Post-COVID-19 SyndromeNCT06468722
Fat Oxidation Capacity in Patients With Post Covid-19 Syndrome
An observational study of Post-COVID-19 Syndrome and Long-COVID-19 Syndrome, run by University of Witten/Herdecke at 1 site in Germany.
Trial summary
Post-COVID-19 Syndrome (PCS) is characterized by symptoms, including fatigue, reduced physical performance, dyspnea, cognitive impairment, and psychological distress. The mechanisms underlying the onset and severity of PCS point to mitochondrial dysfunction as significant contributor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome, Long-COVID-19 Syndrome
- What is being tested?
- Exercise-based rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 187 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 21 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Post-COVID-19 syndrome who are referred to Clinic Königsfeld for inpatient medical rehabilitation and who are willing to participate in the study and give their written informed consent. Inclusion criteria were a history of (at least one) COVID-19 infection (positive PCR test at the time of infection), and ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment.
Who may be able to join
- a history of (at least one) Covid-19 infection
- ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment
- referral to inpatient rehabilitation
- signed informed consent
Who cannot join
- unstable condition
- incapable of understanding study information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Fat Oxidation Capacity During Cardiopulmonary Exercise Testing Indicates Long-lasting Metabolic Disturbance in Patients With Post-COVID-19 Syndrome
Post-COVID-19 Syndrome (PCS) is characterized by symptoms, including fatigue, reduced physical performance, dyspnea, cognitive impairment, and psychological distress. The mechanisms underlying the onset and severity of PCS point to mitochondrial dysfunction as significant contributor. This study examined fat oxidation as a function of mitochondrial capacity during exercise.
Read the detailed description
Post-COVID-19 Syndrome (PCS), also known as post-acute sequelae of COVID-19, manifests following an acute infection with the SARS-CoV-2 virus (COVID-19 infection). PCS is characterized by the persistence of symptoms beyond 12 weeks from the onset of infection and/or the emergence of new symptoms within this time. Although recent guidelines offer specific criteria to diagnose PCS, ambiguity persists due to the complex nature of its symptomatology and the lack of definitive diagnostic tools. PCS is a multisystemic disorder characterized by symptoms such as (chronic) fatigue, diminished physical performance, muscular weakness and pain, dyspnea, cognitive impairments and alterations of the autonomous nervous system, as well as mental and psychological distress. The severity of symptoms varies widely among patients, from mild impairment to significant restrictions in daily activities, potentially leading to partial or complete incapacity to work. Of note, the severity of the acute infection does not predict the onset or severity of PCS. Even though many patients experience gradual recovery without specific treatment, there is a substantial need for effective medical rehabilitation, especially for those with persistent PCS. To this respect, exercise-based programs have been shown to induce significantly exercise capacity as well as higher quality of life, reduced fatigue, and less depression. Despite ongoing investigations, the mechanisms contributing to the onset and severity of PCS remain largely unknown. Factors may include endothelial dysfunction and detrimental effects on the microvasculature, as well as a "cytokine storm" associated with excessive oxidative stress and subsequent mitochondrial dysfunction which has emerged as a significant potential contributor.
Notably, detrimental effects on mitochondrial function have been described as a result of severe acute infections triggering an excessive immune response, systemic inflammation and oxidative stress. Recent studies suggested that impaired mitochondrial function in PCS may be associated with impaired fatty acid oxidation (FatOx) which can be identified using cardiopulmonary exercise testing (CPET). Currently, the number of PCS patients characterized for changes in FatOx using CPET is low and associations with signs and symptoms of PCS such as fatigue have not been reported in detail. Moreover, reports on the potential of exercise-based rehabilitation to restore FatOx capacity in PCS are not available. Thus, the current study aimed to investigate if analysis of breath-by-breath spirometric data followed by an estimation of individual FatOx capacity can be used for the stratification of PCS patients. The investigators hypothesized that a lower FatOx potential would be associated with PCS-specific signs and symptoms such as mental and physical fatigue. In addition, the investigators sought to analyze if exercise-based rehabilitation would be effective in restoring PCS patients' FatOx capacity as a sign of improved mitochondrial function.
- Conditions
- Post-COVID-19 Syndrome, Long-COVID-19 Syndrome
- Being tested
- Exercise-based rehabilitation
- Keywords
- SARS-CoV-2, Long-COVID-19, Exercise-based Rehabilitation, Mitochondrial Dysfunction, Fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mitochondrial Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based rehabilitationBehavioural
Patients performed regular physical exercise during inpatient rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Post-Covid-19 Syndrome Patients | Not described Receives: Behavioral: Exercise-based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Oxidation Rate
Fat oxidation will be assessed by breath-by-breath spiroergometry
Measured: Baseline and week 4 (i. e. before discharge)
Secondary outcomes (2)
Change in Carbohydrate Oxidation Rate
Carbohydrate oxidation rate will be assessed by breath-by-breath spirometry
Measured: Baseline and week 4 (i. e. before discharge)
Change in Fatigue
Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)"
Measured: Baseline and week 4 (i. e. before discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Apr 2021
- Primary completion30 Jun 2023
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Rehabilitationsforschung Norderney
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468722
- Sponsor's protocol ID
- PCS_Fettoxidation
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garbsch R, Schafer H, Mooren FC, Schmitz B. Analysis of fat oxidation capacity during cardiopulmonary exercise testing indicates long-lasting metabolic disturbance in patients with post-covid-19 syndrome. Clin Nutr. 2024 Dec;43(12):26-35. doi: 10.1016/j.clnu.2024.10.010. Epub 2024 Oct 11.
