CompletedNot Applicable

Feasibility of an Augmented Two-Day Step Test and Causal Modeling for Post-Exertional Symptom Exacerbation in Post Covid-19 Syndrome

Belgium25 participantsStarted 2025-03-20

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Difference in oxygen uptake at peak (VO2 peak) between day 1 and day 2 measured with the CPET compared to measured with the Calibre device

Timeframe: From day 1 and day 2 of experimental session 1 to day 1 and day 2 of experimental session 2, one month apart (±10 days)

Difference in Rate of Perceived Exertion (RPE) measured with the CPET compared to measured with the Calibre device

Timeframe: RPE will be measured during two experimental sessions, each with two days, one month apart. On day 1, RPE is recorded 15 minutes (±15 min) before and after the test. On day 2, RPE is measured 24 hours (±120 min) after test 1 and before test 2.]

Resting Energy Expenditure (kcal/kg/day), measured through Indirect Calorimetry (IC)

Timeframe: Baseline (measured once, during the first study visit)

Total Energy Expenditure (TEE) in kcal/kg/day, measured through Indirect Calorimetry (IC)

Timeframe: Baseline (measured once during the first study visit)

Phase angle (degrees), measured through Bioelectrical Impedance Analysis (BIA)

Timeframe: Baseline (measured once during the first study visit)

Muscle mass (kg/m2), measured through Bioelectrical Impedance Analysis (BIA)

Timeframe: Baseline (measured once during the first study visit)

Trial details

NCT IDNCT06933017

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-03

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