Ireland
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Recruiting Observational

Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.

NCT03675087 · tracked via the Priya Life Science Spain tracker
Sponsor
Escuela Universitaria de Fisioterapia de la Once
Phase
Observational
Started
2019-02-27
Last updated
2025-03-10

Condition(s) studied

Fatigue Syndrome, Chronic

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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 * 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.

Primary outcome measure(s)

  • Mean Value of the Peak VO2 in both Exercise Tests (6MWT and Peak CPET) in Milillitres/ Minute. — 3 hours one day and 2 hours another day.
    The portable spirometer Oxycon Mobile CPET from JaegerTM during 6MWT or the fixed spirometer Mijnhart Oxycon during peak CPET will be used for its measuring. Those instruments are validated. Mean and standard deviation will be calculated.

Trial sites (1)

FacilityCityRegionStatus
Escuela Universitaria de Fisioterapia de la ONCE Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03675087 on ClinicalTrials.gov ↗ ← All trials in Spain