Tele-Physiotherapy After COVID-19 Hospitalization

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of Tele-Physiotherapy in Patients After COVID-19 Hospitalization: The PPTCOVID Study

Conditions
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Covid19, Coronavirus Disease 2019

Intervention / Treatment
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* Other: Tele-physiotherapy group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Having any kind of musculoskeletal disorder causing inability to participate in physiotherapy sessions, Severe cardiovascular impairments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-physiotherapy group<br>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. | Other: Tele-physiotherapy group<br>* 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.<br>|
| Active Comparator: Control group<br>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. | Other: Control group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | After 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | After 10 weeks |