Evaluating exercise response in chronic fatigue syndrome.
Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
This study is testing if a simple 6-minute walking test can help people with chronic fatigue syndrome understand their exercise limits without making their symptoms worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Escuela Universitaria de Fisioterapia de la Once Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT03675087 on ClinicalTrials.gov |
What this trial studies
This study assesses the relationship between the 6-minute walking test (6MWT) and peak cardiopulmonary exercise testing (CPET) in individuals with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Participants will undergo a baseline physical activity assessment, followed by the 6MWT, and then the peak CPET two weeks later to evaluate exercise tolerance without exacerbating symptoms. The goal is to determine if the 6MWT can effectively measure exercise capacity while minimizing post-exertional malaise, which is a common issue with CPET. This research aims to identify a less stressful alternative for evaluating exercise tolerance in CFS/ME patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic fatigue syndrome/myalgic encephalomyelitis by a qualified medical specialist.
Not a fit: Patients with primary psychiatric disorders, somatoform disorders, or substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for assessing exercise tolerance in patients with chronic fatigue syndrome.
How similar studies have performed: While similar approaches have been explored, this specific correlation between the 6MWT and CPET in CFS/ME patients has not been adequately evaluated in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madrid
- Escuela Universitaria de Fisioterapia de la ONCE — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Susana García-Juez — Escuela Universitaria de Fisioterapia de la Once
- Study coordinator: Susana García-Juez, Lecturer
- Email: sgj@once.es
- Phone: 915894500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.