Back to resultsShort Term Results of Tele-Rehabilitation
Primary Purpose
COVID-19, Dyspnea
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tele-rehabillitation
Prescribed Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Tele-rehabilitation, COVID-19
Eligibility Criteria
Inclusion Criteria:
- Being between the ages of 18-75,
- Being in stable medical condition, conscious and cooperative,
- Having had COVID and continuing symptoms
- Volunteering to participate in the study,
- Own a device that can be connected online independently or with support from family members.
Exclusion Criteria:
SpO2 < 92%,
- Hypotension (Systolic Blood Pressure < 90 mmHg or Diastolic Blood Pressure < 60mmHg)
- Having chronic respiratory disease (COPD, Asthma, etc.)
- Having a stroke or neurodegenerative disease.
- Not being willing to participate in the study
Sites / Locations
- İstanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
Participants will receive a supervised tele-rehabilitation program 2 days a week for 6 weeks.
Participants will receive the same rehabilitation program as prescribed.
Outcomes
Primary Outcome Measures
Change from the baseline to the 6th week in mMRC (Modified Medical Research Council) Dyspnoea Scale
The mMRC Dyspnoea Scale is used to assess the degree of baseline functional disability due to dyspnoea
Secondary Outcome Measures
Change from the baseline to the 6th week in NPRS
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Change from the baseline to the 6th week in the 5 times sit to stand test (5XSST)
The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The equipment need in performing 5XSST test includes: Stopwatch and standard height chair with straight back.
Change from the baseline to the 6th week in the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) was devised to measure anxiety and depression in a general medical population of patients. The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately.
Change from the baseline to the 6th week in the The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a measure of self-reported sleep quality and sleep disturbance. Scoring Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "some- times," 2 = "often," and 3 = "almost always"). The PSQI takes about 10 minutes to complete and it doesn't involve any procedures or interventions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05381675
Brief Title
Short Term Results of Tele-Rehabilitation
Official Title
Short Term Outcomes of Tele-Rehabilitation in Patients With Post-Covid Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Most people who have coronavirus disease (COVID-19) recover completely without any sequelae. However, some patients continue to experience symptoms of COVID-19 even though their tests turn negative. This clinical spectrum that occurs after acute infection is called the post-COVID syndrome (PCS). Dyspnea, pain, decreased exercise capacity, limitations in activities of daily living, poor sleep quality, anxiety and depression are common symptoms in PCS. The aim of our study is to examine the effect of tele-rehabilitation-based exercise program on dyspnea, pain, functional capacity, sleep quality, anxiety and depression in individuals with PCS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Dyspnea
Keywords
Tele-rehabilitation, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive a supervised tele-rehabilitation program 2 days a week for 6 weeks.
Arm Title
Control
Arm Type
Other
Arm Description
Participants will receive the same rehabilitation program as prescribed.
Intervention Type
Other
Intervention Name(s)
Tele-rehabillitation
Intervention Description
Tele-rehabilitation program will be performed by physiotherapist two times a week for six consecutive weeks. Program including the following exercises:
Breathing exercises Aerobic exercises Flexibility Strengthening exercises
Intervention Type
Other
Intervention Name(s)
Prescribed Exercise Program
Intervention Description
The prescribed exercise program will be performed two times a week for six consecutive weeks. Program including the following exercises:
Breathing exercises Aerobic exercises Flexibility Strengthening exercises
Primary Outcome Measure Information:
Title
Change from the baseline to the 6th week in mMRC (Modified Medical Research Council) Dyspnoea Scale
Description
The mMRC Dyspnoea Scale is used to assess the degree of baseline functional disability due to dyspnoea
Time Frame
Baseline and 6th week
Secondary Outcome Measure Information:
Title
Change from the baseline to the 6th week in NPRS
Description
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Time Frame
Baseline and 6th week
Title
Change from the baseline to the 6th week in the 5 times sit to stand test (5XSST)
Description
The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The equipment need in performing 5XSST test includes: Stopwatch and standard height chair with straight back.
Time Frame
Baseline and 6th week
Title
Change from the baseline to the 6th week in the Hospital Anxiety and Depression Scale
Description
The Hospital Anxiety and Depression Scale (HADS) was devised to measure anxiety and depression in a general medical population of patients. The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately.
Time Frame
Baseline and 6th week
Title
Change from the baseline to the 6th week in the The Pittsburgh Sleep Quality Index
Description
The Pittsburgh Sleep Quality Index (PSQI) is a measure of self-reported sleep quality and sleep disturbance. Scoring Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "some- times," 2 = "often," and 3 = "almost always"). The PSQI takes about 10 minutes to complete and it doesn't involve any procedures or interventions.
Time Frame
Baseline and 6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Being between the ages of 18-75,
Being in stable medical condition, conscious and cooperative,
Having had COVID and continuing symptoms
Volunteering to participate in the study,
Own a device that can be connected online independently or with support from family members.
Exclusion Criteria:
SpO2 < 92%,
Hypotension (Systolic Blood Pressure < 90 mmHg or Diastolic Blood Pressure < 60mmHg)
Having chronic respiratory disease (COPD, Asthma, etc.)
Having a stroke or neurodegenerative disease.
Not being willing to participate in the study
Facility Information:
Facility Name
İstanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Short Term Results of Tele-Rehabilitation
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