Effects of Telerehabilitation After Discharge in COVID-19 Survivors

January 12, 2023 updated by: Aslihan Cakmak, Hacettepe University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 6 months
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.
up to 6 months
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.
up to 6 months
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.
up to 6 months
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.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA-20085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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