Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
Recruiting now
Conditions studied: Fatigue Syndrome, Chronic
In brief
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.
Key facts
- Study ID
- NCT03675087
- Run by
- Escuela Universitaria de Fisioterapia de la Once
- People needed
- 22
- Starts
- 2019-02-27
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-03-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Escuela Universitaria de Fisioterapia de la ONCE — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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