COVID-19NCT05957575
Investigation of the Muscle Oxygenation in Patients With Post COVID-19 Syndrome
An observational study of COVID-19, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
More than 60% of patients infected with COVID-19 have long-term symptoms. These symptoms are associated with common ground-glass opacities on computed tomography scans and chest radiographs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2022to 20 Jul 2023
- How long will I take part?
- 2 Days
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thirty eight patients with pulmonary involvement post-COVID syndrome were recruited for the study. Pulmonary involvement of the patients was determined by a pulmonologist according to the results of computed tomography.Patients referred from Gazi University, Faculty of Medicine, Department of Chest Diseases for pulmonary rehabilitation to Cardiopulmonary Rehabilitation Unit located in the Faculty of Health Sciences were recruited, Department of Physiotherapy and Rehabilitation.
Who may be able to join
- Between the ages of 18-75
- Diagnosed with pulmonary involvement COVID-19
- Volunteer to participate in the study
Who cannot join
- Body mass index >35 kg/m2
- Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
- Aortic stenosis, complex arrhythmia, aortic aneurysm
- Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
- Cognitive impairment that causes difficulty in understanding and following exercise test instructions
- Participated in a planned exercise program in the last three months
- Uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
- Contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Ankara, 06560
About this study
Official title: Comparison of the Muscle Oxygenation During Submaximal and Maximal Exercise Tests in Patients With Post COVID-19 Syndrome
More than 60% of patients infected with COVID-19 have long-term symptoms. These symptoms are associated with common ground-glass opacities on computed tomography scans and chest radiographs. The pathophysiology of long-term persistent symptoms is largely unknown, but hypoxia and hypoxic tissue damage, decreased pulmonary diffusion capacity, ventilation-perfusion mismatch, and lung fibrosis caused by COVID-19-associated pneumonia are thought to cause long-term symptoms. Desaturation may occur during exercise due to hypoxia, pneumonia and lung involvement in patients with post-COVID syndrome. Oxygenation of peripheral muscles may decrease due to hypoxemia, but there is not enough study on this subject yet.
Read the detailed description
Post-COVID syndrome is defined as unexplained signs or symptoms that develop during or after infection with COVID-19 and persist for 12 weeks. Long-term symptoms include fatigue, dyspnea, impaired exercise and lung function.It is important to understand physiological mechanisms underlying persistent dyspnea, fatigue, and impaired exercise capacity after COVID-19 infection to develop appropriate rehabilitation interventions while improving these symptoms. The pathophysiology of long-term persistent symptoms is largely unknown, however hypoxia and hypoxic tissue damage caused by COVID-19-associated pneumonia, decreased pulmonary diffusion capacity, ventilation-perfusion mismatch and lung fibrosis have been hypothesized. The effect of hypoxemia associated with COVID-19 on oxygenation of peripheral muscles and muscle oxygenation at submaximal and maximal exercise intensity has not been investigated, yet.
The aim of our study is to evaluate and compare quadriceps femoris muscle oxygenation in submaximal and maximal exercise tests in patients with post-COVID syndrome.
Patients referred from Gazi University, Faculty of Medicine, Department of Chest Diseases for pulmonary rehabilitation to Cardiopulmonary Rehabilitation Unit located in the Faculty of Health Sciences were recruited, Department of Physiotherapy and Rehabilitation, between March 2022 and May 2023. Muscle oxygenation during six-minute walk test and cardiopulmonary exercise test on two different days was measured and compared.
- Conditions
- COVID-19
- Keywords
- COVID-19, oxygen consumption
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of muscle oxygenation (SmO2)
The saturation of oxygen in muscles (SmO2) was evaluated using a non-invasive method Moxy® device (Moxy®, Fortiori Design LLC, Minnesota, USA).
Measured: through study completion, an average of 18 months
Secondary outcomes (4)
Maximal exercise capacity
Cardiopulmonary Exercise Test
Measured: through study completion, an average of 18 months
Submaximal exercise capacity
Six minute walk test
Measured: through study completion, an average of 18 months
Peripheral Muscle Strength
Hand held dynamometer
Measured: through study completion, an average of 18 months
Functional Status
Post-COVID-19 Functional Status scale (PCFS)
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start25 Feb 2022
- Primary completion15 Jun 2023
- Study completion20 Jul 2023
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.
