Telerehabilitation for Patients Diagnosed With Coronavirus (COVID-19)
Primary Purpose
Telerehabilitation, Coronavirus
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
exercise brochure
Sponsored by
About this trial
This is an interventional treatment trial for Telerehabilitation focused on measuring Exercise, Breathing exercise, physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Having been diagnosed with COVID-19,
- Having been diagnosed in the last 1 week,
- Being between the ages of 18-70,
- Patients who continue to be followed at home
Exclusion Criteria:
- Hospitalization patients
- Having a serious cognitive impairment
- Having serious hearing and vision problems
Sites / Locations
- Istinye University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Group
Control Group
Arm Description
The group to which the exercise protocol consisting of breathing exercises, posture exercises, peripheral muscle training and light aerobic exercises will be applied.
group to be given an exercise brochure
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Visual Analogue Scale (VAS) is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The VAS dyspnea score uses "no shortness of breath at all" and "maximum shortness of breath" . The patient marks on the line the point that they feel represents the perception of their current state. The distance (mm) between the beginning of the horizontal line and this mark represents the degree of dyspnea perception
Modified Borg Scale
This scale used was a modified Borg scale of perceived exertion adapted to be appropriate for measuring fatigue. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. (0 = no fatigue , 10 = maximal fatigue)
Leicester Cough Questionnaire
Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score. It generally takes about 5 minutes to be completed and it is designed for adults
Timed Up and Go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require
30 Second Chair Stand Test
The 30-s Chair Stand Test consists of standing up and sitting down from a chair as many times as possible within 30 seconds. A standard chair without backrest, but with armrests is used. Initially, the person is seated on the chair with his backs upright. They are told to look forward with their arms folded in their chest and rise at their preferred speed after the command "1, 2, 3, go". All trials must be carried out using the same chair and similar environmental conditions.
The Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Two subscales include a cognitive-affective subscale and a somatic-performance subscale
The Beck Anxiety Inventory
The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults.The questions used in this measure ask about common symptoms of anxiety . It is designed for individuals who are of 17 years of age or older and takes 5 to 10 minutes to complete. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04346927
Brief Title
Telerehabilitation for Patients Diagnosed With Coronavirus
Acronym
COVID-19
Official Title
Investigation of the Effects of Exercise Using Telerehabilitation in Patients Diagnosed With Coronavirus (COVID-19) and Followed at Home
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yasemin Çırak
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
In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country. It did not take long for this epidemic to spread to the world. After that, World Health Organization declared this epidemic disease as a pandemic. As of now, the number of coronavirus deaths increased to 108,281 worldwide. Total number of cases approached 1,800,000 according to the latest information. While the number of healed patients was highest in China, 77,525 people with COVID-19 recovered.
COVID-19 is a highly contagious respiratory infectious disease that can cause respiratory, physical and psychological dysfunction in patients. Respiratory rehabilitation reduces the patient's symptoms of dyspnea, relieves anxiety and depression, reduces the patient's need to apply to the hospital, increases functional capacity and improves the patient's quality of life. Respiratory rehabilitation, according to the feedback from China, is very important for patients in the clinical treatment and recovery process after treatment. Rehabilitation of people with mild disease after discharge is mainly based on improving physical fitness and psychological adaptation. It is also aimed to gradually restore the individual's ability to the activity before the disease and return to the community as soon as possible. Individuals with COVID-19 who have respiratory and / or limb dysfunction and chronic disease after discharge should receive respiratory rehabilitation therapy. According to the current findings of the patients discharged from severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS) and the clinical experience of patients with Acute Respiratory Distress Syndrome (ARDS) patients who recovered after discharge, COVID-19 patients may have physical fitness, dyspnea after activity, and muscle atrophy. (Including respiratory muscles and trunk muscles) It is recommended to use respiratory videos and booklets as the main method for respiratory rehabilitation in isolated patients at home. Telerehabilitation method is also a different recommendation option for rehabilitation.
The purpose of this study is to investigate the effects of exercises performed by telerehabilitation in patients diagnosed with COVID-19 followed at home. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation, Coronavirus
Keywords
Exercise, Breathing exercise, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
The group to which the exercise protocol consisting of breathing exercises, posture exercises, peripheral muscle training and light aerobic exercises will be applied.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
group to be given an exercise brochure
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
15 volunteers diagnosed with coronavirus will be included in experimental group. An online exercise program has been created for individuals who will participate in the study. This program is planned to continue 3-4 days a week, in a 30-minute session and for 6 weeks. Treatment sessions will include breathing exercises, posture exercises, peripheral muscle exercises and light aerobic exercises. Individuals were asked to participate in the research via telerehabilitation connection system and were told that they would do their exercises with a physiotherapist.
Intervention Type
Other
Intervention Name(s)
exercise brochure
Intervention Description
15 volunteers diagnosed with coronavirus will be included in control group.The same exercises will be given to the control group as a brochure and they will be asked to do it for 6 weeks.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual Analogue Scale (VAS) is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The VAS dyspnea score uses "no shortness of breath at all" and "maximum shortness of breath" . The patient marks on the line the point that they feel represents the perception of their current state. The distance (mm) between the beginning of the horizontal line and this mark represents the degree of dyspnea perception
Time Frame
2 weeks
Title
Modified Borg Scale
Description
This scale used was a modified Borg scale of perceived exertion adapted to be appropriate for measuring fatigue. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. (0 = no fatigue , 10 = maximal fatigue)
Time Frame
2 weeks
Title
Leicester Cough Questionnaire
Description
Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score. It generally takes about 5 minutes to be completed and it is designed for adults
Time Frame
2 weeks
Title
Timed Up and Go
Description
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require
Time Frame
2 weeks
Title
30 Second Chair Stand Test
Description
The 30-s Chair Stand Test consists of standing up and sitting down from a chair as many times as possible within 30 seconds. A standard chair without backrest, but with armrests is used. Initially, the person is seated on the chair with his backs upright. They are told to look forward with their arms folded in their chest and rise at their preferred speed after the command "1, 2, 3, go". All trials must be carried out using the same chair and similar environmental conditions.
Time Frame
2 weeks
Title
The Beck Depression Inventory
Description
The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Two subscales include a cognitive-affective subscale and a somatic-performance subscale
Time Frame
2 weeks
Title
The Beck Anxiety Inventory
Description
The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults.The questions used in this measure ask about common symptoms of anxiety . It is designed for individuals who are of 17 years of age or older and takes 5 to 10 minutes to complete. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having been diagnosed with COVID-19,
Having been diagnosed in the last 1 week,
Being between the ages of 18-70,
Patients who continue to be followed at home
Exclusion Criteria:
Hospitalization patients
Having a serious cognitive impairment
Having serious hearing and vision problems
Facility Information:
Facility Name
Istinye University
City
İstanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telerehabilitation for Patients Diagnosed With Coronavirus
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