Tele-Rehabilitation in Individuals With Covid-19

January 18, 2023 updated by: Emine Nur Demircan, Hacettepe University

Investigation of the Effect of Telerehabilitation-Based Physiotherapy Training on Respiration, Quality of Life, Physical Activity and Fatigue in Individuals With Covid-19

Coronavirus Disease (COVID-19) is a respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2). This study was planned as a single-blind randomized controlled pilot study to compare the effectiveness of telerehabilitation-based exercise training applied to individuals with Covid-19. Individuals will be divided into two groups, the control group and the study group. All assessments will be made online twice, before and after treatment. Socio-demographic data of individuals who agreed to participate in the study, disease information about Covid-19, MRC Dyspnea Scale, COVID-19 Fear Scale, International Physical Activity Questionnaire-Short Form, ST. George Respiratory Questionnaire, Fatigue Severity Scale, Nottingham Health Profile will be questioned and recorded. The obtained data will be analyzed with statistical methods.

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.

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.
50

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A score in the range of 0-3 on the MRC Dyspnea Scale.
  • Not have any vestibular, orthopedic or neurological disease that will affect muscle strength, balance and coordination.
  • Not having undergone surgery in the last 6 months.
  • Not having undergone any surgical procedure that may affect the musculoskeletal system of the spinal column, lower extremities or upper extremities.
  • It was being cooperative and volunteering.

Exclusion Criteria:

  • Severe liver and kidney disease or new and progressive damage to liver and kidney function, deep vein thrombosis and pulmonary embolism, suspected aortic stenosis, having a disease/condition for which exercise is contraindicated.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Experimental Group
Other: Exercise
Home-based physical activity programs are very important to strengthen the immune system, which is extremely important in the fight against COVID-19 infection, and to protect physical and mental health. In addition, since the pulmonary rehabilitation sessions carry a high risk of transmission, it is recommended that the program be carried out with applications such as single-session training, tele-rehabilitation or home program. Although the home pulmonary rehabilitation program is adapted to the individual, it generally includes positioning, mobilization, relaxation exercises, respiratory training, respiratory muscle exercises, upper and lower extremity exercises, walking, climbing stairs and cycling exercises. The general opinion is that telerehabilitation practices have many benefits such as increasing the quality of life and physical activity. In addition to these benefits, telerehabilitation applications come to the fore in the Covid-19 period with its complementary feature.
Experimental: Control Group
Other: Exercise
Home-based physical activity programs are very important to strengthen the immune system, which is extremely important in the fight against COVID-19 infection, and to protect physical and mental health. In addition, since the pulmonary rehabilitation sessions carry a high risk of transmission, it is recommended that the program be carried out with applications such as single-session training, tele-rehabilitation or home program. Although the home pulmonary rehabilitation program is adapted to the individual, it generally includes positioning, mobilization, relaxation exercises, respiratory training, respiratory muscle exercises, upper and lower extremity exercises, walking, climbing stairs and cycling exercises. The general opinion is that telerehabilitation practices have many benefits such as increasing the quality of life and physical activity. In addition to these benefits, telerehabilitation applications come to the fore in the Covid-19 period with its complementary feature.

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
The Fear of COVID-19 Scale
Time Frame: baseline to 6 week after
The Fear of COVID-19 Scale was used to measure the level of fear caused by Covid-19. Each question of the scale, which consists of 7 questions, is graded on a 5-point Likert scale (1- I strongly disagree. 5- I strongly agree). A high score indicates greater fear of Covid-19.
baseline to 6 week after
MRC Dyspnea Scale
Time Frame: baseline
The MRC Dyspnea Scale was used to assess the participants' dyspnea levels. It is a five-point scale based on various physical exercises that produce a feeling of dyspnea. It consists of five items. The person's respiratory distress is graded from 0 (no shortness of breath) to 4 (shortness of breath during activities such as being confined to home and dressing).
baseline
International Physical Activity Questionnaire-Short Form
Time Frame: baseline to 6 week after
The physical activity levels of the participants were evaluated with the International Physical Activity Questionnaire-Short Form. The questionnaire assessing the level of physical activity over the past 7 days provides information about walking, moderate activities, and time spent sitting. Individuals' physical activity levels are divided into three categories according to the scores obtained: "inactive", "minimally active" and "very active".
baseline to 6 week after
St. George's Respiratory Questionnaire, SGRQ
Time Frame: baseline to 6 week after
The quality of life of individuals, a test that measures health-related quality of life for respiratory diseases, ST. George Respiratory Questionnaire. st. George Respiratory Questionnaire; It has three sub-branches as symptoms (8 items), activities (16 items), and effects of the disease (26 items) and consists of a total of 50 items. The total score of the test is between 0-100 (0 score is normal, 100 indicates maximum disability.)
baseline to 6 week after
Fatigue Severity Scale
Time Frame: baseline to 6 week after
The Fatigue Severity Scale, which measures the severity of fatigue in the last month, was used to determine the severity of fatigue. The scale consists of nine questions and each question is graded over seven points. The total score ranges from 9 to 63 points. High scores indicate fatigue, 28 points and above indicate the presence of severe fatigue.
baseline to 6 week after
Nottingham Health Profile
Time Frame: baseline to 6 week after
The Nottingham Health Profile was also used to assess the participants' health-related quality of life. NSP is a general quality of life questionnaire that measures the individual's perceived health problems and the level of these problems that affect normal daily activities. The first part of the NSP, which was developed in two parts, consists of 38 items and evaluates six parameters related to health level.
baseline to 6 week after

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.
  • Principal Investigator: Emine Nur Demircan, PT, MSc, 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.
April 15, 2022

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.
September 15, 2022

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.
October 15, 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 30, 2022

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 30, 2022

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 31, 2022

Study Record Updates

Last Update Posted (Estimate)

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 19, 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 18, 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.
  • COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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