HypoxiaNCT05709262
Comparison of Different Walk and Performance Test in Detecting Silent Hypoxia
An observational study of Hypoxia and COVID-19 Pneumonia, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Healthcare systems around the world have been dealing with COVID 19. One of the main manifestations of this infection is lung involvement of varying degrees, causing a spectrum of diseases from mild lower respiratory tract infection to severe Adult Respiratory Distress Syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoxia, COVID-19 Pneumonia, Oxygen Saturation
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2021to 6 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will consist of Covid-19 patients hospitalized in the pandemic wards of Kütahya Health Sciences University Physical Medicine and Rehabilitation Additional Service building. All volunteer patients who meet our inclusion and exclusion criteria will undergo walking field tests with at least 2 hours between them after their written consent is obtained.
Who may be able to join
- Patients with a diagnosis of covid 19 between the ages of 18-80
- Patients with a SaO2 value > 93 in room air
- Patients who do not have dyspnea symptoms in room air during rest
- Patients whose breathing frequence < 21 at rest
- Patients who can walk independently and get up from their seat
- Patients who did not receive any rehabilitation
- Patients who can cooperate and who are fully oriented
- Patients who volunteered to participate in the study
Who cannot join
- Severe pnemonia due to Covid-19
- Exacerbation, severe respiratory failure (resting partial pressure of oxygen in standard ambient conditions of less than 55 mmHg), and inability or unwillingness to understand or comply with the study protocol.
- Unable to walk unaided
- Patients diagnosed with vertigo, Meniere, etc. balance disorder and dizziness
- Patients diagnosed with orthostatic hypotension
- Patients diagnosed with neurologic disease such as: stroke, ms-like neuromotor pathology
Show all 9Show fewer
- pregnant women and those diagnosed with epilepsy
- Patients with BMI > 35
- Patients with problems in cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department
Kütahya
About this study
Official title: Comparison of Different Walk and Performance Test in Detecting Silent Hypoxia in SARS-CoV-2
Healthcare systems around the world have been dealing with COVID 19. One of the main manifestations of this infection is lung involvement of varying degrees, causing a spectrum of diseases from mild lower respiratory tract infection to severe Adult Respiratory Distress Syndrome (ARDS). One of the important clinical parameters is to detect hypoxia early in order to initiate a higher level of care at the earliest. The presence of silent or latent hypoxia has made this task difficult in COVID 19. Besides, critical findings such as silent hypoxia that is not at rest but triggered by effort can be revealed by some practical field tests such as the 6-minute walk test or the 1-minute chair sit and stand test. Moreover, these simple tools also help to investigate the patient's readiness for discharge. In this way, it will be useful to evaluate their usability in discharge decisions or in determining the post-discharge cardiopulmonary reserves of the patients and therefore their rehabilitation needs. Although walk and performance tests can be performed naturally, safely and simply, more similarly to movements in daily living activities compared to cardiopulmonary exercise tests, the interest in these tests has increased over the years, especially in subjects such as exercise capacity, mortality and morbidity expectation, or oxygen desaturation in patients with chronic cardiopulmonary pathology. The number of studies in 19 patients is quite limited. For this reason, the necessity of new studies on different field tests to detect the presence of latent hypoxia, which expresses the oxygen desaturation triggered by effort, and to evaluate the exercise tolerance status before discharge, has been emphasized in recent reviews.The aim of this study is to determine the presence of silent hypoxia, which expresses the oxygen desaturation triggered by effort, in Covid-19 patients and to compare the different short-term walk and performance tests, which the investigators consider easier and applicable in the conditions of the pandemic environment, with the classical gold standard test ( Six minute walk test) in order to evaluate the exercise tolerance status of the patients before discharge.
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test
The six-minute walk test is a submaximal exercise test that can be safely performed even by patients with heart failure who cannot tolerate the maximal exercise test. The test is very simple, requires inexpensive equipment, and is reproducible. In addition, it is considered safe as patients are self-limiting during exercise. The 6-minute walk test, which is performed in diseases such as pulmonary hypertension and COPD, is simply used to show the shortness of breath on exertion and the exercise capacity of the patient. In the 6-minute walking test, the patient is preferably walked along a straight corridor of at least 30 meters as fast as he can, but without running. Measure how many meters patients walk.
Measured: 10 minutes
Two minute walk test
The Two Minute Walk Test is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test.
Measured: Baseline
Fourty step walk test
Patients are asked to take 40 steps and time is kept. At the same time, oxygen desaturations are checked. This test, which is widely used in the triage and discharge evaluation of Covid-19 patients, especially in the UK, and aims to detect exertional desaturation, has not been validated in any disease yet, but it can be applied even at home in current reviews because it requires less effort and is found to be quite safe compared to other tests. highlighted as a test. On the other hand, the sensitivity was expressed as low because it was not a compelling test.
Measured: Baseline
30 Second Sit to Stand Test
The 30 Second Sit to Stand Test is also known as 30 second chair stand test, is for testing endurance. It is part of the Fullerton Functional Fitness Test Battery. To determine the oxygen saturation, the patient is observed with the pulse saturation probe for 1 minute after the test.
Measured: Baseline
1 Minute Sit to Stand Test
The 1-min sit-to-stand test evaluate in mild COVID-19 cases (not requiring intensive care unit admission on initial evaluation if their SpO2 was more than 95% while breathing ambient air.
