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This study aims to evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional physical therapy treatment and IMT | Experimental | The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status. In addition, the patient will receive inspiratory muscle training (IMT) by using a threshold IMT device. Patient will ask to use the device twice daily. In each time, patient will perform 3 sets of 10 breaths with 1-minute rest between sets. Exercise intensity will start with 10 % of pre-measured maximal inspiratory pressure. Once the patient successfully completed 30 breath twice a day, the exercise load will increase 5% more in the subsequent training session. This treatment protocol will perform daily for 2 weeks. |
|
| Conventional physical therapy | Active Comparator | The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Threshold IMT device | Device | 10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Respiratory muscle performance | Changes in Respiratory muscle performance will be determined by using the Respiratory Pressure Meter device. Patient will perform full inspiration through this device for 1.5 seconds via the mouth (nose occluded). The reading of the negative peak pressure that is maintained for 1 second in the device is a maximal inspiration peak. | Baseline, 1st week, 2nd week, one month |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Blood pressure measured by electronic BP machine before and after session | Daily from baseline to hospital discharge (2 weeks) |
| Heart rate | measured by heart rate monitor before and after session |
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Inclusion Criteria:
Non- intubated patient diagnosed with moderate to severe pneumonia (confirmed by chest x-ray and officially reported) as secondary to COVID-19 with one more symptom such as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jassim M Alghaith, PhD. | Contact | (965)99558185 | Alghaith328@gmail.com | |
| Abdulaziz Al-Husaini, MSc. | Contact | health_aura@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaber Al-Ahmed Hospital | Kuwait City | Kuwait |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | WHO, CORONAVIRUS DISEASE (COVID-19) OUTBREAK: RIGHTS, ROLES AND RESPONSIBILITIES OF HEALTH WORKERS, INCLUDING KEY CONSIDERATIONS FOR OCCUPATIONAL SAFETY AND HEALTH 2020. | ||
| 32109013 | Background | Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. | |
| 32150360 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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A pilot study following a randomized controlled trial design.
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COVID-19 patient will be blinded from the study aim. The outcomes assessor will be blinded from the study aim and patient allocation.
| Conventional physical therapy | Other | daily |
|
| Daily from baseline to hospital discharge (2 weeks) |
| Oxygen saturation | Measured by pulse oximeter before and after session | Daily from baseline to hospital discharge (2 weeks) |
| Oxygen supplementation | Number of % of oxygen patient on it before and after session | Daily from baseline to hospital discharge (2 weeks). |
| Oxygen flow rate | measuring the number of time where the oxygen above or below 4L/min. | Daily from baseline to hospital discharge (2 weeks) |
| Dyspnoea level | By using Borg scale (rating of perceived exertion scale), Possible score range from 0 (nothing) to 10 ( Maximal exertion). Before and after session. | Daily from baseline to hospital discharge (2 weeks) |
| Pain level | By using visual analogue scale. Possible score range from 0 (no pain) to 10 (worst possible pain) Before and after session. | Daily from baseline to hospital discharge (2 weeks) |
| Respiratory rate | Measured by Respiratory rate monitor. Before and after session | Daily from baseline to hospital discharge (2 weeks) |
| Threshold IMT device | Recording number for breath and sets daily. | Daily from baseline to 1 month from admission |
| Background |
| Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/ |
| 32091533 | Background | Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. |
| 32191259 | Background | Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326. |
| 32181795 | Background | Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available. |
| 32171076 | Background | Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. |
| 31134099 | Background | Honce R, Schultz-Cherry S. Impact of Obesity on Influenza A Virus Pathogenesis, Immune Response, and Evolution. Front Immunol. 2019 May 10;10:1071. doi: 10.3389/fimmu.2019.01071. eCollection 2019. |
| 32227758 | Background | Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30. |
| 32409502 | Background | Cai Q, Chen F, Wang T, Luo F, Liu X, Wu Q, He Q, Wang Z, Liu Y, Liu L, Chen J, Xu L. Obesity and COVID-19 Severity in a Designated Hospital in Shenzhen, China. Diabetes Care. 2020 Jul;43(7):1392-1398. doi: 10.2337/dc20-0576. Epub 2020 May 14. |
| 32766546 | Background | Almazeedi S, Al-Youha S, Jamal MH, Al-Haddad M, Al-Muhaini A, Al-Ghimlas F, Al-Sabah S. Characteristics, risk factors and outcomes among the first consecutive 1096 patients diagnosed with COVID-19 in Kuwait. EClinicalMedicine. 2020 Jul 4;24:100448. doi: 10.1016/j.eclinm.2020.100448. eCollection 2020 Jul. |
| 12186831 | Background | American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available. |
| 30956204 | Background | Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun. |
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| 23295957 | Background | Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583. |
| 21310113 | Background | Dimitriadis Z, Kapreli E, Konstantinidou I, Oldham J, Strimpakos N. Test/retest reliability of maximum mouth pressure measurements with the MicroRPM in healthy volunteers. Respir Care. 2011 Jun;56(6):776-82. doi: 10.4187/respcare.00783. Epub 2011 Feb 9. |
| 31074198 | Background | Ferraro FV, Gavin JP, Wainwright T, McConnell A. The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study. Physiol Rep. 2019 May;7(9):e14076. doi: 10.14814/phy2.14076. |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |