Covid19NCT04895371
Tele-Physiotherapy After COVID-19 Hospitalization
A study testing Tele-physiotherapy group in people with Covid19 and Coronavirus Disease 2019, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic. Tele-medicine is a tool to connect patients and health care professions while maintaining social distancing and restrictions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, Coronavirus Disease 2019
- What is being tested?
- Tele-physiotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIran
- Study dates
- 12 Jun 2021to 30 Apr 2022
- 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
- Discharged patients with Covid-19 pneumonia,
- 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.
Who cannot join
- Having any kind of musculoskeletal disorder causing inability to participate in physiotherapy sessions,
- Severe cardiovascular impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Tele-Physiotherapy in Patients After COVID-19 Hospitalization: The PPTCOVID Study
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic.
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.
Read the detailed description
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic.
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
- Covid19, Coronavirus Disease 2019
- Being tested
- Tele-physiotherapy group, Control group
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-physiotherapy groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-physiotherapy group | Experimental | 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. Receives: Other: Tele-physiotherapy group |
| Control group | Active comparator | 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test (6MWT)
6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.
Measured: Baseline
6-Minute Walk Test (6MWT)
6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.
Measured: After six weeks
6-Minute Walk Test (6MWT)
6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.
Measured: After 10 weeks
Secondary outcomes (27)
Five Times Sit to Stand test (5TST)
The five times sit to stand is a test which measures the time for sitting and standing from a chair for five times. it is commonly used to assess strength of lower extremity, transitional movements and falling risks in adults.
Measured: Baseline
Five Times Sit to Stand test (5TST)
The five times sit to stand is a test which measures the time for sitting and standing from a chair for five times. it is commonly used to assess strength of lower extremity, transitional movements and falling risks in adults.
Measured: After six weeks
Five Times Sit to Stand test (5TST)
The five times sit to stand is a test which measures the time for sitting and standing from a chair for five times. it is commonly used to assess strength of lower extremity, transitional movements and falling risks in adults.
Measured: After 10 weeks
Fatigue Severity Scale (FSS)
Fatigue Severity Scale is a short nine statement questionnaire which is used to assess the impact of fatigue on individuals. the questionnaire asks the individuals to rate the level of their fatigue. FSS scores vary from 9 to 63 and higher scores present higher fatigue (worsened).
Measured: Baseline
Fatigue Severity Scale (FSS)
Fatigue Severity Scale is a short nine statement questionnaire which is used to assess the impact of fatigue on individuals. the questionnaire asks the individuals to rate the level of their fatigue. FSS scores vary from 9 to 63 and higher scores present higher fatigue (worsened).
Measured: After six weeks
Fatigue Severity Scale (FSS)
Fatigue Severity Scale is a short nine statement questionnaire which is used to assess the impact of fatigue on individuals. the questionnaire asks the individuals to rate the level of their fatigue. FSS scores vary from 9 to 63 and higher scores present higher fatigue (worsened).
Measured: After 10 weeks
International Physical Activity Questionnaire (IPAQ)
The IPAQ is a 27-item subjective measure of physical activity. This instrument is repetitively used instrument to assess the physical activity. This instrument was developed to assess physical activity in adults aged 18-65 years. The Persian version of IPAQ was translated and cross-cultural adapted by Moghaddam et al. (2012).
Measured: Baseline
International Physical Activity Questionnaire (IPAQ)
The IPAQ is a 27-item subjective measure of physical activity. This instrument is repetitively used instrument to assess the physical activity. This instrument was developed to assess physical activity in adults aged 18-65 years. The Persian version of IPAQ was translated and cross-cultural adapted by Moghaddam et al. (2012).
Measured: After six weeks
International Physical Activity Questionnaire (IPAQ)
The IPAQ is a 27-item subjective measure of physical activity. This instrument is repetitively used instrument to assess the physical activity. This instrument was developed to assess physical activity in adults aged 18-65 years. The Persian version of IPAQ was translated and cross-cultural adapted by Moghaddam et al. (2012).
Measured: After 10 weeks
Level of dyspnea
Level of dyspnea is assessed by modified Borg scale. the patient will report his or her level of dyspnea after 6-minute walk test in range of 0(without dyspnea) to 10(most severe dyspnea).
Measured: Baseline
Level of dyspnea
Level of dyspnea is assessed by modified Borg scale. the patient will report his or her level of dyspnea after 6-minute walk test in range of 0(without dyspnea) to 10(most severe dyspnea).
Measured: After six weeks
Level of dyspnea
Level of dyspnea is assessed by modified Borg scale. the patient will report his or her level of dyspnea after 6-minute walk test in range of 0(without dyspnea) to 10(most severe dyspnea).
Measured: After 10 weeks
Short From-36
Short Form-36 is a self report instrument which evaluate eight domains of health. it is commonly used as a person or population's quality of life.
Measured: Baseline
Short From-36
Short Form-36 is a self report instrument which evaluate eight domains of health. it is commonly used as a person or population's quality of life.
Measured: After six weeks
Short From-36
Short Form-36 is a self report instrument which evaluate eight domains of health. it is commonly used as a person or population's quality of life.
