Validation of a repeated cardiopulmonary exercise test for the assessment of physical impairment in chronic fatigue syndrome.

Recruiting

• Conditions: Chronic Fatigue Syndrome; Myalgic Encephalopathy; 10029305; 10027665

• Registration Number: NL-OMON30595
• Lead Sponsor: CVS/ME Centrum Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

1. CFS/ME patients aged between 18 and 65 years.
2. History of CFS/ME according to Fukuda 1994-criteria:

A. Major Criteria: Clinically evaluated, unexplained, persistent or relapsing chronic fatigue that is of new or definite onset (has not been lifelong); is not the result of ongoing exertion; is not substantially relieved by rest; and results in substantial reduction in previous levels of occupational, educational, social or personal activities. ;B. Minor Criteria: The concurrent occurrence of four or more of the following symptoms, all of which must have persisted or recurred during six or more consecutive months of illness and must not have predated the fatigue;
- Self-reported impairment in short-term memory or concentration severe
enough to cause a substantial reduction in previous levels of occupational, educational, social or personal activities
- Sore throat
- Tender cervical or auxiliary lymph nodes
- Muscle pain
- Headaches of a new type, pattern or severity
- Unrefreshing sleep
- Post-exertional malaise lasting more than twenty-four hours.
- Multijoint pain without joint swelling or redness.;4.3 Inclusion criteria controls
1. Aged between 18 and 65 years.
2. No history of CF(S) according to CDC-criteria
3. Sedentary life, moderate exercise for 60 minutes or less, once a week.

Exclusion Criteria

a. According to CDC-criteria:
Any active medical condition that may explain the presence of chronic fatigue, such as untreated hypothyroidism, sleep apnea and narcolepsy, and iatrogenic conditions such as side effects of medication.
Any previously diagnosed medical condition whose resolution has not been documented beyond reasonable clinical doubt and whose continued activity may explain the chronic fatiguing illness. Such conditions may include previously treated malignancies and unresolved cases of hepatitis B or C virus infection.
Any past or current diagnosis of a major depressive disorder with psychotic or melancholic features; bipolar affective disorders; schizophrenia of any subtype; delusional disorders of any subtype; dementia*s of any subtype; anorexia nervosa; or bulimia nervosa.
b. Any disease or condition that, judged by the Investigator, could imply a potential hazard to the patient, and interfere with the trial participation or trial outcome.
i. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
j. Previous participation in this trial.
m. Diagnosis of fibromyalgia.;Exclusion criteria controls;As for CFS participants, except criterion 1.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change of anaerobic threshold in second test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Maximal oxygen uptake.<br /><br>Oxygen uptake at the anaerobic threshold.</p><br>