapy Techniques in people with Covid-19 and Pneumonia, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mixed venous O2 pressure (PVO2) (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357340, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.