Compares two exercise tests in people with chronic fatigue syndrome
Compares a walking test with a cycling exercise test in adults with ME/CFS.
Plain-language title generated from the registry record
Registry title: Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
Key facts
- Where
- Madrid, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT03675087, who can take part
Where in Spain
- Escuela Universitaria de Fisioterapia de la ONCEMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Escuela Universitaria de Fisioterapia de la Once
- Trial code
- NCT03675087
- Record updated
- 10 March 2025
- Original description
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).Read full original descriptionShow less
Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
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.
Inclusion: 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.
Exclusion: 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; 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.