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

Launched by ESCUELA UNIVERSITARIA DE FISIOTERAPIA DE LA ONCE · Sep 14, 2018

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how individuals with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) respond to exercise. Researchers want to see if a simple walking test, called the 6-minute walking test (6MWT), can effectively measure how well patients tolerate exercise compared to a more intense cycling test known as cardiopulmonary exercise testing (CPET). The goal is to find out if the walking test can identify exercise limitations without causing the worsening of symptoms that often follows more strenuous activity.

To participate in this study, individuals must be diagnosed with CFS/ME by a qualified doctor and be between the ages of 18 and 74. Participants will first record their usual activity levels for a week, then complete the 6MWT, and after a brief recovery period, undergo the CPET. Throughout the study, activity levels will continue to be monitored, allowing researchers to gather valuable information about exercise tolerance and symptom flare-ups. It's important to note that certain medical conditions could prevent someone from participating, so a thorough health screening will be conducted before enrollment. If you're interested or think you might qualify, please speak with your healthcare provider for more details.

Gender

ALL

Eligibility 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.