Sarcoidosis
Conditions
Keywords
Fatigue, fMRI
Brief summary
Background: Chronic fatigue (CF) is a prominent symptom in many sarcoidosis patients, affecting quality of life (QoL) and interfering with treatment. This study investigates neuropsychobiological mechanisms and markers of CF in sarcoidosis.
Detailed description
Patients with a histological diagnosis of sarcoidosis are included. The Multidimensional Fatigue Inventory (MFI) is used to define patients with and without CF. All patients are then characterized using several fatigue, depression, QoL and executive functioning questionnaires. Cognitive functioning and underlying neural correlates are assessed using an n-back task measuring working memory and (sustained) attention during functional magnetic resonance imaging (fMRI). Sarcoidosis disease activity is determined using lung function, laboratory parameters, and exercise capacity.
Interventions
DIAGNOSTIC_TESTfMRI, questionnaires, pneumologic diagnostics
fMRI neuropsychological questionnaires pneumologic diagnostics: blood samples, whole body plethysmography, walking test
Sponsors
RWTH Aachen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically diagnosed sarcoidosis * age ≥18 years * provision of written informed consent * sufficient German language skills to fully understand all questionnaires
Exclusion criteria
* patients unable to understand study-related information * insufficient language skills in German language * MRI-related contraindications: * any kind of implants or extraneous material inside the body * past thoracic or ophthalmologic surgery * medical history of epilepsy, tinnitus or seizure * extensive tattoos * current pregnancy * claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity | 1 day of study participation | Measured by a Fatigue questionnaire that has frequently been used in cohorts of sarcoidosis patients, the Multidimensional Fatigue Inventory (MFI). It consists of 20 items. For each item a score of 1 to 5 is possible, resulting in a total score of 20-100. Higher scores indicate a higher level of fatigue. In this study fatigue is diagnosed in patients with a total score of \>53 based on the 75th percentile of norm values as primary developed by Kuhnt et al and used in several studies with cohorts of sarcoidosis patients. |
| Fatigue | 1 day of study participation | In addition to the MFI the Fatigue Assessement Scale (FAS) is performed. It is frequently used in cohorts of sarcoidosis patients. With its 10 Items the possible total score varies from 10 to 50, higher scores indicate more fatigue. |
| Impact of fatigue on health-related quality of life | 1 day of study participation | Assessed by the Fatigue Impact Scale (FIS). It includes 40 items resulting in a total score from 0 to 160. Higher values indicate more fatigue. |
| Cognitive functioning and underlying neural correlates | 1 day of study participation | Assessed by an n-back task measuring working memory and (sustained) attention during functional magnetic resonance imaging. Reaction times and hit rates are measured. |
| Sarcoidosis disease activity | 1 day of study participation | Is assessed by s-IL2-receptor (U/ml), ACE-polymorphism (mU/L) and Neopterin (nmol/L) values from a blood sample. Higher values indicate a higher sarcoidosis disease activity. |
| Lung function assessement | 1 day of study participation | Whole body plethysmography is performed according to current recommendations. Parameters measured include total lung capacity (% predicted), vital capacity (% predicted), FEV1 (% predicted) and DLCO (% predicted). |
| Exercise Capacity | 1 day of study participation | Assessed by a standardised six-minute walking test. Walking distance the patient achieves within six minutes is assessed. |
| Quality of life (self-assessment) | 1 day of study participation | Assessed by the World Health Organization quality of Life Questionnaire, short form (WHO-QOL-BREF). The included Items assess aspects of quality of life in different domains: physical health domain, psychologic health domain, social relationships domain, environmental health domain, global domain. Domain scores are scaled in a positive direction, therefore higher scores denote higher quality of life. Scores from 0 to 100 are possible in each domain. |
| Depression (self-assessment) | 1 day of study participation | Patients are asked to perform the ADS (Allgemeine Depressionsskala). A total score from 0 to 60 points is possible, while higher scores indicate more signs and symptoms of depression. |
| Depression (third-party-assessment) | 1 day of study participation | Assessed by the Hamilton Depression Scale (HAMD). A total score of 0 to 62 points is possible with higher scores indicating more signs and symptoms of depression. |
| Anxiety | 1 day of study participation | Assessed by the State-Trait-Anxiety-Inventory (STAI). It consists of two subscales, each including 20 items. For each subscale there is a possible score from 20 to 80 points with higher scores indicating more anxiety. |
| Executive functioning | 1 day of study participation. | Assessed by the Trail-Making-Test (TMT-A and -B). Time necessary for completion of the task is measured, shorter periods of time indicate a better executive functioning in terms of attention. |
Countries
Germany
Outcome results
None listed