- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05381675
Short Term Results of Tele-Rehabilitation
Short Term Outcomes of Tele-Rehabilitation in Patients With Post-Covid Syndrome
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Istanbul University-Cerrahpasa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participants will receive a supervised tele-rehabilitation program 2 days a week for 6 weeks.
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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 |
Other: Control
Participants will receive the same rehabilitation program as prescribed.
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from the baseline to the 6th week in mMRC (Modified Medical Research Council) Dyspnoea Scale
Time Frame: Baseline and 6th week
|
The mMRC Dyspnoea Scale is used to assess the degree of baseline functional disability due to dyspnoea
|
Baseline and 6th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from the baseline to the 6th week in NPRS
Time Frame: Baseline and 6th week
|
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.
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Baseline and 6th week
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Change from the baseline to the 6th week in the 5 times sit to stand test (5XSST)
Time Frame: Baseline and 6th week
|
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.
|
Baseline and 6th week
|
Change from the baseline to the 6th week in the Hospital Anxiety and Depression Scale
Time Frame: Baseline and 6th week
|
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.
|
Baseline and 6th week
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Change from the baseline to the 6th week in the The Pittsburgh Sleep Quality Index
Time Frame: Baseline and 6th week
|
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.
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Baseline and 6th week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- İntervention
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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