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
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Other: Telerehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Aslihan Cakmak, MSc, PT||903123051576 ext email@example.com|
|Contact: Esra Kinaci, MSc, PT||903123051576 ext firstname.lastname@example.org|
|Contact: Aslihan Cakmak, MSc email@example.com|
|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|