We need objective and validated tests for the assessment of the severity of impairment in CFS/ME patients. In 2 areas these tests will be essential: for studies of the effect of interventions and for the assessment of disability.Hardly any research…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change of anaerobic threshold in second test.
Secondary outcome
Maximal oxygen uptake.
Oxygen uptake at the anaerobic threshold.
Background summary
During the last years our knowledge of the Chronic Fatigue Syndrome / Myalgic
Encephalopathy has increased. Only 10 years ago the syndrome was supposed to be
psychogenic, but now it is considered to be a neurological disease with
demonstrable anatomical, biochemical, functional and immunological
disturbances. Developments in technique made this possible.
Okada et al. reported in 2004 a reduction of gray matter in the brain of CFS/ME
patients. The reduction was related to the physical condition. De Lange et al.
confirmed this finding in 2005. Chaudhuri and Behan (2004) described an
increase of choline in the brain. Nestadt et al. reported a threefold increase
in the lactate concentration in the ventricles of the brain of CFS/ME patients
at the 8th conference of the IACFS in 2007. Lange et al. explained the problem
of processing of auditory information by demonstrating an increase of the use
of brain regions. Natelson et al. demonstrated immune activity in the liquor of
the brain. The techniques that were used in this research are not available in
clinical practice yet. We will still need to use the subjective symptoms that
were defined in 1994 by Fukuda et al.
Study objective
We need objective and validated tests for the assessment of the severity of
impairment in CFS/ME patients. In 2 areas these tests will be essential: for
studies of the effect of interventions and for the assessment of disability.
Hardly any research of medical interventions was reported in recent years due
to the lack of objective and clinical relevant endpoints. Questionnaires were
validated, but they are always subjective.
New rules for the assessment of disability and compensation in the Netherlands
require objective and validated criteria. At the moment it is unclear what the
physical and cognitive impairment is that CFS/ME patients report. This
communications needs to be objectivated and standardized.
Study design
In this study we will use a maximal test on the bicycle ergometer to test the
physical condition and repeat the test after 24 hours for the assessment of
recovery.
The oxygen uptake at maximal effort and at the anaerobic threshold is used to
measure the physical condition. We and others found a reduction of the
anaerobic threshold during a second maximal test after 24 hours in a major
subgroup of CFS/ME patients.
Study burden and risks
All participants are requested to exercise at maximum effort. This will cause
exhaustion and muscle discomfort. A properly carried out test has no additional
risk.
Waalstraat 25 - 31
1078 BR Amsterdam
Nederland
Waalstraat 25 - 31
1078 BR Amsterdam
Nederland
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL16031.040.07 |