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Telerehabilitation After Coronavirus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04473898
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
KTO Karatay University

Brief 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.

Condition or disease Intervention/treatment Phase
COVID Other: Aerobic Exercise Training Behavioral: Patient Education Other: Respiratory Exercise Training Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is planned to include 3 groups in the study. The group 1 will be informed about covid-19 and hygiene. Aerobic exercise will be offered to Group 2, aerobic exercise + breathing exercises will be offered to Group 3. The persons to be included in the groups will be determined randomly.
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Telerehabilitation After Covid-19: Effectiveness of Respiratory and Aerobic Training
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : October 19, 2020
Estimated Study Completion Date : December 19, 2020

Arm Intervention/treatment
Sham Comparator: Patient Education Group
Information training about COViD-19 and its symptoms, hygiene education, family education
Behavioral: Patient Education
Patient education about covid-19 and hygiene education

Experimental: Aerobic Training Group
Teaching and regular follow-up of aerobic exercises shown online
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

Experimental: Aerobic + Respiratory Training Group
Teaching and regular follow-up of aerobic and respiratory exercises shown online
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




Primary Outcome Measures :
  1. Dyspnoea [ Time Frame: baseline ]
    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.

  2. Anxiety and Depression [ Time Frame: baseline ]
    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.

  3. Sleep Quality [ Time Frame: baseline ]
    It will be evaluated by pittsburgh sleep quality index

  4. Health Related Quality of Life [ Time Frame: baseline ]
    It will be evaluated by SF-36

  5. Dyspnoea [ Time Frame: 6 weeks later ]
    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. Anxiety and Depression [ Time Frame: 6 weeks later ]
    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.

  7. Sleep Quality [ Time Frame: 6 weeks later ]
    It will be evaluated by pittsburgh sleep quality index

  8. Health Related Quality of Life [ Time Frame: 6 weeks later ]
    It will be evaluated by SF-36


Secondary Outcome Measures :
  1. Kinesiophobia [ Time Frame: baseline ]
    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

  2. Patient Satisfaction [ Time Frame: 6 weeks later ]
    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.

  3. Fatigue [ Time Frame: baseline ]
    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.

  4. Kinesiophobia [ Time Frame: 6 weeks later ]
    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

  5. Fatigue [ Time Frame: 6 weeks later ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473898


Contacts
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Contact: Büşra Alkan, MsC, PT, RA +90 332 44 1251 ext 7659 busra.alkan@karatay.edu.tr
Contact: Melike Akdam, PT, RA +90 4441251 ext 7893 melike.akdam@karatay.edu.tr

Locations
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Turkey
KTO Karatay University Recruiting
Konya, Karatay, Turkey, 42030
Contact: Büşra Alkan, MsC, PT,RA    +90 0332 444 1251 ext 7659    busra.alkan@karatay.edu.tr   
Contact: Melike Akdam, PT, RA    +90 0332 444 1251 ext 7893    melike.akdam@karatay.edu.tr   
Sponsors and Collaborators
KTO Karatay University
Investigators
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Study Director: Özlem Akkoyun Sert, Phd, PT KTO Karatay University
Study Chair: Kamil Yılmaz, Phd, PT KTO Karatay University
Study Chair: Osman Karaca, MsC,PT KTO Karatay University
Study Chair: Hasan Gerçek, PT KTO Karatay University
Study Chair: Bayram Sönmez Ünüvar, MsC, PT KTO Karatay University
Study Chair: Sinan Bağçacı, Dr KTO Karatay University
Study Chair: Büşra Alkan, MsC, PT, RA KTO Karatay University
Study Chair: Melike Akdam, PT, RA KTO Karatay University
Study Chair: Buse Kılınç, PT KTO Karatay University
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Responsible Party: KTO Karatay University
ClinicalTrials.gov Identifier: NCT04473898    
Other Study ID Numbers: KaratayU2
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KTO Karatay University:
Covid-19
Telerehabilitation
Respiratory Exercises
Aerobic Exercises