Measured: After 10 weeks
Strength of shoulder abduction muscle group
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: Baseline
Strength of shoulder abduction muscle group
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: After six weeks
Strength of shoulder abduction muscle group
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: After 10 weeks
Strength of hip abduction muscle group
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: Baseline
Strength of hip abduction muscle group
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: After six weeks
Strength of hip abduction muscle group
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: After 10 weeks
Strength of knee extension muscle group
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: Baseline
Strength of knee extension muscle group
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: After six weeks
Strength of knee extension muscle group
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: After 10 weeks
Strength of elbow flexion muscle group
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: Baseline
Strength of elbow flexion muscle group
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: After six weeks
Strength of elbow flexion muscle group
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Measured: After 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start12 Jun 2021
- Primary completion20 Nov 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- The participants will be randomly allocated to Tele-physiotherapy or control groups. 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 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 SciencesMohsen Nasiri-toosi, MD., Study director, Tehran University of Medical SciencesBehrouz Attarbashi Moghadam, Ph.D., Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895371
- Sponsor's protocol ID
- 99-2-246-49892
- Status last verified
- May 2022
- First submitted
- 15 May 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All related mentioned data will be available through the principle investigator (Email: Javaherian\_m@razi.tums.ac.ir) for researchers who provide a related approved proposal and ethical committee approve to achieve aims. These data will be available with publication date until one year.
Publications
Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
PubMed 12890299Craig 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.
PubMed 12900694Vasheghani-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.
PubMed 22375226Bohannon 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.
PubMed 7624188Krupp 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.
PubMed 2803071Azimian 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.
PubMed 1593914Montazeri 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.
PubMed 16022079Thomas 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.
PubMed 32312646World 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.
PubMed 33681819Zhu 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 31978945Portnoy 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.
PubMed 32220575Salawu 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.
PubMed 32645876Cortes-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.
PubMed 33647535
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Tele-Physiotherapy in Patients After COVID-19 Hospitalization: The PPTCOVID Study
- ClinicalTrials.gov ID
- NCT04895371
- Acronym / sponsor ID
- 99-2-246-49892
- Conditions
- Covid19, Coronavirus Disease 2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 20 May 2021 (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.
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic.
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.
Detailed description
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomly allocated to Tele-physiotherapy or control groups. 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.
| Arm | Type | Receives |
|---|---|---|
| Tele-physiotherapy group | Experimental | Other: Tele-physiotherapy groupAllocated 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 | Active comparator | Other: Control groupAllocated 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Discharged patients with Covid-19 pneumonia,
- Having at least one rT-PCR Covid test,
- Duration of hospitalization > 10 days,
- Ability to walk,
- Totally oriented,
Key exclusion criteria (2 listed)
- Having any kind of musculoskeletal disorder causing inability to participate in physiotherapy sessions,
- Severe cardiovascular impairments.
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 |
|---|---|---|
| Tele-physiotherapy groupAllocated 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. | Other | Tele-physiotherapy group |
| Control groupAllocated 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. | Other | Control group |
Primary outcome
6-Minute Walk Test (6MWT)
Time frame: Baseline
6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.
6-Minute Walk Test (6MWT)
Time frame: After six weeks
6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.
6-Minute Walk Test (6MWT)
Time frame: After 10 weeks
6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.
27 secondary outcomes
Five Times Sit to Stand test (5TST)
Time frame: Baseline
Five Times Sit to Stand test (5TST)
Time frame: After six weeks
Five Times Sit to Stand test (5TST)
Time frame: After 10 weeks
Fatigue Severity Scale (FSS)
Time frame: Baseline
Fatigue Severity Scale (FSS)
Time frame: After six weeks
Fatigue Severity Scale (FSS)
Time frame: After 10 weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline
International Physical Activity Questionnaire (IPAQ)
Time frame: After six weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: After 10 weeks
Level of dyspnea
Time frame: Baseline
Level of dyspnea
Time frame: After six weeks
Level of dyspnea
Time frame: After 10 weeks
Short From-36
Time frame: Baseline
Short From-36
Time frame: After six weeks
Short From-36
Time frame: After 10 weeks
Strength of shoulder abduction muscle group
Time frame: Baseline
Strength of shoulder abduction muscle group
Time frame: After six weeks
Strength of shoulder abduction muscle group
Time frame: After 10 weeks
Strength of hip abduction muscle group
Time frame: Baseline
Strength of hip abduction muscle group
Time frame: After six weeks
Strength of hip abduction muscle group
Time frame: After 10 weeks
Strength of knee extension muscle group
Time frame: Baseline
Strength of knee extension muscle group
Time frame: After six weeks
Strength of knee extension muscle group
Time frame: After 10 weeks
Strength of elbow flexion muscle group
Time frame: Baseline
Strength of elbow flexion muscle group
Time frame: After six weeks
Strength of elbow flexion muscle group
Time frame: After 10 weeks
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 3 Jun 2022.
- Background: PubMed 12890299Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
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- Individual participant dataSharing planned: Yes. All related mentioned data will be available through the principle investigator (Email: Javaherian_m@razi.tums.ac.ir) for researchers who provide a related approved proposal and ethical committee approve to achieve aims. These data will be available with publication date until one year.
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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
Mohsen Nasiri-toosi, MD. study director
Tehran University of Medical Sciences
Behrouz Attarbashi Moghadam, Ph.D. study director
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 Tele-physiotherapy group in people with Covid19 and Coronavirus Disease 2019, 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 7 inclusion and 2 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 3 Jun 2022. 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?
6-Minute Walk Test (6MWT) (time frame: Baseline). The study lists 3 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 NCT04895371, which also lists 17 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 3 Jun 2022.