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Effects of Telerehabilitation After Discharge in COVID-19 Survivors

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring telerehabilitation, physical activity, sleep quality, post COVID-19, quality of life

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Discharged COVID-19 survivors

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2021
Last Updated
January 12, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04794374
Brief Title
Effects of Telerehabilitation After Discharge in COVID-19 Survivors
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
October 27, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
telerehabilitation, physical activity, sleep quality, post COVID-19, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Discharged COVID-19 survivors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
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 Measure Information:
Title
Physical activity level
Description
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.
Time Frame
up to 6 months
Title
Psychosocial status
Description
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.
Time Frame
up to 6 months
Title
Sleep quality
Description
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.
Time Frame
up to 6 months
Title
Health related quality of life
Description
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.
Time Frame
up to 6 months
Title
Activities of daily living
Description
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.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lale Ozisik, Assoc.Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nursel Calik Basaran, Asst.Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oguz Abdullah Uyaroglu, Asst.Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deniz Inal-Ince, Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Naciye Vardar-Yagli, Assoc.Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Melda Saglam, Assoc.Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ebru Calik-Kutukcu, Assoc.Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esra Kinaci, MSc, PT.
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gulay Sain Guven, Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aslihan Cakmak, MSc, PT.
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Telerehabilitation After Discharge in COVID-19 Survivors

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