COVIDNCT04473898

Telerehabilitation After Coronavirus

A study testing Aerobic Exercise Training, Patient Education and Respiratory Exercise Training in people with COVID, run by KTO Karatay University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to investigate the effects of telerehabilitation program on COVID-19 symptoms, quality of life, level of depression, perception of dyspnea, sleep, fatigue, kinesiophobia and patient satisfaction in individuals diagnosed with COVID-19. Read more about this study

Who is it for?: Ages 25 to 70 years
Conditions the study is for: COVID
What is being tested?: Aerobic Exercise Training, Patient Education and Respiratory Exercise Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 19 Jun 2020to 17 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

volunteering to participate in the study
at least once diagnosed with COVID-19,
has a cognitive level that can adapt to online exercises,
having a physical condition suitable for exercises
staying in hospital due to covid-19

Who cannot join

refuse to participate in the study
having neurological, cardiac, respiratory disease that prevents exercise

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

KTO Karatay University
Konya, Karatay, 42030

Other trials in Turkey (Türkiye)

About this study

Official title: Telerehabilitation After Covid-19: Effectiveness of Respiratory and Aerobic Training

Read the detailed description

Because of the risk of infection, telerehabilitation applications are recommended for patients with COVID-19. There are no studies in the literature evaluating the effectiveness of telerehabilitation program after COVID-19. In particular, the importance of the first eight weeks after the disease was emphasized.

It is thought that the telerehabilitation program will improve the functional capacities and quality of life of patients in order to adapt to the daily life after the infection more easily, to cope with the symptoms brought about by the disease more easily and to prevent the respiratory distress, intensive care stay and inactivity due to muscle weakness.

Conditions: COVID
Being tested: Aerobic Exercise Training, Patient Education, Respiratory Exercise Training
Keywords: Covid-19, Telerehabilitation, Respiratory Exercises, Aerobic Exercises
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aerobic Exercise TrainingOther
Aerobic exercises using all body muscles and that one can do on their own after being shown online
Patient EducationBehavioural
Patient education about covid-19 and hygiene education
Respiratory Exercise TrainingOther
Respiratory exercises that one can do on their own after being shown online

Study groups in NCT04473898
Study group	Role	What they receive
Patient Education Group	Sham comparator	Information training about COViD-19 and its symptoms, hygiene education, family education Receives: Behavioral: Patient Education
Aerobic Training Group	Experimental	Teaching and regular follow-up of aerobic exercises shown online Receives: Other: Aerobic Exercise Training; Behavioral: Patient Education
Aerobic + Respiratory Training Group	Experimental	Teaching and regular follow-up of aerobic and respiratory exercises shown online Receives: Other: Aerobic Exercise Training; Behavioral: Patient Education; Other: Respiratory Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Dyspnoea
It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.
Measured: baseline
Anxiety and Depression
It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.
Measured: baseline
Sleep Quality
It will be evaluated by pittsburgh sleep quality index
Measured: baseline
Health Related Quality of Life
It will be evaluated by SF-36
Measured: baseline
Dyspnoea
It will be evaluated by the Modified Medical Research Council (mMRC). It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.
Measured: 6 weeks later
Anxiety and Depression
It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.
Measured: 6 weeks later
Sleep Quality
It will be evaluated by pittsburgh sleep quality index
Measured: 6 weeks later
Health Related Quality of Life
It will be evaluated by SF-36
Measured: 6 weeks later

Secondary outcomes (5)

Kinesiophobia
It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement
Measured: baseline
Patient Satisfaction
It will be evaluated by patient satisfaction scale. Likert scale questionnaire proposed seven dimensions of patient satisfaction directed toward their doctors. These are general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Increased score indicates decreased satisfaction. The minimum score is 18, the maximum score is 90.
Measured: 6 weeks later
Fatigue
It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.
Measured: baseline
Kinesiophobia
It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement
Measured: 6 weeks later
Fatigue
It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.
Measured: 6 weeks later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 202017 Feb 2021

