COVID-19NCT05074979

Telerehabilitation in COVID-19 Survivors

A study testing telerehabilitation, home exercise program and informed program in people with COVID-19 and Telerehabilitation, run by Bandırma Onyedi Eylül 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

This study was carried out in the post-acute period of the telerehabilitation program in individuals with dyspnea who had COVID-19; It will be done to examine the effects on dyspnea, exercise capacity, respiratory functions, activities of daily living, muscle strength, muscle oxygenation, fatigue and quality of life… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: COVID-19, Telerehabilitation
What is being tested?: telerehabilitation, home exercise program and informed program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 27 Oct 2021to 30 Aug 2022
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with COVID-19 by Computed Tomography (CT) or PCR test between the ages of 18-75,
Do not have any orthopedic or neurological disease that will affect exercise capacity,
Individuals who can take and execute verbal orders,
Have had COVID-19 and at least 2 weeks have passed since the completion of the treatment,
Individuals who have a computer or smart phone with a camera and internet connection and have the ability to use it (the participant himself or one of his family members living in the same house),
Individuals who are sedentary (those whose physical activity level is inactive according to the Turkish version of the International Physical Activity Questionnaire (UFAA)),
Having dyspnea at level 2 or 3 on the Medical Research Council Dyspnea Scale.

Who cannot join

Those who have not had COVID-19 or acute period patients who are experiencing COVID-19,
Individuals who cannot be contacted,
Individuals with chronic heart disease,
Those with concomitant uncontrolled disease; uncontrolled hypertension (resting blood pressure ≥160 /100mmHg), uncontrolled diabetes (random instantaneous blood glucose>16.7 mmol/l, HbA1C>7.0%),
Those with concomitant severe organic disease (unstable hemodynamic heart disease, heart failure causing movement limitation, unstable angina, MI or other cardiac disease in the last 12 years),
Individuals with cerebrovascular disease in the last 6 months,

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Those with digestive system ulcer, thyroid dysfunction or active stage of tuberculosis,
Patients with Chronic Kidney Failure stage 3 and above according to Glomerular Filtration Rate (GFR),
Individuals who have undergone intraraticular medication or surgery from their lower extremities in the last 6 months,
Individuals who cannot walk independently,
Individuals with any mental illness that may prevent them from living independently or receiving treatment,
Uncooperative individuals for assessment and rehabilitation programs,
Those with alcohol or substance addiction,
Those who are pregnant, suspected of pregnancy or considering becoming pregnant,
Participants in another study within the last 3 months or currently.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Bandırma Onyedi Eylül University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Balıkesir, Bandırma, 10200

Other trials in Turkey (Türkiye)

About this study

Official title: Determining the Effectiveness of Telerehabilitation in COVID-19 Survivors

Conditions: COVID-19, Telerehabilitation
Being tested: telerehabilitation, home exercise program, informed program
Keywords: COVID-19, telerehabilitation, COVID-19 Survivors, functional capacity, pulmonary functions, peripheral muscle oxygenation, home workout program
Medical subject headings: COVID-19

What participants receive

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

telerehabilitationOther
While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
home exercise programOther
While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
informed programOther
will informed after COVID 19

Study groups in NCT05074979
Study group	Role	What they receive
control group	Other	While other groups continue their exercise program for 6 weeks, this group will only be informed after COVID 19. Receives: Other: informed program
home exercise program group	Experimental	this group will implement COVID 19 home exercise program. Receives: Other: home exercise program
telerehabilitation group	Experimental	this group will implement COVID 19 telerehabilitation program. Receives: Other: telerehabilitation

