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Telerehabilitation in COVID-19 Survivors

Primary Purpose

COVID-19, Telerehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
telerehabilitation
home exercise program
informed program
Sponsored by
Bandırma Onyedi Eylül University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring COVID-19, telerehabilitation, COVID-19 Survivors, functional capacity, pulmonary functions, peripheral muscle oxygenation, home workout program

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with COVID-19 by Computed Tomography (CT) or PCR test between the ages of 18-75,
  • Do not have any orthopedic or neurological disease that will affect exercise capacity,
  • Individuals who can take and execute verbal orders,
  • Have had COVID-19 and at least 2 weeks have passed since the completion of the treatment,
  • Individuals who have a computer or smart phone with a camera and internet connection and have the ability to use it (the participant himself or one of his family members living in the same house),
  • Individuals who are sedentary (those whose physical activity level is inactive according to the Turkish version of the International Physical Activity Questionnaire (UFAA)),
  • Having dyspnea at level 2 or 3 on the Medical Research Council Dyspnea Scale.

Exclusion Criteria:

  • Those who have not had COVID-19 or acute period patients who are experiencing COVID-19,
  • Individuals who cannot be contacted,
  • Individuals with chronic heart disease,
  • Those with concomitant uncontrolled disease; uncontrolled hypertension (resting blood pressure ≥160 /100mmHg), uncontrolled diabetes (random instantaneous blood glucose>16.7 mmol/l, HbA1C>7.0%),
  • Those with concomitant severe organic disease (unstable hemodynamic heart disease, heart failure causing movement limitation, unstable angina, MI or other cardiac disease in the last 12 years),
  • Individuals with cerebrovascular disease in the last 6 months,
  • Those with digestive system ulcer, thyroid dysfunction or active stage of tuberculosis,
  • Patients with Chronic Kidney Failure stage 3 and above according to Glomerular Filtration Rate (GFR),
  • Individuals who have undergone intraraticular medication or surgery from their lower extremities in the last 6 months,
  • Individuals who cannot walk independently,
  • Individuals with any mental illness that may prevent them from living independently or receiving treatment,
  • Uncooperative individuals for assessment and rehabilitation programs,
  • Those with alcohol or substance addiction,
  • Those who are pregnant, suspected of pregnancy or considering becoming pregnant,
  • Participants in another study within the last 3 months or currently.

Sites / Locations

  • Bandırma Onyedi Eylül University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

control group

home exercise program group

telerehabilitation group

Arm Description

While other groups continue their exercise program for 6 weeks, this group will only be informed after COVID 19.

this group will implement COVID 19 home exercise program.

this group will implement COVID 19 telerehabilitation program.

Outcomes

Primary Outcome Measures

Severity of dyspnea assessment
Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
Physical activity level assessment
The physical activity level of the participants will be evaluated with the Turkish version of the "International Physical Activity Questionnaire" (UFAA).In the last 7 days with the survey; Vigorous physical activity (football, basketball, aerobics, cycling fast, lifting weights, carrying loads, etc.) time (min), Intermediate physical activity (light weight carrying, cycling at normal speed, folk dances, dancing, bowling, table tennis etc.) duration (min), walking and sitting times for one day (min) are questioned. All participants were given pre-study to assess the condition of being sedentary and those with inactive physical activity levels will be included in the study.
Cardiopulmonary endurance assessment
In order to evaluate cardiopulmonary endurance; A six-minute walking test will be applied. The test is 30 meters long, every 3 meters marked, the start and finish line are marked by a visible line, a smooth and straight done on the track. The distance the person walks for 6 minutes is recorded in meters.
Evaluation of peripheral muscle oxygenation
"Moxy muscle oxygen monitor" will be used to measure regional oxygen saturation (SmO2) and total hemoglobin (Thb) amount in capillaries under the muscle. Moxy muscle oxygen monitor (Fortiori Design LLC, USA) near infrared It is placed on the skin in a non-invasive way with spectroscopy (NIRS), It is a device that regional blood flow and measures oxygenation. A moxy muscle oxygen monitor will be attached to the quadriceps femoris muscle of the participants with a velcro and oxygenation measurements will be taken during both the dinelnim and 6-minute walking test.
Pulmonary function (slow vital capacity)
Single Breath Count Test will be used to evaluate slow vital capacity (the amount of air exhaled with slow exhalation after deep and maximal inspiration) and lung function. Single breath count (TNS), after maximal effort inhalation an individual with a metronome set to 2 beats per second in a normal speaking voice. It is a measure of how much you can count in your cadence.
Pulmonary function (Forced vital capacity (FVC))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.
Activities of daily living assessment
Barthel Index will be used to evaluate activities of daily living.
Muscle strength assessment
Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.
Perceived fatigue assessment
Participants' perceived fatigue level will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers. consists of corresponding definitions It will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers consists of corresponding definitions. The Borg Scale is a subjective scale used to evaluate muscle fatigue.
General fatigue assessment
Participants will be asked to answer the chalder fatigue scale, which includes 11 questions about their fatigue in the past month. The maximum total score is 33; 4 and above scorers are described as tired.
Quality of life assessment
The Short Form-12 (SF-12) Questionnaire will be used to assess the quality of life.When scoring, two scores are obtained, the physical component and the mental component summary. is done. High scores indicate good health.
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
Pulmonary function (Peak flow rate (PEF)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2021
Last Updated
March 13, 2023
Sponsor
Bandırma Onyedi Eylül University
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1. Study Identification

