Evaluating exercise response in chronic fatigue syndrome.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.