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The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients

Primary Purpose

Covid19, Telerehabilitation, Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring exercise, videoconference

Eligibility Criteria

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

Inclusion Criteria:

  • Being between the ages of 18-75
  • Being diagnosed with COVID19 and being discharged by being treated
  • Having technological facilities suitable for telerehabilitation access

Exclusion Criteria:

  • Any presence of comorbidity that may prevent them from exercising
  • Not agreeing to be included in the study

Sites / Locations

  • University of Health Sciences Turkey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telerehabilitation Group

Control group

Arm Description

Physiotherapy will be carried out by conducting online conference method. Program content; Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking

Information and exercise brochure will be provided

Outcomes

Primary Outcome Measures

Modified Medical Research Council Dyspnea Score
The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.
Timed up and go test
The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
Visual analog scale to assess the pain severity
Visual analog scale to assess the pain on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
The Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing
Visual analog scale to assess the fatigue severity
Visual analog scale to assess the fatigue severity on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.

Secondary Outcome Measures

BECK depression inventory
This is a 21-item self-assessment scale designed by Aaron Beck in 1961 to measure the risk and level of depression.
Saint George Respiratory Questionnaire
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)

Full Information

First Posted
May 22, 2020
Last Updated
December 11, 2020
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04402983
Brief Title
The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients
Official Title
The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

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
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases.
Detailed Description
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases. The exercise program will be a total of 6 weeks, 3 days a week. Online access will be carried out synchronously by telephone or computer, and training sessions will not be recorded in order to protect patient personal information. The cases will be evaluated online at the beginning of the study and at the end of the 6-week exercise program. The selected evaluation parameters have been selected considering the ease of online application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Telerehabilitation, Physical Therapy
Keywords
exercise, videoconference

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation Group
Arm Type
Experimental
Arm Description
Physiotherapy will be carried out by conducting online conference method. Program content; Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Information and exercise brochure will be provided
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Program content Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking
Primary Outcome Measure Information:
Title
Modified Medical Research Council Dyspnea Score
Description
The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.
Time Frame
Baseline to 6 weeks
Title
Timed up and go test
Description
The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
Time Frame
Baseline to 6 weeks
Title
Visual analog scale to assess the pain severity
Description
Visual analog scale to assess the pain on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
Time Frame
Baseline to 6 weeks
Title
The Short Physical Performance Battery (SPPB)
Description
The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing
Time Frame
Baseline to 6 weeks
Title
Visual analog scale to assess the fatigue severity
Description
Visual analog scale to assess the fatigue severity on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
BECK depression inventory
Description
This is a 21-item self-assessment scale designed by Aaron Beck in 1961 to measure the risk and level of depression.
Time Frame
Baseline to 6 weeks
Title
Saint George Respiratory Questionnaire
Description
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Time Frame
Baseline to 6 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: Being between the ages of 18-75 Being diagnosed with COVID19 and being discharged by being treated Having technological facilities suitable for telerehabilitation access Exclusion Criteria: Any presence of comorbidity that may prevent them from exercising Not agreeing to be included in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Pehlivan, PhD
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences Turkey
City
İstanbul
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35651892
Citation
Pehlivan E, Palali I, Atan SG, Turan D, Cinarka H, Cetinkaya E. The effectiveness of POST-DISCHARGE telerehabilitation practices in COVID-19 patients: Tele-COVID study-randomized controlled trial. Ann Thorac Med. 2022 Apr-Jun;17(2):110-117. doi: 10.4103/atm.atm_543_21. Epub 2022 Apr 19.
Results Reference
derived

Learn more about this trial

The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients

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