Chronic Fatigue in Sarcoidosis

Completed

• Conditions: Sarcoidosis
• Interventions: Diagnostic Test: fMRI, questionnaires, pneumologic diagnostics

• Registration Number: NCT04178239
• Lead Sponsor: RWTH Aachen University

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.

Study Timeline

• Study Start: 2017-03-10
• Primary Completion: 2018-02-02
• Study Completion: 2018-02-02
• Status Verified: 2019-11
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Chronic Fatigue	fMRI, questionnaires, pneumologic diagnostics	MFI score \< 54 points
Chronic Fatigue	fMRI, questionnaires, pneumologic diagnostics	MFI score \>53 points

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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).
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.
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.

Trial Locations

Locations (1)

University Hospital RWTH Aachen; 🇩🇪 Aachen, NRW, Germany