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Tele-Physiotherapy After COVID-19 Hospitalization

Primary Purpose

Covid19, Coronavirus Disease 2019

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Tele-physiotherapy group
Control group
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imam Khomeini Hospital Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-physiotherapy group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
Strength of shoulder abduction muscle group
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of shoulder abduction muscle group
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of shoulder abduction muscle group
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of hip abduction muscle group
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of hip abduction muscle group
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of hip abduction muscle group
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of knee extension muscle group
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of knee extension muscle group
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of knee extension muscle group
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of elbow flexion muscle group
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of elbow flexion muscle group
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Strength of elbow flexion muscle group
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.

Full Information

First Posted
May 15, 2021
Last Updated
May 31, 2022
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04895371
Brief Title
Tele-Physiotherapy After COVID-19 Hospitalization
Official Title
The Efficacy of Tele-Physiotherapy in Patients After COVID-19 Hospitalization: The PPTCOVID Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2021 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Coronavirus Disease 2019

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 (ฮฑ) of 0.05, the power of 80% (ฮฒ=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
Outcomes Assessor
Masking Description
The assessor will be blinded to the randomization and allocation. The assessor will have not access to patients' medical record. Patients will be also asked to do not explain about their procedure to the assessor.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-physiotherapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tele-physiotherapy group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-Minute Walk Test (6MWT)
Description
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.
Time Frame
Baseline
Title
6-Minute Walk Test (6MWT)
Description
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.
Time Frame
After six weeks
Title
6-Minute Walk Test (6MWT)
Description
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.
Time Frame
After 10 weeks
Secondary Outcome Measure Information:
Title
Five Times Sit to Stand test (5TST)
Description
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.
Time Frame
Baseline
Title
Five Times Sit to Stand test (5TST)
Description
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.
Time Frame
After six weeks
Title
Five Times Sit to Stand test (5TST)
Description
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.
Time Frame
After 10 weeks
Title
Fatigue Severity Scale (FSS)
Description
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).
Time Frame
Baseline
Title
Fatigue Severity Scale (FSS)
Description
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).
Time Frame
After six weeks
Title
Fatigue Severity Scale (FSS)
Description
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).
Time Frame
After 10 weeks
Title
International Physical Activity Questionnaire (IPAQ)
Description
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).
Time Frame
Baseline
Title
International Physical Activity Questionnaire (IPAQ)
Description
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).
Time Frame
After six weeks
Title
International Physical Activity Questionnaire (IPAQ)
Description
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).
Time Frame
After 10 weeks
Title
Level of dyspnea
Description
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).
Time Frame
Baseline
Title
Level of dyspnea
Description
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).
Time Frame
After six weeks
Title
Level of dyspnea
Description
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).
Time Frame
After 10 weeks
Title
Short From-36
Description
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.
Time Frame
Baseline
Title
Short From-36
Description
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.
Time Frame
After six weeks
Title
Short From-36
Description
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.
Time Frame
After 10 weeks
Title
Strength of shoulder abduction muscle group
Description
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
Baseline
Title
Strength of shoulder abduction muscle group
Description
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
After six weeks
Title
Strength of shoulder abduction muscle group
Description
Strength of shoulder abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
After 10 weeks
Title
Strength of hip abduction muscle group
Description
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
Baseline
Title
Strength of hip abduction muscle group
Description
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
After six weeks
Title
Strength of hip abduction muscle group
Description
Strength of hip abduction muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
After 10 weeks
Title
Strength of knee extension muscle group
Description
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
Baseline
Title
Strength of knee extension muscle group
Description
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
After six weeks
Title
Strength of knee extension muscle group
Description
Strength of knee extension muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
After 10 weeks
Title
Strength of elbow flexion muscle group
Description
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
Baseline
Title
Strength of elbow flexion muscle group
Description
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
After six weeks
Title
Strength of elbow flexion muscle group
Description
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
Time Frame
After 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Javaherian, Ph.D. cand.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohsen Nasiri-toosi, MD.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Behrouz Attarbashi Moghadam, Ph.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Imam Khomeini Hospital Complex
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Until one year after result publication.
IPD Sharing Access Criteria
All researchers who provide a related approved proposal and ethical committee approve to achieve aims.
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Tele-Physiotherapy After COVID-19 Hospitalization

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