First posted16 Jul 2020
Study start19 Jun 2020
Primary completion19 Oct 2020
Study completion17 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVIDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: It is planned to include 3 groups in the study. The group 1 will be informed about covid-19 and hygiene. Aerobic exercise will be offered to Group 2, aerobic exercise + breathing exercises will be offered to Group 3. The persons to be included in the groups will be determined randomly.
Masking: Single blind
Who is masked: Participant
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04473898
Sponsor's protocol ID: KaratayU2
Status last verified: Jul 2020
First submitted: 14 Jul 2020
Last updated: 18 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

All COVID trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telerehabilitation After Covid-19: Effectiveness of Respiratory and Aerobic Training
ClinicalTrials.gov ID: NCT04473898
Acronym / sponsor ID: KaratayU2
Conditions: COVID
Keywords: Covid-19, Telerehabilitation, Respiratory Exercises, Aerobic Exercises
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: KTO Karatay UniversityUniversity, hospital or other
Study start: 19 Jun 2020 (actual)
Primary completion: 19 Oct 2020 (actual)
Study completion: 17 Feb 2021 (actual)
First posted: 16 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: It is planned to include 3 groups in the study. The group 1 will be informed about covid-19 and hygiene. Aerobic exercise will be offered to Group 2, aerobic exercise + breathing exercises will be offered to Group 3. The persons to be included in the groups will be determined randomly.

Arm	Type	Receives
Patient Education Group	Sham comparator	Behavioral: Patient EducationInformation training about COViD-19 and its symptoms, hygiene education, family education
Aerobic Training Group	Experimental	Other: Aerobic Exercise Training, Behavioral: Patient EducationTeaching and regular follow-up of aerobic exercises shown online
Aerobic + Respiratory Training Group	Experimental	Other: Aerobic Exercise Training, Behavioral: Patient Education, Other: Respiratory Exercise TrainingTeaching and regular follow-up of aerobic and respiratory exercises shown online

Who may qualify

Ages: 25 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

volunteering to participate in the study
at least once diagnosed with COVID-19,
has a cognitive level that can adapt to online exercises,
having a physical condition suitable for exercises
staying in hospital due to covid-19

Key exclusion criteria (2 listed)

refuse to participate in the study
having neurological, cardiac, respiratory disease that prevents exercise

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aerobic Exercise TrainingAerobic exercises using all body muscles and that one can do on their own after being shown online	Other	Aerobic + Respiratory Training Group, Aerobic Training Group
Patient EducationPatient education about covid-19 and hygiene education	Behavioural	Aerobic + Respiratory Training Group, Aerobic Training Group, Patient Education Group
Respiratory Exercise TrainingRespiratory exercises that one can do on their own after being shown online	Other	Aerobic + Respiratory Training Group

Primary outcome

Dyspnoea
Time frame: baseline
It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.
Anxiety and Depression
Time frame: baseline
It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.
Sleep Quality
Time frame: baseline
It will be evaluated by pittsburgh sleep quality index
Health Related Quality of Life
Time frame: baseline
It will be evaluated by SF-36
Dyspnoea
Time frame: 6 weeks later
It will be evaluated by the Modified Medical Research Council (mMRC). It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.
Anxiety and Depression
Time frame: 6 weeks later
It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.
Sleep Quality
Time frame: 6 weeks later
It will be evaluated by pittsburgh sleep quality index
Health Related Quality of Life
Time frame: 6 weeks later
It will be evaluated by SF-36

5 secondary outcomes

Kinesiophobia
Time frame: baseline
Patient Satisfaction
Time frame: 6 weeks later
Fatigue
Time frame: baseline
Kinesiophobia
Time frame: 6 weeks later
Fatigue
Time frame: 6 weeks later

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Individual participant dataSharing planned: No

Related trials for COVID

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Özlem Akkoyun Sert, Phd, PT study director

KTO Karatay University

Kamil Yılmaz, Phd, PT study chair

KTO Karatay University

Osman Karaca, MsC,PT study chair

KTO Karatay University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise Training, Patient Education and Respiratory Exercise Training in people with COVID, run by KTO Karatay University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dyspnoea (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04473898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.