Study Results
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Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2021-06-12
2022-04-30
Brief Summary
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Tele-medicine is a tool to connect patients and health care professions while maintaining social distancing and restrictions. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing therapy.
Since some months ago, different organizations have started the tele-physiotherapy/tele-rehabilitation program to manage the patients' complications after COVID-19. This research team have developed a tele-rehabilitation guideline for physiotherapists to help them how to use tele-physiotherapy program for patients after COVID-19 hospitalization. The aim of this study is to evaluate the efficacy of tele-physiotherapy program in patients discharged after COVID-19.
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Detailed Description
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Due to multisystem nature of this disease, it can cause a variety of early and late complications. New studies have revealed some of the long-term sequelae of this disease, such as neurological injuries, arterial or venous thrombosis, cardiac, brain strokes, etc. which need to be taken into consideration during management of patients. Many COVID-19 survivors who require critical care may also develop psychological, physical and cognitive impairments. These patients may develop various impairments because of hospitalization owing to extended immobilization and many hours bed ridden; these include neuromuscular complications, severe muscle weakness and fatigue, joint stiffness, dysphagia, psychological problems, reduced mobility, low quality of life, frequent falls, and even quadriparesis.
Given impacts of COVID-19 on global health care system, innovative approaches in managing patients are needed. This is the reason that tele-medicine is becoming a trendy title for researchers . Tele-medicine is a tool to connect patients and health care professions while maintaining social distancing and restrictions . Digital health interventions can help provide self-monitoring tools, field updates, exercise protocols, and psychological support. Depending on the funding and facilities provided by the health care system, tele-medicine can be designed and employed in each country uniquely.
Physiotherapy interventions can be also delivered through modern digital communication tools. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing therapy wherever is most convenient for the patient through the use of modern digital communication.
Based on the evidences from other outbreak of viruses in the coronavirus strain epidemics, many of the discharged patients after COVID-19 pneumonia are likely to have residual impairment even some years after hospitalization. Not only discharged COVID-19 patients, but also other members of the society might need physiotherapy in this crisis. Despite this need, social distancing should be taken into account and human lives can't be put in danger. Tele-physiotherapy provides a great opportunity for therapists to communicate with their patients, assess and treat them.
Since some months ago, different organizations have started the tele-physiotherapy/tele-rehabilitation program to manage the patients' complications after COVID-19. This research team have developed a tele-rehabilitation guideline for physiotherapists to help them how to use tele-physiotherapy program for patients after COVID-19 hospitalization. The aim of this study is to evaluate the efficacy of tele-physiotherapy program in patients discharged after COVID-19.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The sample size was calculated to identify clinically relevant effects on the primary outcome, the distance of six-minute walk test. The calculation was performed using STATA 16 software. Presuming a two-sided significance level (α) of 0.05, the power of 80% (β=0.20) and standard deviation based on the results of a relevant study in COVID-19 survivors which assessed the distance of six-minute walk test. Minimal clinically important difference (MCID) of 54m was reported and considered to be clinically significant. Repeated measurement of ANCOVA was used for the calculation with a baseline and two follow-up measurements (correlation of repeated measurement=0.499). After considering 20% possible participants attrition, It was determined that a sample size of 72 participants would be required to detect a significant change, 36 in each group.
TREATMENT
SINGLE
Study Groups
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Tele-physiotherapy group
Allocated participants to this group will receive 18 physiotherapy sessions (three sessions per week) during six weeks. in these sessions, physiotherapist will prescribe aerobic, resistive, breathing and functional exercises and airway clearance techniques (if needed) based on result of assessment of patients at the discharge phase. the physiotherapist will use some educational contents for the patient and call him/her to guide the patient about how exercises should be performed (determining frequency, time, intensity and type of exercise). the patient should do exercises until next session and provide a feedback. The patient will be assessed weekly using a pre-designed questionnaire remotely. the progression of interventions will be based on the results of weekly assessment.
Tele-physiotherapy group
Allocated participants to this group will receive 18 physiotherapy sessions (three sessions per week) during six weeks. in these sessions, physiotherapist will prescribe aerobic, resistive, breathing and functional exercises and airway clearance techniques (if needed) based on result of assessment of patients at the discharge phase. the physiotherapist will use some educational contents for the patient and call him/her to guide the patient about how exercises should be performed (determining frequency, time, intensity and type of exercise). the patient should do exercises until next session and provide a feedback. The patient will be assessed weekly using a pre-designed questionnaire remotely. the progression of interventions will be based on the results of weekly assessment.
Control group
Allocated participants to control group will receive one consultation session by the physiotherapist. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking, using oxygen cylinder and dietary.
Control group
Allocated participants to control group will receive one consultation session by the physiotherapist. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking, using oxygen cylinder and dietary.