Unique Protocol Identification Number
NCT05074979
Brief Title
Telerehabilitation in COVID-19 Survivors
Official Title
Determining the Effectiveness of Telerehabilitation in COVID-19 Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bandırma Onyedi Eylül 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
This study was carried out in the post-acute period of the telerehabilitation program in individuals with dyspnea who had COVID-19; It will be done to examine the effects on dyspnea, exercise capacity, respiratory functions, activities of daily living, muscle strength, muscle oxygenation, fatigue and quality of life parameters.

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, COVID-19 Survivors, functional capacity, pulmonary functions, peripheral muscle oxygenation, home workout program

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
While other groups continue their exercise program for 6 weeks, this group will only be informed after COVID 19.
Arm Title
home exercise program group
Arm Type
Experimental
Arm Description
this group will implement COVID 19 home exercise program.
Arm Title
telerehabilitation group
Arm Type
Experimental
Arm Description
this group will implement COVID 19 telerehabilitation program.
Intervention Type
Other
Intervention Name(s)
telerehabilitation
Intervention Description
While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
Intervention Type
Other
Intervention Name(s)
home exercise program
Intervention Description
While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
Intervention Type
Other
Intervention Name(s)
informed program
Intervention Description
will informed after COVID 19
Primary Outcome Measure Information:
Title
Severity of dyspnea assessment
Description
Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
Time Frame
6 weeks
Title
Physical activity level assessment
Description
The physical activity level of the participants will be evaluated with the Turkish version of the "International Physical Activity Questionnaire" (UFAA).In the last 7 days with the survey; Vigorous physical activity (football, basketball, aerobics, cycling fast, lifting weights, carrying loads, etc.) time (min), Intermediate physical activity (light weight carrying, cycling at normal speed, folk dances, dancing, bowling, table tennis etc.) duration (min), walking and sitting times for one day (min) are questioned. All participants were given pre-study to assess the condition of being sedentary and those with inactive physical activity levels will be included in the study.
Time Frame
6 weeks
Title
Cardiopulmonary endurance assessment
Description
In order to evaluate cardiopulmonary endurance; A six-minute walking test will be applied. The test is 30 meters long, every 3 meters marked, the start and finish line are marked by a visible line, a smooth and straight done on the track. The distance the person walks for 6 minutes is recorded in meters.
Time Frame
6 weeks
Title
Evaluation of peripheral muscle oxygenation
Description
"Moxy muscle oxygen monitor" will be used to measure regional oxygen saturation (SmO2) and total hemoglobin (Thb) amount in capillaries under the muscle. Moxy muscle oxygen monitor (Fortiori Design LLC, USA) near infrared It is placed on the skin in a non-invasive way with spectroscopy (NIRS), It is a device that regional blood flow and measures oxygenation. A moxy muscle oxygen monitor will be attached to the quadriceps femoris muscle of the participants with a velcro and oxygenation measurements will be taken during both the dinelnim and 6-minute walking test.
Time Frame
6 weeks
Title
Pulmonary function (slow vital capacity)
Description
Single Breath Count Test will be used to evaluate slow vital capacity (the amount of air exhaled with slow exhalation after deep and maximal inspiration) and lung function. Single breath count (TNS), after maximal effort inhalation an individual with a metronome set to 2 beats per second in a normal speaking voice. It is a measure of how much you can count in your cadence.
Time Frame
6 weeks
Title
Pulmonary function (Forced vital capacity (FVC))
Description
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
Time Frame
6 weeks
Title
Respiratory Muscle Strength
Description
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.
