Official Title
Feasibility Study of the Augmented Two-Day 6-Minute Incremental Step Test and Causal Exploration Through a Directed Acyclic Graph and Structural Equation Model for Post-Exertional Symptom Exacerbations in Long COVID Patients
Brief Summary

This study aims to evaluate exercise capacity and identify causes of Post-ExertionalSymptom Exacerbation (PESE) in individuals with Long COVID. The investigators willcompare the effectiveness of the Two-Day 6-Minute Incremental Step Test (6MIST) and theCardiopulmonary Exercise Test (CPET) in detecting PESE. Additionally, the investigatorswill assess metabolism, mitochondrial function, autonomic symptoms, psychologicalfactors, and physical activity. Participants will complete both the Two-Day 6MIST and theTwo-Day CPET, with a one-month gap between them. Each test is performed on twoconsecutive days to assess the delayed symptom response. The subjective symptoms of PESEwill also be measured through questionnaires. To explore potential causes of PESE, theinvestigators will measure metabolism using indirect calorimetry, bioelectrical impedanceanalysis and food diaries, mitochondrial dysfunction with NIRS technology, autonomicsymptoms using the COMPASS-31 questionnaire, psychological factors with questionnairesand physical activity levels using an activity tracker. This study will determine if theTwo-Day Step Test (6MIST) is a feasible alternative to the two-day CPET for measuringPESE and will help uncover underlying mechanisms contributing to symptom exacerbation.

Detailed Description

Not Provided

Recruiting
Long Covid

Device: Portable mask for respiratory gas analysis

This is a portable mask, which is connected to the SplendoHealth app. The Polar sens 10
heartrate monitor and TrainRed NIRS device are also connected to this app. The three
devices (mask, heartrate monitor and NIRS) are measuring respiratory gases, heart rate
and muscle tissue oxygenation simultanuously and at the end of the 6 min step test, you
get an individual cardiorespiratory fitness report.
Other Name: SplendoHealth app

Device: Cardio-pulmonary exercise test

Golden standard for measuring PEM: the double cardio-pulmonary exercise test on a bike.
Other Name: CPET

Eligibility Criteria

Inclusion Criteria:

- ≥18 years old

- Long COVID patients following the World Health Organization (WHO) criteria: "the
continuation or development of new symptoms 3 months after the initial SARS-CoV-2
infection, with these symptoms lasting for at least 2 months with no other
explanation"

- Previously active as described in the WHO recommendations for physical activity
(minimal 150 minutes/week of moderate intensity aerobic physical activity OR minimal
75 minutes of vigorous intensity activity/week OR an equivalent combination of
moderate- and vigorous-intensity activity throughout the week)

- Patient suffers from PESE as defined by the DePaul Symptom Questionnaire PEM
(Post-Exertional Malaise) subscale

- Able to understand and sign written informed consent in Dutch, French or English

Exclusion Criteria:

- Any pre-existing conditions or new medical diagnosis that can alternatively explain
the current symptoms

- Being unable to perform a cycle ergometer test as decided upon by the medical study
team members

- Suffering from Chronic Obstructive Pulmonary Disease (COPD) GOLD classification
category 2,3 or 4 (by the Global Initiative for Chronic Obstructive Lung Disease)

- Allergies to medical adhesive bandages

- Skin conditions aggravated by sunlight including Porphyria

- Participation in other interventional trials

- Mitochondrial diseases

- Pregnancy

- Lactation

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Belgium
Locations

Universitair Ziekenhuis Brussel
Jette, Brussels, Belgium

Universitair Ziekenhuis Brussel
Brussels, Jette, Belgium

Contacts

Sarah Bomans, Master of Science
+32 2 474 93 31
sarah.bomans@uzbrussel.be

Elisabeth De Waele, MD, PhD
+32 2 476 33 54
elisabeth.de.waele@uzbrussel.be

Elisabeth De Waele, MD, PhD, Principal Investigator
Universitair Ziekenhuis Brussel

Vrije Universiteit Brussel, Jette, Belgium
NCT Number
Keywords
long COVID
PEM
Post-exertional malaise
CPET
6MIST
Fatigue
MeSH Terms
Post-Acute COVID-19 Syndrome
Symptom Flare Up