Actively Recruiting
Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
Led by Escuela Universitaria de Fisioterapia de la Once · Updated on 2025-03-10
22
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
Sponsors
E
Escuela Universitaria de Fisioterapia de la Once
Lead Sponsor
H
Hospital Universitario La Paz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic fatigue syndrome/myalgic encephalomyelitis by a medical specialist in internal medicine experienced in this disease, following the 2015 recommended diagnostic criteria
- Signed informed consent prior to participation
You will not qualify if you...
- Diagnosed with primary psychiatric, somatoform disorders, or substance abuse
- Conditions contraindicating exercise tests, including decompensated heart failure, recent acute myocardial infarction (less than 3 days), syncope, unstable angina, poorly controlled cardiac arrhythmia, endocarditis, myocarditis, acute pericarditis, acute pulmonary edema, moderate or severe cardiac valvular stenosis, suspected aortic dissection, resting oxygen saturation below 85%, acute renal failure, untreated thyrotoxicosis, acute infection, uncontrolled hypertension (over 200/120 mmHg), hypertrophic obstructive cardiomyopathy, high-grade atrioventricular block, significant pulmonary arterial hypertension, advanced or risky pregnancy, significant electrolyte imbalance, severe symptomatic aortic stenosis, severe anemia, pulmonary embolism, acute thrombophlebitis
- Traumatologic, orthopedic, or neurological conditions preventing walking or cycling
- Inability to understand test instructions due to psychiatric incapacity
- Comorbidity with Multiple Chemical Sensitivity Syndrome
- Having performed peak incremental CPET in the last 3 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Escuela Universitaria de Fisioterapia de la ONCE
Madrid, Spain, 28034
Actively Recruiting
Research Team
S
Susana García-Juez, Lecturer
CONTACT
I
Irene Rodríguez-Andonaegui, Lecturer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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