Evaluating exercise capacity and symptom triggers in Long COVID patients
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
This study is trying to see how well two different exercise tests can help people with Long COVID understand their exercise limits and what triggers their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 2 sites (Jette, Brussels and 1 other locations) |
| Trial ID | NCT06933017 on ClinicalTrials.gov |
What this trial studies
This study evaluates exercise capacity and identifies causes of Post-Exertional Symptom Exacerbation (PESE) in individuals suffering from Long COVID. Participants will undergo two different exercise tests, the Two-Day 6-Minute Incremental Step Test (6MIST) and the Cardiopulmonary Exercise Test (CPET), to compare their effectiveness in detecting PESE. The study will also assess various factors such as metabolism, mitochondrial function, and psychological aspects, using questionnaires and advanced measurement techniques. Each test will be conducted over two consecutive days, with a one-month gap between tests to observe delayed symptom responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the WHO criteria for Long COVID and experience PESE.
Not a fit: Patients with pre-existing conditions that could explain their symptoms or those unable to perform the required exercise tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of Long COVID symptoms, particularly PESE.
How similar studies have performed: While there is ongoing research into Long COVID, this specific approach combining exercise testing and causal modeling is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jette, Brussels and 1 other locations
- Universitair Ziekenhuis Brussel — Jette, Brussels, Belgium (Recruiting)
- Universitair Ziekenhuis Brussel — Brussels, Jette, Belgium (Recruiting)
Study contacts
- Principal investigator: Elisabeth De Waele, MD, PhD — Universitair Ziekenhuis Brussel
- Study coordinator: Sarah Bomans, Master of Science
- Email: sarah.bomans@uzbrussel.be
- Phone: +32 2 474 93 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.