persisternde cognitieve en fysieke vermoeidheid na letsel fatigue traumatic brain injury
Conditions
Interventions
None listed
Sponsors
Revalidatiecentrum Groot Klimmendaal Arnhem en ziekenhuis Rijnstate Arnhem
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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: 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters fatigue score (CIS20R Sub), | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed