search
Back to results

Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges

Primary Purpose

COVID-19, Telerehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Synchronous telerehabilitation programme
Asynchronous telerehabilitation programme
Sponsored by
Bitlis Eren University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Telerehabilitation, Exercise program, Breathing exercises

Eligibility Criteria

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

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

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Synchronous telerehabilitation program (Video conference)

Asynchronous telerehabilitation programme (Mobil app.)

Control

Arm Description

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.

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.

Participants in this group will only receive an educational program

Outcomes

Primary Outcome Measures

Incremental Shuttle Walk Test (ISWT)
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).

Secondary Outcome Measures

30-Second Chair Stand Test (30 CST)
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.
Brief Physical Performance Battery (BPPB)
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)

Full Information

First Posted
January 19, 2022
Last Updated
March 8, 2023
Sponsor
Bitlis Eren University
Collaborators
Marmara University
search

1. Study Identification

Unique Protocol Identification Number
NCT05205434
Brief Title
Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges
Official Title
Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 25, 2021 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
September 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bitlis Eren University
Collaborators
Marmara University

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
Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Telerehabilitation
Keywords
COVID-19, Telerehabilitation, Exercise program, Breathing exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synchronous telerehabilitation program (Video conference)
Arm Type
Experimental
Arm Description
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.
Arm Title
Asynchronous telerehabilitation programme (Mobil app.)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group will only receive an educational program
Intervention Type
Other
Intervention Name(s)
Synchronous telerehabilitation programme
Other Intervention Name(s)
Video conference
Intervention Description
Exercise program and educational program
Intervention Type
Other
Intervention Name(s)
Asynchronous telerehabilitation programme
Other Intervention Name(s)
Mobil application
Intervention Description
Exercise program educational program
Primary Outcome Measure Information:
Title
Incremental Shuttle Walk Test (ISWT)
Description
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).
Time Frame
Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months
Secondary Outcome Measure Information:
Title
30-Second Chair Stand Test (30 CST)
Description
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.
Time Frame
Change from baseline number of sitting and staying of the patients at the end of the 8th week and, postintervation sixth months
Title
Brief Physical Performance Battery (BPPB)
Description
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)
Time Frame
Change from baseline score of the patients at the end of the 8th week and, postintervation sixth months
Other Pre-specified Outcome Measures:
Title
Oxygen Saturation and Heart Rate
Description
Participants' resting oxygen saturation and heart rate, and oxygen saturation and heart rate after the tests will be evaluated
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
Title
Dyspnea and Fatigue Level
Description
Participants' dyspnea and fatigue level, and dyspnea and fatigue level after the tests will be evaluated according to the Modified Borg (0-10) scale
Time Frame
Change from baseline dyspnea and fatigue of the patients at the end of the 8th week and, postintervation sixth months
Title
Timed Up-Go Test (TUG)
Description
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.
Time Frame
Change from baseline time (second) of the patients at the end of the 8th week and, postintervation sixth months
Title
International Physical Activity Questionnaire Short Form (IPAQ)
Description
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.
Time Frame
Change from baseline metabolic equivalent (MET)-minute/week of the patients at the end of the 8th week and, postintervation sixth months
Title
Hospital Anxiety Depression (HAD) Scale
Description
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.
Time Frame
Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
Title
Fatigue Severity Scale
Description
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.
Time Frame
Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
Title
Quality of Life Scale: Short Form-36 (SF-36)
Description
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.
Time Frame
Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdurrahman TANHAN, MSc
Organizational Affiliation
Bitlis Eren University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Maltepe
State/Province
İstanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges

We'll reach out to this number within 24 hrs