G35.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Declaration of no-objection concerning study participation by a physician - EDSS = 4 - Approved RRMS
Exclusion criteria
Exclusion criteria: - Acute episode or exacerbation of multiple sclerosis symptoms during intervention - Concomitant disease state (medical/ neurological) affecting study endpoints (e.g., tumor diseases) - Cardio-vascular or orthopedic diseases excluding from the exercise program - Pregnancy or breast feeding - Adjustments in MS-specific medication within 12 weeks prior to participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| kynurenine/tryptophan ratio (measured in blood serum at all 4 measurement time points) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Immune cell populations (measured in whole blood/isolated lymphocytes at all 4 measurement time points): CD4+ T helper cells (Tregs, Th17, Th17.1, Th1, Tfh), CD8+ T cells, B cells, NK cells, Neutrophils, Monocytes - peripheral neurofilament light chain and Glial Fibrillary Acidic Protein (measured in blood serum at all 4 measurement time points) - Metabolites of the kynurenine pathway (measured in blood serum at all 4 measurement time points): Kynurenic acid, quinolinic acid, anthranilic acid, 3-hydroxykynurenine, xanthurenic acid, 3-hydroxyanthranilic acid, cinnabaric acid, picolinic acid, quinolinic acid, nicotinic acid, Nicotinamide N1-methyl-nicotinamide, 3-indoxyl sulphate, indole-3-acetamide, indole-3-acetate, indole-3-acetaldehyde, indole-3-aldehyde, indole-3-lactate, indole-3-acrylate and indole-3-propionate - Mediators of the kynurenine pathway (measured in blood serum at all 4 measurement time points): IL-4, IL-6, IL-10, TGF-, IL-17, IFN-?, TNF-a, cortisol - Enzymes, receptors and transporters of the kynurenine pathway (measured intracellularly at all 4 measurement time points): TDO, IDO1, KMO, KAT1-KAT4, IL4I1, AhR, SLC7A5 and CYP1A1 - Body constitution using bioimpedance analysis - Cognitive testing using the Symbol Digit Modalities Test - Fatigue using the Fatigue Scale for Motor and Cognitive Functions questionnaire - Quality of life using the Multiple Sclerosis International Questionnaire of Quality of Life - Cardiovascular fitness using spiroergometry (bicycle ergometer) | — |
Countries
Germany
Contacts
Technische Universität Dortmund