COVID-19NCT05205434
Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges
A study testing Synchronous telerehabilitation programme and Asynchronous telerehabilitation programme in people with COVID-19 and Telerehabilitation, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19. 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?
- Synchronous telerehabilitation programme and Asynchronous telerehabilitation programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2021to 7 Sep 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
- COVID-19 patients in the subacute period discharged
- Be 18 years or older
- Having received oxygen therapy or mechanical ventilation support in the hospital
- Access to online interviews and web-based exercises with a secure internet connection
- Having sufficient speaking and hearing skills for telerehabilitation
- Volunteer to participate in research
Who cannot join
- Unstable clinical condition
- Having had cerebrovascular disease, intra-articular drug injection or surgery of the lower extremities in the last 6 months
- Inability to walk independently, even with an assistive device
- Having serious neuromuscular problems
- Not being cooperative enough to answer and understand questionnaires and scales
Trial locations and contacts
1 site in 1 country.
About this study
Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19.
Read the detailed description
Fifty seven participants will be enrolled. Participants will be randomly divided into 3 groups.
For this purpose, patients will be recruited at the time of discharge from the hospital and two experimental groups with the same physical therapy and educational program will be carried out. participants in the control group will only educational program. Participants in experimental groups will be followed using videoconference interviews from synchronous telerehabilitation methods and mobile application from asynchronous telerehabilitation methods at home. These participants will be given an 8-week exercise program. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and the patients will be evaluated before and after the treatment.
After treatment programs, the functional capacity, performance, and hemodynamic parameters of the participants will be evaluated. Quality of life, physical activity level, anxiety-depression, and fatigue severity will also be evaluated with questionnaires.
- Conditions
- COVID-19, Telerehabilitation
- Being tested
- Synchronous telerehabilitation programme, Asynchronous telerehabilitation programme
- Keywords
- COVID-19, Telerehabilitation, Exercise program, Breathing 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.
Synchronous telerehabilitation programmeOther
Also called Video conference
Exercise program and educational program
Asynchronous telerehabilitation programmeOther
Also called Mobil application
Exercise program educational program
| Study group | Role | What they receive |
|---|---|---|
| Synchronous telerehabilitation program (Video conference) | Experimental | Participants will exercise program at home for an average of 30 minutes a day, 3 days a week, under the supervision of a physiotherapist via synchronized video conference. The program will continue for 8 weeks. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and an educational program. Physical exercises will be adjusted in 3 different difficulty levels: sitting, standing with or without support. Receives: Other: Synchronous telerehabilitation programme |
| Asynchronous telerehabilitation programme (Mobil app.) | Experimental | The same exercises as in the synchronous telerehabilitation program will be done at the same frequency. Participants will watch the videos sent by the investigator via the mobile application and then do the exercises at home. The participants will meet with the investigator once a week to an update exercise program. Receives: Other: Asynchronous telerehabilitation programme |
| Control | No intervention | Participants in this group will only receive an educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Shuttle Walk Test (ISWT)
The participant will be asked to walk around two 9-meter cones and complete them within the given time. Oxygen saturation and heart rate will be measured before and immediately after the test. They will be asked to self-report dyspnea and fatigue according to the modified Borg scale (0-10).
Measured: Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months
Secondary outcomes (2)
30-Second Chair Stand Test (30 CST)
The patient will be asked to sit and stand as much as possible within 30 seconds, with his hands crossed over his chest. The number of sitting and staying for 30 seconds will be noted.
Measured: Change from baseline number of sitting and staying of the patients at the end of the 8th week and, postintervation sixth months
Brief Physical Performance Battery (BPPB)
It is a test used to evaluate the lower extremity function of patients. This battery represents the sum of 3 functional tests such as standing stance tests, 4 meters walking test and 5 times chair sit and stand (5STS). Each test is scored between 0 (not completing the test) and 4 (highest performance level)
Measured: Change from baseline score of the patients at the end of the 8th week and, postintervation sixth months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start25 Sep 2021
- Primary completion5 Aug 2022
- Study completion7 Sep 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Abdurrahman Tanhan, Bitlis Eren University
- Investigators
- Abdurrahman TANHAN, MSc, Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205434
- Sponsor's protocol ID
- BitlisErenU2
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges
- ClinicalTrials.gov ID
- NCT05205434
- Acronym / sponsor ID
- BitlisErenU2
- Conditions
- COVID-19, Telerehabilitation
- Keywords
- COVID-19, Telerehabilitation, Exercise program, Breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 25 Jan 2022 (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.
Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19.
Detailed description
Fifty seven participants will be enrolled. Participants will be randomly divided into 3 groups.
For this purpose, patients will be recruited at the time of discharge from the hospital and two experimental groups with the same physical therapy and educational program will be carried out. participants in the control group will only educational program. Participants in experimental groups will be followed using videoconference interviews from synchronous telerehabilitation methods and mobile application from asynchronous telerehabilitation methods at home. These participants will be given an 8-week exercise program. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and the patients will be evaluated before and after the treatment.
After treatment programs, the functional capacity, performance, and hemodynamic parameters of the participants will be evaluated. Quality of life, physical activity level, anxiety-depression, and fatigue severity will also be evaluated with questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Synchronous telerehabilitation program (Video conference) | Experimental | Other: Synchronous telerehabilitation programmeParticipants will exercise program at home for an average of 30 minutes a day, 3 days a week, under the supervision of a physiotherapist via synchronized video conference. The program will continue for 8 weeks. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and an educational program. Physical exercises will be adjusted in 3 different difficulty levels: sitting, standing with or without support. |
| Asynchronous telerehabilitation programme (Mobil app.) | Experimental | Other: Asynchronous telerehabilitation programmeThe same exercises as in the synchronous telerehabilitation program will be done at the same frequency. Participants will watch the videos sent by the investigator via the mobile application and then do the exercises at home. The participants will meet with the investigator once a week to an update exercise program. |
| Control | No intervention | –Participants in this group will only receive an educational program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- COVID-19 patients in the subacute period discharged
- Be 18 years or older
- Having received oxygen therapy or mechanical ventilation support in the hospital
- Access to online interviews and web-based exercises with a secure internet connection
- Having sufficient speaking and hearing skills for telerehabilitation
Key exclusion criteria (5 listed)
- Unstable clinical condition
- Having had cerebrovascular disease, intra-articular drug injection or surgery of the lower extremities in the last 6 months
- Inability to walk independently, even with an assistive device
- Having serious neuromuscular problems
- Not being cooperative enough to answer and understand questionnaires and scales
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 |
|---|---|---|
| Synchronous telerehabilitation programmeAlso: Video conferenceExercise program and educational program | Other | Synchronous telerehabilitation program (Video conference) |
| Asynchronous telerehabilitation programmeAlso: Mobil applicationExercise program educational program | Other | Asynchronous telerehabilitation programme (Mobil app.) |
Primary outcome
Incremental Shuttle Walk Test (ISWT)
Time frame: Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months
The participant will be asked to walk around two 9-meter cones and complete them within the given time. Oxygen saturation and heart rate will be measured before and immediately after the test. They will be asked to self-report dyspnea and fatigue according to the modified Borg scale (0-10).
2 secondary outcomes
30-Second Chair Stand Test (30 CST)
Time frame: Change from baseline number of sitting and staying of the patients at the end of the 8th week and, postintervation sixth months
Brief Physical Performance Battery (BPPB)
Time frame: Change from baseline score of the patients at the end of the 8th week and, postintervation sixth months
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 9 Mar 2023.
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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.
Abdurrahman TANHAN, MSc principal investigator
Bitlis Eren 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 Synchronous telerehabilitation programme and Asynchronous telerehabilitation programme in people with COVID-19 and Telerehabilitation, run by Bitlis Eren 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 6 inclusion and 5 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 9 Mar 2023. 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?
Incremental Shuttle Walk Test (ISWT) (time frame: Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2023.