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Effects of Telerehabilitation After Discharge in COVID-19 Survivors

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ClinicalTrials.gov Identifier: NCT04794374
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Aslihan Cakmak, Hacettepe University

Brief Summary:
Effects of telerehabilitation after discharge on quality of Life, psychosocial status, physical activity, daily activities of living, and sleep quality in patients treated as inpatients with the diagnosis of COVID-19 will be investigated. Post-discharge physical activity level, psychosocial status, sleep quality, quality of life, daily activities of living, and quality of life will be determined. The effects of exercise interventions in online-based physiotherapist monitoring will be provided. Monthly comparisons of physical activity, quality of life, depression, and sleep quality responses using telerehabilitation for three months following COVID-19 will be investigated.

Condition or disease Intervention/treatment Phase
Covid19 Other: Telerehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Telerehabilitation After Discharge on Quality of Life, Psychosocial Status, Physical Activity, Daily Activities of Living, and Sleep Quality in Patients Treated as Inpatients With the Diagnosis of COVID-19
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : January 16, 2022
Estimated Study Completion Date : January 16, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Discharged COVID-19 survivors

Telerehabilitation will be provided by physiotherapists including audio, video visits.

A brochure designed by physiotherapists for COVID-19 survivors will be used. Physiotherapists will call patients weekly and guide, design, modify the exercises accordingly to the patients.

Other: Telerehabilitation
Telerehabilitation will consists of physiotherapist-guided exercises. Exercises will be designed by physiotherapists for COVID-19 survivors using the current guidelines. Exercise brochure will be prepared and will be sent to participants. Repetitions and sets of exercises will be modified according to the patients.




Primary Outcome Measures :
  1. Physical activity level [ Time Frame: up to 6 months ]
    Turkish version of the International Physical Activity Questionnaire (IPAQ) short form will be used for the assessment of physical activity. The IPAQ short form is a questionnaire consisting of seven questions used to evaluate the level of physical activity in people aged 18-69 years. Walking, moderate activity duration, and vigorous activity duration are the sub-parameters of the questionnaire. The sitting time is evaluated separately. The total score of the questionnaire is obtained by the sum of the products of metabolic equivalent (MET), activity duration (minutes) and frequency (days) corresponding to the activity. The questionnaire has Turkish validity and reliability.

  2. Psychosocial status [ Time Frame: up to 6 months ]
    Psychosocial status will be evaluated using the Turkish version of Hospital Anxiety and Depression Scale (HADS). HADS will be used to assess the level of anxiety and depression. This scale is a 14-item self-report scale that aims to determine the risk in terms of anxiety and depression in the patient, and measure its level and change in severity. The scale, which was asked to be answered considering the last few days, has two subscales, consisting of seven items measuring anxiety and seven items measuring depression. Higher scores indicate better psychosocial status.

  3. Sleep quality [ Time Frame: up to 6 months ]
    Evaluation of sleep quality will be assessed using Pittsburgh Sleep Quality Index (PSQI). PSQI is a self-report scale that evaluates sleep quality and sleep disturbance over a one-month period. PSQI includes seven components and 19 questions. The components include perceived sleep quality, sleep delay (how long it takes to fall asleep), sleep time, habitual sleep activity (how much a person is asleep compared to the time spent in bed), sleep disturbances (noise, temperature, pain, nocturia), sleep medications, and daytime dysfunction (drowsiness, concentration). The total score ranges from 0 to 21. A score higher than five indicates sleep disorder. The Turkish validity and reliability study of this questionnaire was conducted.

  4. Health related quality of life [ Time Frame: up to 6 months ]
    Nottingham Health Profile (NHP) will be used to assess quality of life. This questionnaire is a general quality of life scale developed to measure perceived health problems and the extent to which these problems affect normal daily activities. The scale assesses the perceived restriction or discomfort in 6 sub-sections: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items). There are 38 items. There is a possible score limit ranging from 0-100 for each subsection. "0 points" indicates that there is no restriction. "100 points" indicates the presence of all restrictions listed. There is a Turkish validity and reliability study of the NHP.

  5. Activities of daily living [ Time Frame: up to 6 months ]
    The Barthel Index basically evaluates mobility and self-care activities. It consists of 10 sub-headings: eating, bathing, self-care, dressing, bladder control, bowel control, toilet use, chair / bed transfer, mobility, and use of stairs. The total score ranges from 0 to 100. "0" points total addiction; A score of "100" indicates complete independence. The Barthel Index has Turkish validity and reliability.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being clinically stable,
  • Being 18 years old or older
  • Being a volunteer for the study and providing their consent,
  • Able to read and write
  • Having a smart phone and being able to use it

Exclusion Criteria:

  • Having unstable clinical condition
  • Having severe neuromuscular and musculoskeletal problems,
  • Being unable to cooperate and respond to the questionnaires and scales
  • Not being a volunteer to participate

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): NCT04794374


Contacts
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Contact: Aslihan Cakmak, MSc, PT 903123051576 ext 178 aslihancakmak90@gmail.com
Contact: Esra Kinaci, MSc, PT 903123051576 ext 175 kncesra@gmail.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey
Contact: Aslihan Cakmak, MSc       aslihancakmak90@gmail.com   
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Chair: Lale Ozisik, Assoc.Prof. Hacettepe University
Study Chair: Nursel Calik Basaran, Asst.Prof Hacettepe University
Principal Investigator: Oguz Abdullah Uyaroglu, Asst.Prof Hacettepe University
Study Chair: Deniz Inal-Ince, Prof. Hacettepe University
Study Chair: Naciye Vardar-Yagli, Assoc.Prof. Hacettepe University
Study Chair: Melda Saglam, Assoc.Prof. Hacettepe University
Principal Investigator: Ebru Calik-Kutukcu, Assoc.Prof. Hacettepe University
Principal Investigator: Esra Kinaci, MSc, PT. Hacettepe University
Study Director: Gulay Sain Guven, Prof. Hacettepe University
Principal Investigator: Aslihan Cakmak, MSc, PT. Hacettepe University
Publications:
COVID-19 (SARS-CoV2) Enfeksiyonu Rehberi (Bilim Kurulu Çalışması). T.C. Sağlık Bakanlığı. Halk Sağlığı Genel Müdürlüğü. T.C. Sağlık Bakanlığı. (https://covid19bilgi.saglik.gov.tr/depo/rehberler/COVID-19_Rehberi.pdf) Erişim Tarihi: 19 Mayıs 2020.
İnal İnce D, Vardar Yağlı N, Sağlam M, Çalık Kütükcü E. COVID-19 Enfeksiyonunda Akut ve Post-Akut Fizyoterapi ve Rehabilitasyon. Turk J Physiother Rehabil. 2020;31(1):81-93.
World Health Organization. Global recommendations for physical activity and health. Geneva: WHO Press; 2010.
Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlilik ve Güvenilirlik Çalışması Türk Psikiyatri Derg. 1997;8(4):280-7.
Ağargün MY, Kara H, Anlar Ö. Pittsburgh Uyku Kalite İndeksinin Geçerliği ve Güvenirliği. Türk Psikiyatri Derg. 1996;7(2):107-15.

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Responsible Party: Aslihan Cakmak, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT04794374    
Other Study ID Numbers: KA-20085
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
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 Aslihan Cakmak, Hacettepe University:
telerehabilitation
physical activity
sleep quality
post COVID-19
quality of life