NCT03675087Recruiting
Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
Source: ClinicalTrials.gov · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study evaluates the correlation between the 6-min walking test (6MWT) with gases measurement, and the peak cardiopulmonary exercise testing (CPET) using incremental cycling with gases and workload measurement, in order to determine if the 6MWT detects impairment in exercise tolerance and if it avoids the post-exertional malaise that the peak CPET causes on decreasing levels of physical activity, in participants affected by chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME). Physical activity level at baseline (usual activity, the parcipant will not be given any directions) will be recorded during 7 days, 24 hours/day. Afterwards, the 6MWT will be performed. After this test, the physical activity level will be collected again during 7 days, 24 hours/day. Peak CPET will be carried out 14 days after 6MWT to make sure that the basal levels are recovered, and finally, physical activity level will be collected again during 7 days, 24 hours/day.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 22 (estimated)
- First submitted
- 2 Sept 2018
- Start date
- 27 Feb 2019
- Primary completion date
- Jul 2025
- Lead sponsor
- Escuela Universitaria de Fisioterapia de la Once
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT03675087
What you commit to
- Study type: Observational
- Planned participants: 22
- From 27 Feb 2019 to the primary completion date, Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Present any of the absolute or relative contraindications, to perform exercise tests, described in previous investigations:
- Decompensated heart failure
- Acute myocardial infarction (less than 3 days)
- Syncope
- Unstable angina
- Cardiac arrhythmia poorly controlled
- Endocarditis, myocarditis or acute pericarditis
- Acute pulmonary edema
- Moderate or severe cardiac valvular stenosis
- Suspected dissection or dissecting aortic aneurysm
- O2 saturation at rest less than 85%
- Acute renal failure
- Untreated thyrotoxicosis
- Acute infection
- Uncontrolled hypertension (greater than 200-120 mmHg)
- Hypertrophic obstructive cardiomyopathy
- High-grade atrioventricular block
- Significant pulmonary arterial hypertension
- Advanced or risky pregnancy
- Significant diselectrolithmia
- Severe symptomatic aortic stenosis
- Severe anemia
- Pulmonary embolism
- Acute thrombophlebitis
- Traumatologic, orthopedic or neurological pathology that does not allow to walk or cycling.
- Psychic incapacity to understand the instructions of the tests.
- Present comorbidity of Multiple Chemical Sensitivity Syndrome.
- Have performed the peak incremental CPET in the last 3 years.
Other illness
- Present any of the diagnoses considered excluding of the CFS/ME, according to the international criteria recommended for clinical diagnosis and the selection of subjects for research:
- Primary psychiatric disorders
- Somatoform disorders
- or Substance abuse
Who the study is looking for
- To be diagnosed by a medical specialist in internal medicine with experience in this disease. For this, the participant must fulfill with the diagnostic criteria of CFS/ME, following the recommended criteria for the diagnosis of 2015.
- Prior signing of the informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Escuela Universitaria de Fisioterapia de la ONCE Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.