Effects of Telerehabilitation After Discharge in COVID-19 Survivors

NCT04794374 | Completed

• 1 other identifier: KA-20085
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

telerehabilitation; physical activity; sleep quality; post COVID-19; quality of life

Outcome Measures

Primary Outcomes (5)

• Physical activity level

  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.

  up to 6 months

• Psychosocial status

  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.

  up to 6 months

• Sleep quality

  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.

  up to 6 months

• Health related quality of life

  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.

  up to 6 months

• Activities of daily living

  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.

  up to 6 months

Study Arms (1)

Discharged COVID-19 survivors

EXPERIMENTAL

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

Interventions

Telerehabilitation OTHER

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.

Discharged COVID-19 survivors

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (21)

• 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.

  BACKGROUND

• Mohamed AA, Alawna M. Role of increasing the aerobic capacity on improving the function of immune and respiratory systems in patients with coronavirus (COVID-19): A review. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):489-496. doi: 10.1016/j.dsx.2020.04.038. Epub 2020 Apr 28.

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  BACKGROUND

• Ambrosino N, Fracchia C. The role of tele-medicine in patients with respiratory diseases. Expert Rev Respir Med. 2017 Nov;11(11):893-900. doi: 10.1080/17476348.2017.1383898. Epub 2017 Sep 27.

  PMID: 28942692 BACKGROUND

• Galea MD. Telemedicine in Rehabilitation. Phys Med Rehabil Clin N Am. 2019 May;30(2):473-483. doi: 10.1016/j.pmr.2018.12.002. Epub 2019 Mar 5.

  PMID: 30954160 BACKGROUND

• Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/

  PMID: 26180873 BACKGROUND

• Pecanha T, Goessler KF, Roschel H, Gualano B. Social isolation during the COVID-19 pandemic can increase physical inactivity and the global burden of cardiovascular disease. Am J Physiol Heart Circ Physiol. 2020 Jun 1;318(6):H1441-H1446. doi: 10.1152/ajpheart.00268.2020. Epub 2020 May 15.

  PMID: 32412779 BACKGROUND

• Altena E, Baglioni C, Espie CA, Ellis J, Gavriloff D, Holzinger B, Schlarb A, Frase L, Jernelov S, Riemann D. Dealing with sleep problems during home confinement due to the COVID-19 outbreak: Practical recommendations from a task force of the European CBT-I Academy. J Sleep Res. 2020 Aug;29(4):e13052. doi: 10.1111/jsr.13052. Epub 2020 May 4.

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• Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30.

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• Sheehy LM. Considerations for Postacute Rehabilitation for Survivors of COVID-19. JMIR Public Health Surveill. 2020 May 8;6(2):e19462. doi: 10.2196/19462.

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  BACKGROUND

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• Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.

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MeSH Terms

Conditions

COVID-19; Motor Activity; Sleep Initiation and Maintenance Disorders

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Lale Ozisik, Assoc.Prof.

  Hacettepe University

  STUDY CHAIR

• Nursel Calik Basaran, Asst.Prof

  Hacettepe University

  STUDY CHAIR

• Oguz Abdullah Uyaroglu, Asst.Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Deniz Inal-Ince, Prof.

  Hacettepe University

  STUDY CHAIR

• Naciye Vardar-Yagli, Assoc.Prof.

  Hacettepe University

  STUDY CHAIR

• Melda Saglam, Assoc.Prof.

  Hacettepe University

  STUDY CHAIR

• Ebru Calik-Kutukcu, Assoc.Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Esra Kinaci, MSc, PT.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Gulay Sain Guven, Prof.

  Hacettepe University

  STUDY DIRECTOR

• Aslihan Cakmak, MSc, PT.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: November 16, 2020
• Primary Completion: October 27, 2021
• Study Completion: March 31, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)