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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04473898
Other study ID # KaratayU2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 19, 2020
Est. completion date February 17, 2021

Study information

Verified date July 2020
Source KTO Karatay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate the effects of telerehabilitation program on COVID-19 symptoms, quality of life, level of depression, perception of dyspnea, sleep, fatigue, kinesiophobia and patient satisfaction in individuals diagnosed with COVID-19.


Description:

Because of the risk of infection, telerehabilitation applications are recommended for patients with COVID-19. There are no studies in the literature evaluating the effectiveness of telerehabilitation program after COVID-19. In particular, the importance of the first eight weeks after the disease was emphasized. It is thought that the telerehabilitation program will improve the functional capacities and quality of life of patients in order to adapt to the daily life after the infection more easily, to cope with the symptoms brought about by the disease more easily and to prevent the respiratory distress, intensive care stay and inactivity due to muscle weakness.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date February 17, 2021
Est. primary completion date October 19, 2020
Accepts healthy volunteers No
Gender All
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria: - volunteering to participate in the study - at least once diagnosed with COVID-19, - has a cognitive level that can adapt to online exercises, - having a physical condition suitable for exercises - staying in hospital due to covid-19 Exclusion Criteria: - refuse to participate in the study - having neurological, cardiac, respiratory disease that prevents exercise

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic Exercise Training
Aerobic exercises using all body muscles and that one can do on their own after being shown online
Behavioral:
Patient Education
Patient education about covid-19 and hygiene education
Other:
Respiratory Exercise Training
Respiratory exercises that one can do on their own after being shown online

Locations

Country Name City State
Turkey KTO Karatay University Konya Karatay

Sponsors (1)

Lead Sponsor Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dyspnoea It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea. baseline
Primary Anxiety and Depression It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). 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. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression. baseline
Primary Sleep Quality It will be evaluated by pittsburgh sleep quality index baseline
Primary Health Related Quality of Life It will be evaluated by SF-36 baseline
Primary Dyspnoea It will be evaluated by the Modified Medical Research Council (mMRC). It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea. 6 weeks later
Primary Anxiety and Depression It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). 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. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression. 6 weeks later
Primary Sleep Quality It will be evaluated by pittsburgh sleep quality index 6 weeks later
Primary Health Related Quality of Life It will be evaluated by SF-36 6 weeks later
Secondary Kinesiophobia It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement baseline
Secondary Patient Satisfaction It will be evaluated by patient satisfaction scale. Likert scale questionnaire proposed seven dimensions of patient satisfaction directed toward their doctors. These are general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Increased score indicates decreased satisfaction. The minimum score is 18, the maximum score is 90. 6 weeks later
Secondary Fatigue It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. baseline
Secondary Kinesiophobia It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement 6 weeks later
Secondary Fatigue It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. 6 weeks later
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