What is being measured

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

Severity of dyspnea assessment
Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
Measured: 6 weeks
Physical activity level assessment
The physical activity level of the participants will be evaluated with the Turkish version of the "International Physical Activity Questionnaire" (UFAA).In the last 7 days with the survey; Vigorous physical activity (football, basketball, aerobics, cycling fast, lifting weights, carrying loads, etc.) time (min), Intermediate physical activity (light weight carrying, cycling at normal speed, folk dances, dancing, bowling, table tennis etc.) duration (min), walking and sitting times for one day (min) are questioned. All participants were given pre-study to assess the condition of being sedentary and those with inactive physical activity levels will be included in the study.
Measured: 6 weeks
Cardiopulmonary endurance assessment
In order to evaluate cardiopulmonary endurance; A six-minute walking test will be applied. The test is 30 meters long, every 3 meters marked, the start and finish line are marked by a visible line, a smooth and straight done on the track. The distance the person walks for 6 minutes is recorded in meters.
Measured: 6 weeks
Evaluation of peripheral muscle oxygenation
"Moxy muscle oxygen monitor" will be used to measure regional oxygen saturation (SmO2) and total hemoglobin (Thb) amount in capillaries under the muscle. Moxy muscle oxygen monitor (Fortiori Design LLC, USA) near infrared It is placed on the skin in a non-invasive way with spectroscopy (NIRS), It is a device that regional blood flow and measures oxygenation. A moxy muscle oxygen monitor will be attached to the quadriceps femoris muscle of the participants with a velcro and oxygenation measurements will be taken during both the dinelnim and 6-minute walking test.
Measured: 6 weeks
Pulmonary function (slow vital capacity)
Single Breath Count Test will be used to evaluate slow vital capacity (the amount of air exhaled with slow exhalation after deep and maximal inspiration) and lung function. Single breath count (TNS), after maximal effort inhalation an individual with a metronome set to 2 beats per second in a normal speaking voice.
It is a measure of how much you can count in your cadence.
Measured: 6 weeks
Pulmonary function (Forced vital capacity (FVC))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
Measured: 6 weeks
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.
Measured: 6 weeks
Activities of daily living assessment
Barthel Index will be used to evaluate activities of daily living.
Measured: 6 weeks
Muscle strength assessment
Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.
Measured: 6 weeks
Perceived fatigue assessment
Participants' perceived fatigue level will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers.
consists of corresponding definitions It will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers consists of corresponding definitions. The Borg Scale is a subjective scale used to evaluate muscle fatigue.
Measured: 6 weeks
General fatigue assessment
Participants will be asked to answer the chalder fatigue scale, which includes 11 questions about their fatigue in the past month. The maximum total score is 33; 4 and above scorers are described as tired.
Measured: 6 weeks
Quality of life assessment
The Short Form-12 (SF-12) Questionnaire will be used to assess the quality of life.When scoring, two scores are obtained, the physical component and the mental component summary.
is done. High scores indicate good health.
Measured: 6 weeks
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Measured: 6 weeks
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
Measured: 6 weeks
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
Measured: 6 weeks
Pulmonary function (Peak flow rate (PEF)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.
Measured: 6 weeks

Timeline

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

27 Oct 202130 Aug 2022

First posted12 Oct 2021
Study start27 Oct 2021
Primary completion1 Aug 2022
Study completion30 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05074979
Sponsor's protocol ID: CDemir
Status last verified: Sep 2024
First submitted: 3 Oct 2021
Last updated: 19 Sep 2024
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

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determining the Effectiveness of Telerehabilitation in COVID-19 Survivors
ClinicalTrials.gov ID: NCT05074979
Acronym / sponsor ID: CDemir
Conditions: COVID-19, Telerehabilitation
Keywords: COVID-19, telerehabilitation, COVID-19 Survivors, functional capacity, pulmonary functions, peripheral muscle oxygenation, home workout program
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Bandırma Onyedi Eylül UniversityUniversity, hospital or other
Study start: 27 Oct 2021 (actual)
Primary completion: 1 Aug 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 12 Oct 2021 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
control group	Other	Other: informed programWhile other groups continue their exercise program for 6 weeks, this group will only be informed after COVID 19.
home exercise program group	Experimental	Other: home exercise programthis group will implement COVID 19 home exercise program.
telerehabilitation group	Experimental	Other: telerehabilitationthis group will implement COVID 19 telerehabilitation program.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosed with COVID-19 by Computed Tomography (CT) or PCR test between the ages of 18-75,
Do not have any orthopedic or neurological disease that will affect exercise capacity,
Individuals who can take and execute verbal orders,
Have had COVID-19 and at least 2 weeks have passed since the completion of the treatment,
Individuals who have a computer or smart phone with a camera and internet connection and have the ability to use it (the participant himself or one of his family members living in the same house),