PubMed 39423759
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Fat Oxidation Capacity During Cardiopulmonary Exercise Testing Indicates Long-lasting Metabolic Disturbance in Patients With Post-COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT06468722
- Acronym / sponsor ID
- PCS_Fettoxidation
- Conditions
- Post-COVID-19 Syndrome, Long-COVID-19 Syndrome
- Keywords
- SARS-CoV-2, Long-COVID-19, Exercise-based Rehabilitation, Mitochondrial Dysfunction, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Institut für Rehabilitationsforschung Norderney
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 21 Jun 2024 (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.
Post-COVID-19 Syndrome (PCS) is characterized by symptoms, including fatigue, reduced physical performance, dyspnea, cognitive impairment, and psychological distress. The mechanisms underlying the onset and severity of PCS point to mitochondrial dysfunction as significant contributor. This study examined fat oxidation as a function of mitochondrial capacity during exercise.
Detailed description
Post-COVID-19 Syndrome (PCS), also known as post-acute sequelae of COVID-19, manifests following an acute infection with the SARS-CoV-2 virus (COVID-19 infection). PCS is characterized by the persistence of symptoms beyond 12 weeks from the onset of infection and/or the emergence of new symptoms within this time. Although recent guidelines offer specific criteria to diagnose PCS, ambiguity persists due to the complex nature of its symptomatology and the lack of definitive diagnostic tools. PCS is a multisystemic disorder characterized by symptoms such as (chronic) fatigue, diminished physical performance, muscular weakness and pain, dyspnea, cognitive impairments and alterations of the autonomous nervous system, as well as mental and psychological distress. The severity of symptoms varies widely among patients, from mild impairment to significant restrictions in daily activities, potentially leading to partial or complete incapacity to work. Of note, the severity of the acute infection does not predict the onset or severity of PCS. Even though many patients experience gradual recovery without specific treatment, there is a substantial need for effective medical rehabilitation, especially for those with persistent PCS. To this respect, exercise-based programs have been shown to induce significantly exercise capacity as well as higher quality of life, reduced fatigue, and less depression. Despite ongoing investigations, the mechanisms contributing to the onset and severity of PCS remain largely unknown. Factors may include endothelial dysfunction and detrimental effects on the microvasculature, as well as a "cytokine storm" associated with excessive oxidative stress and subsequent mitochondrial dysfunction which has emerged as a significant potential contributor.
Notably, detrimental effects on mitochondrial function have been described as a result of severe acute infections triggering an excessive immune response, systemic inflammation and oxidative stress. Recent studies suggested that impaired mitochondrial function in PCS may be associated with impaired fatty acid oxidation (FatOx) which can be identified using cardiopulmonary exercise testing (CPET). Currently, the number of PCS patients characterized for changes in FatOx using CPET is low and associations with signs and symptoms of PCS such as fatigue have not been reported in detail. Moreover, reports on the potential of exercise-based rehabilitation to restore FatOx capacity in PCS are not available. Thus, the current study aimed to investigate if analysis of breath-by-breath spirometric data followed by an estimation of individual FatOx capacity can be used for the stratification of PCS patients. The investigators hypothesized that a lower FatOx potential would be associated with PCS-specific signs and symptoms such as mental and physical fatigue. In addition, the investigators sought to analyze if exercise-based rehabilitation would be effective in restoring PCS patients' FatOx capacity as a sign of improved mitochondrial function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Covid-19 Syndrome Patients | – | Behavioral: Exercise-based rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Post-COVID-19 syndrome who are referred to Clinic Königsfeld for inpatient medical rehabilitation and who are willing to participate in the study and give their written informed consent. Inclusion criteria were a history of (at least one) COVID-19 infection (positive PCR test at the time of infection), and ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment.
Key inclusion criteria (4 listed)
- a history of (at least one) Covid-19 infection
- ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment
- referral to inpatient rehabilitation
- signed informed consent
Key exclusion criteria (2 listed)
- unstable condition
- incapable of understanding study information
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 |
|---|---|---|
| Exercise-based rehabilitationPatients performed regular physical exercise during inpatient rehabilitation | Behavioural | Post-Covid-19 Syndrome Patients |
Primary outcome
Change in Fat Oxidation Rate
Time frame: Baseline and week 4 (i. e. before discharge)
Fat oxidation will be assessed by breath-by-breath spiroergometry
2 secondary outcomes
Change in Carbohydrate Oxidation Rate
Time frame: Baseline and week 4 (i. e. before discharge)
Change in Fatigue
Time frame: Baseline and week 4 (i. e. before discharge)
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 25 Jun 2024.
- Derived from this study: PubMed 39423759Garbsch R, Schafer H, Mooren FC, Schmitz B. Analysis of fat oxidation capacity during cardiopulmonary exercise testing indicates long-lasting metabolic disturbance in patients with post-covid-19 syndrome. Clin Nutr. 2024 Dec;43(12):26-35. doi: 10.1016/j.clnu.2024.10.010. Epub 2024 Oct 11.
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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?
An observational study of Post-COVID-19 Syndrome and Long-COVID-19 Syndrome, run by University of Witten/Herdecke at 1 site in Germany.
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 4 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 25 Jun 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 Germany. 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?
Change in Fat Oxidation Rate (time frame: Baseline and week 4 (i. e. before discharge)). 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 NCT06468722, which also lists 1 linked publication.
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 25 Jun 2024.