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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

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME), diagnosed by an internal medicine specialist. It compares two exercise tests.

Age
18 to 65 years
Sex
All sexes
Disease stage
Chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME), diagnosed by a medical specialist in internal medicine with experience in this disease, using the 2015 diagnostic criteria.
Earlier treatment
Must not have had a peak incremental cardiopulmonary exercise test in the last 3 years.

Main reasons for not taking part

  • Primary psychiatric disorders, somatoform disorders or substance abuse
  • Heart or lung conditions that make exercise tests unsafe, such as decompensated heart failure, unstable angina or pulmonary embolism
  • Acute infection or acute kidney failure
  • Advanced or risky pregnancy
  • Bone, joint or nerve problems that prevent walking or cycling

Read by machine on 12 November 2026.

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, SpainContact: Susana García-Juez, LecturerTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT03675087