Key exclusion criteria (15 listed)

Those who have not had COVID-19 or acute period patients who are experiencing COVID-19,
Individuals who cannot be contacted,
Individuals with chronic heart disease,
Those with concomitant uncontrolled disease; uncontrolled hypertension (resting blood pressure ≥160 /100mmHg), uncontrolled diabetes (random instantaneous blood glucose>16.7 mmol/l, HbA1C>7.0%),
Those with concomitant severe organic disease (unstable hemodynamic heart disease, heart failure causing movement limitation, unstable angina, MI or other cardiac disease in the last 12 years),

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
telerehabilitationWhile telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.	Other	telerehabilitation group
home exercise programWhile telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.	Other	home exercise program group
informed programwill informed after COVID 19	Other	control group

Primary outcome

Severity of dyspnea assessment
Time frame: 6 weeks
Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
Physical activity level assessment
Time frame: 6 weeks
The physical activity level of the participants will be evaluated with the Turkish version of the "International Physical Activity Questionnaire" (UFAA).In the last 7 days with the survey; Vigorous physical activity (football, basketball, aerobics, cycling fast, lifting weights, carrying loads, etc.) time (min), Intermediate physical activity (light weight carrying, cycling at normal speed, folk dances, dancing, bowling, table tennis etc.) duration (min), walking and sitting times for one day (min) are questioned. All participants were given pre-study to assess the condition of being sedentary and those with inactive physical activity levels will be included in the study.
Cardiopulmonary endurance assessment
Time frame: 6 weeks
In order to evaluate cardiopulmonary endurance; A six-minute walking test will be applied. The test is 30 meters long, every 3 meters marked, the start and finish line are marked by a visible line, a smooth and straight done on the track. The distance the person walks for 6 minutes is recorded in meters.
Evaluation of peripheral muscle oxygenation
Time frame: 6 weeks
"Moxy muscle oxygen monitor" will be used to measure regional oxygen saturation (SmO2) and total hemoglobin (Thb) amount in capillaries under the muscle. Moxy muscle oxygen monitor (Fortiori Design LLC, USA) near infrared It is placed on the skin in a non-invasive way with spectroscopy (NIRS), It is a device that regional blood flow and measures oxygenation. A moxy muscle oxygen monitor will be attached to the quadriceps femoris muscle of the participants with a velcro and oxygenation measurements will be taken during both the dinelnim and 6-minute walking test.
Pulmonary function (slow vital capacity)
Time frame: 6 weeks
Single Breath Count Test will be used to evaluate slow vital capacity (the amount of air exhaled with slow exhalation after deep and maximal inspiration) and lung function. Single breath count (TNS), after maximal effort inhalation an individual with a metronome set to 2 beats per second in a normal speaking voice. It is a measure of how much you can count in your cadence.
Pulmonary function (Forced vital capacity (FVC))
Time frame: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
Respiratory Muscle Strength
Time frame: 6 weeks
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.
Activities of daily living assessment
Time frame: 6 weeks
Barthel Index will be used to evaluate activities of daily living.
Muscle strength assessment
Time frame: 6 weeks
Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.
Perceived fatigue assessment
Time frame: 6 weeks
Participants' perceived fatigue level will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers. consists of corresponding definitions It will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers consists of corresponding definitions. The Borg Scale is a subjective scale used to evaluate muscle fatigue.
General fatigue assessment
Time frame: 6 weeks
Participants will be asked to answer the chalder fatigue scale, which includes 11 questions about their fatigue in the past month. The maximum total score is 33; 4 and above scorers are described as tired.
Quality of life assessment
Time frame: 6 weeks
The Short Form-12 (SF-12) Questionnaire will be used to assess the quality of life.When scoring, two scores are obtained, the physical component and the mental component summary. is done. High scores indicate good health.
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time frame: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Pulmonary function (FEV1 / FVC)
Time frame: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Time frame: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
Pulmonary function (Peak flow rate (PEF)
Time frame: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.

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 19 Sep 2024.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 15 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 19 Sep 2024. 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. 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?

Severity of dyspnea assessment (time frame: 6 weeks). The study lists 16 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 NCT05074979.

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 19 Sep 2024.