Effects of Telerehabilitation After Discharge in COVID-19 Survivors

Sponsor

Hacettepe University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04794374

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

The new type of Coronavirus (SARS-CoV-2) has progressed rapidly in our country and around the world and has caused a global health emergency, requiring the implementation of restrictive measures. While the origin of SARS-CoV-2 is still under investigation, the available information points to wild animals sold illegally in the Wuhan Seafood Wholesale Market. Common symptoms of infection are fever, cough, and dyspnea. In more severe cases, pneumonia, severe acute respiratory tract infection, renal failure, and even death may occur. Up-to-date information about physiotherapy and rehabilitation applications on COVID-19 disease is limited to positioning and mobilization in the acute phase of the disease. Current guidelines and protocols state that airway clearance techniques, respiratory exercises and practices using assistive devices, exercise training and respiratory muscle training should not be applied in the acute period. Tele-medicine is a clinical practice that connects the patient to healthcare professionals through electronic platforms, potentially improving the self-management of patients and allowing the care of patients with limited access to health services. In these days when staying at home is recommended to minimize exposure and contamination risk, telerehabilitation can be considered as an advantage, using information and communication technologies to provide remote rehabilitation services to individuals at home. It has been reported that with telerehabilitation, improvements have been achieved in health outcomes and quality of life, such as reducing hospitalization rates and re-admissions, ensuring early discharge, facilitating access to rehabilitation services, decreasing costs, and ensuring early return to work. Regular physical activity and exercise provide many health benefits, such as increasing cardiorespiratory fitness and reducing symptoms of anxiety and depression. Increasing cardiorespiratory fitness may play a preventive and facilitating role against respiratory infections. This may prevent or help treat pneumonia and acute respiratory distress syndrome, which develops with COVID-19 and causes respiratory failure. It has been stated that there is a significant decrease in the level of physical activity globally in the period of social isolation, which is accepted worldwide during COVID-19 pandemic. Decrease in the level of physical activity and increase in sedentary behavior due to isolation limitations may cause rapid deterioration and premature death in cardiovascular health in a population with high cardiovascular risk. Considering that short-term (1-4 weeks) inactivity is associated with adverse effects on cardiovascular function and structure, and increased cardiovascular risk factors, it appears to be a clinically relevant intervention to promote the health benefits of home-based physical activity programs. In this study, a brochure created by physiotherapists for post-COVID-19 patients will be sent electronically. The number of repetitions and/or sets of the exercises in the brochure will be increased weekly by the physiotherapists according to the tolerance of the patients. Physical activity levels will be questioned at the beginning and at the end of each month to be maintained for three months in total. The need for isolation due to the COVID-19 pandemic creates an unprecedented, stressful situation for many people for an unknown period of time. In addition to increasing the level of anxiety and depression, this may have negative effects on sleep quality. Since sleep plays a main role in emotion regulation, sleep disturbances may have direct consequences on emotional functioning. Therefore, it was planned to evaluate depression and sleep in individuals who survived COVID-19 at the beginning and at the end of each month, for a total of three months. It will be possible to determine whether there is a relationship between depression and sleep efficiency with exercise recommendations that will be given in a controlled manner by a physiotherapist via telerehabilitation and increase according to the patient's tolerance. It has been reported that patients hospitalized with acute respiratory distress syndrome have post-traumatic stress disorder at a rate of 22% -24%, depression at a rate of 26% -33%, and general anxiety at a rate of 38% -44% even after 2 years. It has been reported that these are concerns that may accompany a serious decrease in quality of life and function after COVID-19. Therefore, it is planned to assess quality of life at the beginning and at the end of each month for a total of three months in individuals who survived COVID-19.

Post-discharge physical activity level, psychosocial status, sleep quality, quality of life, daily activities of living, and quality of life will be determined. The effect 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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 16, 2020

Anticipated Primary Completion Date :

Sep 16, 2022

Anticipated Study Completion Date :

Sep 16, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Physical activity level [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey

Sponsors and Collaborators

Hacettepe University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Aslihan Cakmak, Principal Investigator, Hacettepe University

ClinicalTrials.gov Identifier:

NCT04794374

Other Study ID Numbers:

KA-20085

First Posted:

Mar 12, 2021

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aslihan Cakmak, Principal Investigator, Hacettepe University

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 16, 2022