Short Term Results of Tele-Rehabilitation

Sponsor
Harran University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05381675
Collaborator
(none)
60
1
2
3.4
17.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Tele-rehabillitation
  • Other: Prescribed Exercise Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Short Term Outcomes of Tele-Rehabilitation in Patients With Post-Covid Syndrome
Actual Study Start Date :
May 20, 2022
Anticipated Primary Completion Date :
Aug 20, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Participants will receive a supervised tele-rehabilitation program 2 days a week for 6 weeks.

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

Other: Control

Participants will receive the same rehabilitation program as prescribed.

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Change from the baseline to the 6th week in mMRC (Modified Medical Research Council) Dyspnoea Scale [Baseline and 6th week]

    The mMRC Dyspnoea Scale is used to assess the degree of baseline functional disability due to dyspnoea

Secondary Outcome Measures

  1. Change from the baseline to the 6th week in NPRS [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.

  2. Change from the baseline to the 6th week in the 5 times sit to stand test (5XSST) [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.

  3. Change from the baseline to the 6th week in the Hospital Anxiety and Depression Scale [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.

  4. Change from the baseline to the 6th week in the The Pittsburgh Sleep Quality Index [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 İstanbul University-Cerrahpasa Istanbul Turkey

Sponsors and Collaborators

  • Harran University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeynal Yasacı, Research Assistant, Harran University
ClinicalTrials.gov Identifier:
NCT05381675
Other Study ID Numbers:
  • İntervention
First Posted:
May 19, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zeynal Yasacı, Research Assistant, Harran University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022