Short Term Results of Tele-Rehabilitation

COVID-19 Clinical Trial

Official title:

Short Term Outcomes of Tele-Rehabilitation in Patients With Post-Covid Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381675
• Other study ID #: Intervention
• Status: Completed
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Harran University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Dyspnea

Intervention

Other:
• Tele-rehabillitation
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
• Prescribed Exercise Program
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

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Harran University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 6th week
Secondary	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.	Baseline and 6th week
Secondary	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.	Baseline and 6th week
Secondary	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.	Baseline and 6th week
Secondary	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.	Baseline and 6th week