Short Term Results of Tele-Rehabilitation

August 28, 2023 updated by: Zeynal Yasacı, Harran University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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.

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

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.
Baseline and 6th week
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
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.
Baseline and 6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Actual)

May 20, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

May 15, 2022

First Submitted That Met QC Criteria

May 15, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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