Tele-Physiotherapy After COVID-19 Hospitalization

May 31, 2022 updated by: Mohammad Javaherian, Tehran University of Medical Sciences

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
After six weeks
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.
After 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five Times Sit to Stand test (5TST)
Time Frame: Baseline
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)
Time Frame: After six weeks
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)
Time Frame: After 10 weeks
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)
Time Frame: Baseline
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)
Time Frame: After six weeks
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)
Time Frame: After 10 weeks
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)
Time Frame: Baseline
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)
Time Frame: After six weeks
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)
Time Frame: After 10 weeks
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
Time Frame: Baseline
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
Time Frame: After six weeks
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
Time Frame: After 10 weeks
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
Time Frame: Baseline
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
Time Frame: After six weeks
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
Time Frame: After 10 weeks
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
Time Frame: Baseline
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
Time Frame: After six weeks
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
Time Frame: After 10 weeks
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
Time Frame: Baseline
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
Time Frame: After six weeks
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
Time Frame: After 10 weeks
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
Time Frame: Baseline
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
Time Frame: After six weeks
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
Time Frame: After 10 weeks
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
Time Frame: Baseline
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
Time Frame: After six weeks
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
Time Frame: After 10 weeks
Strength of elbow flexion muscle group is assessed by hand held dynamometer and will be presented in kilogram.
After 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mohsen Nasiri-toosi, MD., Tehran University of Medical Sciences
  • Study Director: Behrouz Attarbashi Moghadam, Ph.D., Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2021

Primary Completion (Actual)

November 20, 2021

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

May 15, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Tele-physiotherapy group

3
Subscribe