NCT06468722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

June 19, 2024

Last Update Submit

June 21, 2024

Conditions

Keywords

SARS-CoV-2Long-COVID-19Exercise-based RehabilitationMitochondrial DysfunctionFatigue

Outcome Measures

Primary Outcomes (1)

  • Change in Fat Oxidation Rate

    Fat oxidation will be assessed by breath-by-breath spiroergometry

    Baseline and week 4 (i. e. before discharge)

Secondary Outcomes (2)

  • Change in Carbohydrate Oxidation Rate

    Baseline and week 4 (i. e. before discharge)

  • Change in Fatigue

    Baseline and week 4 (i. e. before discharge)

Study Arms (1)

Post-Covid-19 Syndrome Patients

Behavioral: Exercise-based rehabilitation

Interventions

Patients performed regular physical exercise during inpatient rehabilitation

Post-Covid-19 Syndrome Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • unstable condition
  • incapable of understanding study information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic Königsfeld

Ennepetal, North Rhine-Westphalia, 58256, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeMitochondrial DiseasesFatigue

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 21, 2024

Study Start

April 1, 2021

Primary Completion

June 30, 2023

Study Completion

May 21, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations