Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges

March 8, 2023 updated by: Abdurrahman Tanhan, Bitlis Eren University
Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty seven participants will be enrolled. Participants will be randomly divided into 3 groups.

For this purpose, patients will be recruited at the time of discharge from the hospital and two experimental groups with the same physical therapy and educational program will be carried out. participants in the control group will only educational program. Participants in experimental groups will be followed using videoconference interviews from synchronous telerehabilitation methods and mobile application from asynchronous telerehabilitation methods at home. These participants will be given an 8-week exercise program. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and the patients will be evaluated before and after the treatment.

After treatment programs, the functional capacity, performance, and hemodynamic parameters of the participants will be evaluated. Quality of life, physical activity level, anxiety-depression, and fatigue severity will also be evaluated with questionnaires.

Study Type

Interventional

Enrollment (Actual)

57

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

  • Turkey
    • İstanbul
      • Maltepe, İstanbul, Turkey, 34000
        • Marmara University

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:

  • COVID-19 patients in the subacute period discharged
  • Be 18 years or older
  • Having received oxygen therapy or mechanical ventilation support in the hospital
  • Access to online interviews and web-based exercises with a secure internet connection
  • Having sufficient speaking and hearing skills for telerehabilitation
  • Volunteer to participate in research

Exclusion Criteria:

  • Unstable clinical condition
  • Having had cerebrovascular disease, intra-articular drug injection or surgery of the lower extremities in the last 6 months
  • Inability to walk independently, even with an assistive device
  • Having serious neuromuscular problems
  • Not being cooperative enough to answer and understand questionnaires and scales

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synchronous telerehabilitation program (Video conference)
Participants will exercise program at home for an average of 30 minutes a day, 3 days a week, under the supervision of a physiotherapist via synchronized video conference. The program will continue for 8 weeks. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and an educational program. Physical exercises will be adjusted in 3 different difficulty levels: sitting, standing with or without support.
Other: Synchronous telerehabilitation programme
Exercise program and educational program
Other Names:
  • Video conference
Experimental: Asynchronous telerehabilitation programme (Mobil app.)
The same exercises as in the synchronous telerehabilitation program will be done at the same frequency. Participants will watch the videos sent by the investigator via the mobile application and then do the exercises at home. The participants will meet with the investigator once a week to an update exercise program.
Other: Asynchronous telerehabilitation programme
Exercise program educational program
Other Names:
  • Mobil application
No Intervention: Control
Participants in this group will only receive an educational program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental Shuttle Walk Test (ISWT)
Time Frame: Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months
The participant will be asked to walk around two 9-meter cones and complete them within the given time. Oxygen saturation and heart rate will be measured before and immediately after the test. They will be asked to self-report dyspnea and fatigue according to the modified Borg scale (0-10).
Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-Second Chair Stand Test (30 CST)
Time Frame: Change from baseline number of sitting and staying of the patients at the end of the 8th week and, postintervation sixth months
The patient will be asked to sit and stand as much as possible within 30 seconds, with his hands crossed over his chest. The number of sitting and staying for 30 seconds will be noted.
Change from baseline number of sitting and staying of the patients at the end of the 8th week and, postintervation sixth months
Brief Physical Performance Battery (BPPB)
Time Frame: Change from baseline score of the patients at the end of the 8th week and, postintervation sixth months
It is a test used to evaluate the lower extremity function of patients. This battery represents the sum of 3 functional tests such as standing stance tests, 4 meters walking test and 5 times chair sit and stand (5STS). Each test is scored between 0 (not completing the test) and 4 (highest performance level)
Change from baseline score of the patients at the end of the 8th week and, postintervation sixth months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Saturation and Heart Rate
Time Frame: Change from baseline oxygen saturation (SaO2) and heart rate (beats per minute) of the patients at the end of the 8th week and, postintervation sixth months
Participants' resting oxygen saturation and heart rate, and oxygen saturation and heart rate after the tests will be evaluated
Change from baseline oxygen saturation (SaO2) and heart rate (beats per minute) of the patients at the end of the 8th week and, postintervation sixth months
Dyspnea and Fatigue Level
Time Frame: Change from baseline dyspnea and fatigue of the patients at the end of the 8th week and, postintervation sixth months
Participants' dyspnea and fatigue level, and dyspnea and fatigue level after the tests will be evaluated according to the Modified Borg (0-10) scale
Change from baseline dyspnea and fatigue of the patients at the end of the 8th week and, postintervation sixth months
Timed Up-Go Test (TUG)
Time Frame: Change from baseline time (second) of the patients at the end of the 8th week and, postintervation sixth months
Participants are asked to get up from the chair, walk 3 m at a comfortable and safe pace, return and sit back in the chair.
Change from baseline time (second) of the patients at the end of the 8th week and, postintervation sixth months
International Physical Activity Questionnaire Short Form (IPAQ)
Time Frame: Change from baseline metabolic equivalent (MET)-minute/week of the patients at the end of the 8th week and, postintervation sixth months
It is a scale used to determine the level of physical activity in adults. The scale questions vigorous and moderate physical activity, walking time of at least 10 minutes and daily sitting time in the last 7 days.
Change from baseline metabolic equivalent (MET)-minute/week of the patients at the end of the 8th week and, postintervation sixth months
Hospital Anxiety Depression (HAD) Scale
Time Frame: Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
The questionnaire, which was filled in by the patient and includes the anxiety and depression subscales, consists of 14 items. Responses are scored between 0-3.
Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
Fatigue Severity Scale
Time Frame: Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
This scale is a 9-item scale that measures the severity of fatigue in patients and its effect on one's activities and lifestyle. Responses are scored on a seven-point scale with 1 = strongly disagree and 7 = strongly agree.
Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
Quality of Life Scale: Short Form-36 (SF-36)
Time Frame: Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
The self-assessment scale consists of 36 items and 8 sub-dimensions. The scale is evaluated considering the last four weeks. On the scale, 0 points indicate poor health and 100 points indicate good health.
Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months

Collaborators and Investigators

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

Sponsor

Bitlis Eren University

Collaborators

Marmara University

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)

September 25, 2021

Primary Completion (Actual)

August 5, 2022

Study Completion (Actual)

September 7, 2022

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BitlisErenU2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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