Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468722
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Fat Oxidation Capacity in Patients With Post Covid-19 Syndrome
Sponsor:
University of WittenHerdecke
Organization:
University of WittenHerdecke
Study Overview
Official Title:
Analysis of Fat Oxidation Capacity During Cardiopulmonary Exercise Testing Indicates Long-lasting Metabolic Disturbance in Patients With Post-COVID-19 Syndrome
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None