Time Frame
6 weeks
Title
Activities of daily living assessment
Description
Barthel Index will be used to evaluate activities of daily living.
Time Frame
6 weeks
Title
Muscle strength assessment
Description
Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.
Time Frame
6 weeks
Title
Perceived fatigue assessment
Description
Participants' perceived fatigue level will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers. consists of corresponding definitions It will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers consists of corresponding definitions. The Borg Scale is a subjective scale used to evaluate muscle fatigue.
Time Frame
6 weeks
Title
General fatigue assessment
Description
Participants will be asked to answer the chalder fatigue scale, which includes 11 questions about their fatigue in the past month. The maximum total score is 33; 4 and above scorers are described as tired.
Time Frame
6 weeks
Title
Quality of life assessment
Description
The Short Form-12 (SF-12) Questionnaire will be used to assess the quality of life.When scoring, two scores are obtained, the physical component and the mental component summary. is done. High scores indicate good health.
Time Frame
6 weeks
Title
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Description
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Time Frame
6 weeks
Title
Pulmonary function (FEV1 / FVC)
Description
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
Time Frame
6 weeks
Title
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Description
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
Time Frame
6 weeks
Title
Pulmonary function (Peak flow rate (PEF)
Description
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.
Time Frame
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: Diagnosed with COVID-19 by Computed Tomography (CT) or PCR test between the ages of 18-75, Do not have any orthopedic or neurological disease that will affect exercise capacity, Individuals who can take and execute verbal orders, Have had COVID-19 and at least 2 weeks have passed since the completion of the treatment, Individuals who have a computer or smart phone with a camera and internet connection and have the ability to use it (the participant himself or one of his family members living in the same house), Individuals who are sedentary (those whose physical activity level is inactive according to the Turkish version of the International Physical Activity Questionnaire (UFAA)), Having dyspnea at level 2 or 3 on the Medical Research Council Dyspnea Scale. Exclusion Criteria: Those who have not had COVID-19 or acute period patients who are experiencing COVID-19, Individuals who cannot be contacted, Individuals with chronic heart disease, Those with concomitant uncontrolled disease; uncontrolled hypertension (resting blood pressure ≥160 /100mmHg), uncontrolled diabetes (random instantaneous blood glucose>16.7 mmol/l, HbA1C>7.0%), Those with concomitant severe organic disease (unstable hemodynamic heart disease, heart failure causing movement limitation, unstable angina, MI or other cardiac disease in the last 12 years), Individuals with cerebrovascular disease in the last 6 months, Those with digestive system ulcer, thyroid dysfunction or active stage of tuberculosis, Patients with Chronic Kidney Failure stage 3 and above according to Glomerular Filtration Rate (GFR), Individuals who have undergone intraraticular medication or surgery from their lower extremities in the last 6 months, Individuals who cannot walk independently, Individuals with any mental illness that may prevent them from living independently or receiving treatment, Uncooperative individuals for assessment and rehabilitation programs, Those with alcohol or substance addiction, Those who are pregnant, suspected of pregnancy or considering becoming pregnant, Participants in another study within the last 3 months or currently.
Facility Information:
Facility Name
Bandırma Onyedi Eylül University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
City
Balıkesir
State/Province
Bandırma
ZIP/Postal Code
10200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telerehabilitation in COVID-19 Survivors

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