Tele-Physiotherapy After COVID-19 Hospitalization

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895371
• Other study ID #: 99-2-246-49892
• Status: Completed
• Phase: N/A
• Start date: June 12, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 30, 2022
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• COVID-19
• Covid19

Intervention

Other:
• Tele-physiotherapy group
Allocated participants to this group will receive 18 physiotherapy sessions (three sessions per week) during six weeks. in these sessions, physiotherapist will prescribe aerobic, resistive, breathing and functional exercises and airway clearance techniques (if needed) based on result of assessment of patients at the discharge phase. the physiotherapist will use some educational contents for the patient and call him/her to guide the patient about how exercises should be performed (determining frequency, time, intensity and type of exercise). the patient should do exercises until next session and provide a feedback. The patient will be assessed weekly using a pre-designed questionnaire remotely. the progression of interventions will be based on the results of weekly assessment.
• Control group
Allocated participants to control group will receive one consultation session by the physiotherapist. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking, using oxygen cylinder and dietary.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital Complex	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (17)

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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