- More trials run by Gazi 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Başak KAVALCI KOL, Pt. MSc., Principal investigator, Gazi UniversityEce BAYTOK, Pt. MSc., Principal investigator, Gazi UniversityNilgün YILMAZ DEMİRCİ, Assoc. Prof., Principal investigator, Gazi UniversityMeral BOŞNAK GÜÇLÜ, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957575
- Sponsor's protocol ID
- Gazi University 5
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Muscle Oxygenation During Submaximal and Maximal Exercise Tests in Patients With Post COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT05957575
- Acronym / sponsor ID
- Gazi University 5
- Conditions
- COVID-19
- Keywords
- COVID-19, oxygen consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 24 Jul 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.
More than 60% of patients infected with COVID-19 have long-term symptoms. These symptoms are associated with common ground-glass opacities on computed tomography scans and chest radiographs. The pathophysiology of long-term persistent symptoms is largely unknown, but hypoxia and hypoxic tissue damage, decreased pulmonary diffusion capacity, ventilation-perfusion mismatch, and lung fibrosis caused by COVID-19-associated pneumonia are thought to cause long-term symptoms. Desaturation may occur during exercise due to hypoxia, pneumonia and lung involvement in patients with post-COVID syndrome. Oxygenation of peripheral muscles may decrease due to hypoxemia, but there is not enough study on this subject yet.
Detailed description
Post-COVID syndrome is defined as unexplained signs or symptoms that develop during or after infection with COVID-19 and persist for 12 weeks. Long-term symptoms include fatigue, dyspnea, impaired exercise and lung function.It is important to understand physiological mechanisms underlying persistent dyspnea, fatigue, and impaired exercise capacity after COVID-19 infection to develop appropriate rehabilitation interventions while improving these symptoms. The pathophysiology of long-term persistent symptoms is largely unknown, however hypoxia and hypoxic tissue damage caused by COVID-19-associated pneumonia, decreased pulmonary diffusion capacity, ventilation-perfusion mismatch and lung fibrosis have been hypothesized. The effect of hypoxemia associated with COVID-19 on oxygenation of peripheral muscles and muscle oxygenation at submaximal and maximal exercise intensity has not been investigated, yet.
The aim of our study is to evaluate and compare quadriceps femoris muscle oxygenation in submaximal and maximal exercise tests in patients with post-COVID syndrome.
Patients referred from Gazi University, Faculty of Medicine, Department of Chest Diseases for pulmonary rehabilitation to Cardiopulmonary Rehabilitation Unit located in the Faculty of Health Sciences were recruited, Department of Physiotherapy and Rehabilitation, between March 2022 and May 2023. Muscle oxygenation during six-minute walk test and cardiopulmonary exercise test on two different days was measured and compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty eight patients with pulmonary involvement post-COVID syndrome were recruited for the study. Pulmonary involvement of the patients was determined by a pulmonologist according to the results of computed tomography.Patients referred from Gazi University, Faculty of Medicine, Department of Chest Diseases for pulmonary rehabilitation to Cardiopulmonary Rehabilitation Unit located in the Faculty of Health Sciences were recruited, Department of Physiotherapy and Rehabilitation.
Key inclusion criteria (3 listed)
- Between the ages of 18-75
- Diagnosed with pulmonary involvement COVID-19
- Volunteer to participate in the study
Key exclusion criteria (8 listed)
- Body mass index >35 kg/m2
- Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
- Aortic stenosis, complex arrhythmia, aortic aneurysm
- Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
- Cognitive impairment that causes difficulty in understanding and following exercise test instructions
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
Measurement of muscle oxygenation (SmO2)
Time frame: through study completion, an average of 18 months
The saturation of oxygen in muscles (SmO2) was evaluated using a non-invasive method Moxy® device (Moxy®, Fortiori Design LLC, Minnesota, USA).
4 secondary outcomes
Maximal exercise capacity
Time frame: through study completion, an average of 18 months
Submaximal exercise capacity
Time frame: through study completion, an average of 18 months
Peripheral Muscle Strength
Time frame: through study completion, an average of 18 months
Functional Status
Time frame: through study completion, an average of 18 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 2 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for COVID-19
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
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Başak KAVALCI KOL, Pt. MSc. principal investigator
Gazi University
Ece BAYTOK, Pt. MSc. principal investigator
Gazi University
Nilgün YILMAZ DEMİRCİ, Assoc. Prof. principal investigator
Gazi 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 COVID-19, run by Gazi 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 3 inclusion and 8 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 Aug 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?
Measurement of muscle oxygenation (SmO2) (time frame: through study completion, an average of 18 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 2 Aug 2023.