Interventions
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Tele-physiotherapy group
Allocated participants to this group will receive 18 physiotherapy sessions (three sessions per week) during six weeks. in these sessions, physiotherapist will prescribe aerobic, resistive, breathing and functional exercises and airway clearance techniques (if needed) based on result of assessment of patients at the discharge phase. the physiotherapist will use some educational contents for the patient and call him/her to guide the patient about how exercises should be performed (determining frequency, time, intensity and type of exercise). the patient should do exercises until next session and provide a feedback. The patient will be assessed weekly using a pre-designed questionnaire remotely. the progression of interventions will be based on the results of weekly assessment.
Control group
Allocated participants to control group will receive one consultation session by the physiotherapist. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking, using oxygen cylinder and dietary.
Eligibility Criteria
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Inclusion Criteria
* Having at least one rT-PCR Covid test,
* Duration of hospitalization \> 10 days,
* Ability to walk,
* Totally oriented,
* Ability to use smartphone,
* Ability to read and write in Persian.
Exclusion Criteria
* Severe cardiovascular impairments.
18 Years
75 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Mohammad Javaherian
Principal Investigator, Liver Transplantation Research Center
Principal Investigators
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Mohammad Javaherian, Ph.D. cand.
Role: PRINCIPAL_INVESTIGATOR
Tehran University of Medical Sciences
Mohsen Nasiri-toosi, MD.
Role: STUDY_DIRECTOR
Tehran University of Medical Sciences
Behrouz Attarbashi Moghadam, Ph.D.
Role: STUDY_DIRECTOR
Tehran University of Medical Sciences
Locations
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Imam Khomeini Hospital Complex
Tehran, , Iran
Countries
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References
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Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
Vasheghani-Farahani A, Tahmasbi M, Asheri H, Ashraf H, Nedjat S, Kordi R. The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study. Asian J Sports Med. 2011 Jun;2(2):106-16. doi: 10.5812/asjsm.34781.
Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
Azimian M, Farahani AS, Dadkhah A, Fallahpour M, Karimlu M. Fatigue severity scale: the psychometric properties of the persian-version in patients with multiple sclerosis. Res J Biol Sci. 2009;4(9):974-7.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): translation and validation study of the Iranian version. Qual Life Res. 2005 Apr;14(3):875-82. doi: 10.1007/s11136-004-1014-5.
Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.
World Health Organization. COVID-19 clinical management: living guidance, 25 January 2021. World Health Organization; 2021.
SeyedAlinaghi S, Afsahi AM, MohsseniPour M, Behnezhad F, Salehi MA, Barzegary A, Mirzapour P, Mehraeen E, Dadras O. Late Complications of COVID-19; a Systematic Review of Current Evidence. Arch Acad Emerg Med. 2021 Jan 20;9(1):e14. doi: 10.22037/aaem.v9i1.1058. eCollection 2021. No abstract available.
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.
Portnoy J, Waller M, Elliott T. Telemedicine in the Era of COVID-19. J Allergy Clin Immunol Pract. 2020 May;8(5):1489-1491. doi: 10.1016/j.jaip.2020.03.008. Epub 2020 Mar 24. No abstract available.
Salawu A, Green A, Crooks MG, Brixey N, Ross DH, Sivan M. A Proposal for Multidisciplinary Tele-Rehabilitation in the Assessment and Rehabilitation of COVID-19 Survivors. Int J Environ Res Public Health. 2020 Jul 7;17(13):4890. doi: 10.3390/ijerph17134890.
Cortes-Telles A, Lopez-Romero S, Figueroa-Hurtado E, Pou-Aguilar YN, Wong AW, Milne KM, Ryerson CJ, Guenette JA. Pulmonary function and functional capacity in COVID-19 survivors with persistent dyspnoea. Respir Physiol Neurobiol. 2021 Jun;288:103644. doi: 10.1016/j.resp.2021.103644. Epub 2021 Feb 27.
Jenkins SC. 6-Minute walk test in patients with COPD: clinical applications in pulmonary rehabilitation. Physiotherapy. 2007 Sep 1;93(3):175-82.
Javaherian M, Shadmehr A, Keshtkar A, Beigmohammadi MT, Dabbaghipour N, Syed A, Attarbashi Moghadam B. Safety and efficacy of pulmonary physiotherapy in hospitalized patients with severe COVID-19 pneumonia (PPTCOVID study): A prospective, randomised, single-blind, controlled trial. PLoS One. 2023 Jan 31;18(1):e0268428. doi: 10.1371/journal.pone.0268428. eCollection 2023.
Other Identifiers
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99-2-246-49892
Identifier Type: -
Identifier Source: org_study_id
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