ObjectiveTo assess the prevalence of PHD and chronic fatigue in Dutch TBI patients, and to study the relationships between the various aspects of chronic fatigue and PHD, with particular emphasis on the association between chronic fatigue, and…
ID
Source
Brief title
Condition
- Other condition
- Hypothalamus and pituitary gland disorders
- Structural brain disorders
Synonym
Health condition
persisternde cognitieve en fysieke vermoeidheid na letsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters
fatigue score (CIS20R Sub),
Secondary outcome
Severity of TBI (GOSE), demographic questionnaire, Cognition (TOSSA,TODA),
emotion and depression (HADS), general quality of life in TBI (QOLIBRI),
hypogonadism score (AMS), growth hormone deficiency related quality of life
(AGHDA-QOL), acceptance and coping (AAQ), sleep quantity and quality (Sleep
Q.), physical activity score ( FAI), physical performance (Åstrand), serum
hormone levels measured between 8.00 h and 10.00h AM (free T4, T3, TSH,
cortisol, ACTH, prolactin, sex hormones, SHBG, IGF-I, IGF-BP3), and the maximal
GH response to the growth-hormone releasing hormone-Arginine test (GHRH-Arg),
body composition by dual energy X-ray absorptiometry.
7 variables (cognition, emotional state, coping-acceptance state, condition,
sleep quality/quantity, activity state, hormonal state will be used tot
determine their contribution to the chronic post TBI fatigue.
Background summary
SUMMARY
Chronic Fatigue and Pituitary Hormone Deficiencies in Traumatic Brain Injury
Rationale
The incidence of traumatic brain injury (TBI) in the Netherlands is 187 per
100.000 inhabitants/year (19). TBI occurs more frequently in males than
females, the male to female ratio is 3:21 (19). Chronic fatigue will develop in
43 - 73% of cases (1). For the Netherlands this implies that 22.000 of the
yearly 30.000 TBI patients will develop chronic fatigue. It adversely affects
quality of life, often to a severe degree.
The aetiology of chronic fatigue in TBI is multi-factorial. It may be related
to cognitive impairment , (21,22), physical impairment (8), anxiety,
depression (15) and insomnia (13) .To some extent posttraumatic fatigue may
result from pituitary hormone deficiencies (PHD) caused by traumatic pituitary
damage3,4 (3,4,6,7,11,12,16,17,18). One year after TBI 22 -
37% of the patients has one or more PHD*s11 (7), the gonadal axis is involved
in 15% and 10 - 20% is growth hormone deficient13 (12). This high percentage of
PHD is explained by the effect of direct trauma or posttraumatic oedema which
may lead to interruption of the hypothalamo-hypophysial portal blood supply and
subsequent infarction of the pituitary12 (11).
In view of the high prevalence of PHD in TBI and the expectation that treatment
of PHD may substantially improve mental and physical performance, it has been
recommended that all TBI patients should be screened for PHD.10 However, at
present screening for PHD is not routinely performed in post TBI rehabilitation
centres. Consequently, PHD is likely to be under diagnosed, and many patients
will not receive adequate hormonal replacement therapy (HRT).
Study objective
Objective
To assess the prevalence of PHD and chronic fatigue in Dutch TBI patients, and
to study the relationships between the various aspects of chronic fatigue and
PHD, with particular emphasis on the association between chronic fatigue, and
gonadal and growth hormone deficiencies.
Study design
Study design cross-sectional observational study, a random sample from a
predefined population with TBI (sample size N=120), screened after at least one
year following TBI, using clinical assessment instruments and biochemical
analysis of hormonal parameters.
Study burden and risks
not applicable
Oudenoord 4
3513 ER Utrecht
NL
Oudenoord 4
3513 ER Utrecht
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria
* Patients treated in the TBI department of the rehabilitation centre of
Groot Klimmendaal between 2000 and 2008
* Males and females age 18 to 50 years.
* Confirmed diagnosis of previous TBI of at least one year
-TBI that required hospitalization
-originally diagnosed by neurological assessment and MRI or CT
-Extended Glasgow Coma Scale at time of inclusion >=5
* Subjects who are willing and able to comply with scheduled visits and
laboratory tests.
* Evidence of a personally signed and dated informed consent document
indicating that the subject or a legally acceptable representative has
been informed of all pertinent aspects of the trial.
Exclusion criteria
Exclusion criteria
* Hypothalamic/pituitary disease diagnosed prior to TBI
* Brain injury of non traumatic origin
* History of cranial irradiation
* Known drug or alcohol abuse
* Present or past non-TBI related medical (diagnosed by a medical
specialist) or psychiatric conditions (according to DSM IV criteria) that
impair the fulfilment of study requirements and/or interfere with the
evaluation of study objectives by probable independent effects on quality
of life or neuropsychological functioning.
* Severe neuromuscular disability or additional co-morbidity (heart,
pulmonary, kidney, and liver disease) which causes such a condition
deficit that it is impossible to fulfil the physical condition Åstrand test by
bike.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24522.072.08 |