Measured: Baseline
Secondary outcomes (1)
Vital measurements before, during and after walk test
Patients will wear a mobile pulse oximeter that continuously recorded heart rate and oxygen saturation. The device will used to record breathing frequency via a nasal cannula. Baseline values of oxygen saturation, heart rate, breathing frequency, and ratings of perceived exertion on the modified Borg scale (0-10) for dyspnea and leg fatigue will be recorded before, during and immediate after walk tests.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start19 Dec 2021
- Primary completion19 Apr 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
- Investigators
- Ismail Saracoglu, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709262
- Sponsor's protocol ID
- KSBUSilentHypoxi
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 2 Feb 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 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Walk and Performance Test in Detecting Silent Hypoxia in SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05709262
- Acronym / sponsor ID
- KSBUSilentHypoxi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 2 Feb 2023 (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.
Healthcare systems around the world have been dealing with COVID 19. One of the main manifestations of this infection is lung involvement of varying degrees, causing a spectrum of diseases from mild lower respiratory tract infection to severe Adult Respiratory Distress Syndrome (ARDS). One of the important clinical parameters is to detect hypoxia early in order to initiate a higher level of care at the earliest. The presence of silent or latent hypoxia has made this task difficult in COVID 19. Besides, critical findings such as silent hypoxia that is not at rest but triggered by effort can be revealed by some practical field tests such as the 6-minute walk test or the 1-minute chair sit and stand test. Moreover, these simple tools also help to investigate the patient's readiness for discharge. In this way, it will be useful to evaluate their usability in discharge decisions or in determining the post-discharge cardiopulmonary reserves of the patients and therefore their rehabilitation needs. Although walk and performance tests can be performed naturally, safely and simply, more similarly to movements in daily living activities compared to cardiopulmonary exercise tests, the interest in these tests has increased over the years, especially in subjects such as exercise capacity, mortality and morbidity expectation, or oxygen desaturation in patients with chronic cardiopulmonary pathology. The number of studies in 19 patients is quite limited. For this reason, the necessity of new studies on different field tests to detect the presence of latent hypoxia, which expresses the oxygen desaturation triggered by effort, and to evaluate the exercise tolerance status before discharge, has been emphasized in recent reviews.The aim of this study is to determine the presence of silent hypoxia, which expresses the oxygen desaturation triggered by effort, in Covid-19 patients and to compare the different short-term walk and performance tests, which the investigators consider easier and applicable in the conditions of the pandemic environment, with the classical gold standard test ( Six minute walk test) in order to evaluate the exercise tolerance status of the patients before discharge.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will consist of Covid-19 patients hospitalized in the pandemic wards of Kütahya Health Sciences University Physical Medicine and Rehabilitation Additional Service building. All volunteer patients who meet our inclusion and exclusion criteria will undergo walking field tests with at least 2 hours between them after their written consent is obtained.
Key inclusion criteria (8 listed)
- Patients with a diagnosis of covid 19 between the ages of 18-80
- Patients with a SaO2 value > 93 in room air
- Patients who do not have dyspnea symptoms in room air during rest
- Patients whose breathing frequence < 21 at rest
- Patients who can walk independently and get up from their seat
Key exclusion criteria (9 listed)
- Severe pnemonia due to Covid-19
- Exacerbation, severe respiratory failure (resting partial pressure of oxygen in standard ambient conditions of less than 55 mmHg), and inability or unwillingness to understand or comply with the study protocol.
- Unable to walk unaided
- Patients diagnosed with vertigo, Meniere, etc. balance disorder and dizziness
- Patients diagnosed with orthostatic hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Six minute walk test
Time frame: 10 minutes
The six-minute walk test is a submaximal exercise test that can be safely performed even by patients with heart failure who cannot tolerate the maximal exercise test. The test is very simple, requires inexpensive equipment, and is reproducible. In addition, it is considered safe as patients are self-limiting during exercise. The 6-minute walk test, which is performed in diseases such as pulmonary hypertension and COPD, is simply used to show the shortness of breath on exertion and the exercise capacity of the patient. In the 6-minute walking test, the patient is preferably walked along a straight corridor of at least 30 meters as fast as he can, but without running. Measure how many meters patients walk.
Two minute walk test
Time frame: Baseline
The Two Minute Walk Test is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test.
Fourty step walk test
Time frame: Baseline
Patients are asked to take 40 steps and time is kept. At the same time, oxygen desaturations are checked. This test, which is widely used in the triage and discharge evaluation of Covid-19 patients, especially in the UK, and aims to detect exertional desaturation, has not been validated in any disease yet, but it can be applied even at home in current reviews because it requires less effort and is found to be quite safe compared to other tests. highlighted as a test. On the other hand, the sensitivity was expressed as low because it was not a compelling test.
30 Second Sit to Stand Test
Time frame: Baseline
The 30 Second Sit to Stand Test is also known as 30 second chair stand test, is for testing endurance. It is part of the Fullerton Functional Fitness Test Battery. To determine the oxygen saturation, the patient is observed with the pulse saturation probe for 1 minute after the test.
1 Minute Sit to Stand Test
Time frame: Baseline
The 1-min sit-to-stand test evaluate in mild COVID-19 cases (not requiring intensive care unit admission on initial evaluation if their SpO2 was more than 95% while breathing ambient air.
1 secondary outcome
Vital measurements before, during and after walk test
Time frame: Baseline
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 2 Feb 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.
Ismail Saracoglu principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and COVID-19 Pneumonia, run by Kutahya Health Sciences 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 8 inclusion and 9 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 2 Feb 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?
Six minute walk test (time frame: 10 minutes). The study lists 5 primary outcomes in all. 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 2 Feb 2023.