Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis
Paraules clau
Resum
Descripció
This work will:
1. • To study for the first time the implication of the objective skeletal muscular impact in fatigue during SA.
2. • To better characterize the skeletal muscle impact of SA;
3. • To characterize the evolution of the fatigue and the muscular impact under anti-TNFα treatment and the predictive factors of response,
4. • To identify new therapeutic targets for these two complications of SA, which currently have no specific treatment.
Dates
| Darrera verificació: | 04/30/2019 |
| Primer enviat: | 05/05/2019 |
| Inscripció estimada enviada: | 05/05/2019 |
| Publicat per primera vegada: | 05/06/2019 |
| Última actualització enviada: | 05/09/2019 |
| Publicació de l'última actualització: | 05/12/2019 |
| Data d'inici de l'estudi real: | 09/11/2019 |
| Data estimada de finalització primària: | 12/11/2019 |
| Data estimada de finalització de l’estudi: | 09/11/2022 |
Condició o malaltia
Intervenció / tractament
Other: Measurement of aerobic exercise on cycloergometer
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Other: anti-TNFα treatment and severe fatigue (FSS) See bellow (section "Interventions") the full description for
Measurement of aerobic exercise on cycloergometer
Measurement of muscle mass by two-photon absorptiometry: specific study
Measurement of Isometric Muscle Strength
Blood sampling for measurement of cytokine levels in the blood
Measurement of sedentarity
Psychological impact
Fatigue mesurement
Needle muscle of the vastus lateralis (This act will be limited to patients in care at Strasbourg University Hospital n=30) | |
| Other: anti-TNFα treatment and with mild fatigue (FSS <4) See bellow (section "Interventions") the full description for
Measurement of aerobic exercise on cycloergometer
Measurement of muscle mass by two-photon absorptiometry: specific study
Measurement of Isometric Muscle Strength
Blood sampling for measurement of cytokine levels in the blood
Measurement of sedentarity
Psychological impact
Fatigue measurement
Needle muscle of the vastus lateralis (This act will be limited to patients in care at Strasbourg University Hospital n=30) |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion criteria: -- Axial SA according to the ASAS criteria; - Indication to start a biotherapy; - ≥ 18 years old, no upper age limit; - Subject affiliated to a social health insurance reimbursement; - Subject having signed a dated and informed consent; - Woman in childbearing age: negative beta-HCG test and effective contraception; - Sufficient understanding of French to follow the protocol. Exclusion criteria: - Biologic treatments (ongoing or or taken during the 6 months preceding the study), - Associated extramuscular inflammatory disease (s) (excluding ocular and cutaneous involvement) eg chronic inflammatory bowel disease - Contraindication to the use of a biologic - Associated fibromyalgia (Questionnaire score FiRST ≥5) achieved during the V0 visit - History of coronary artery disease: exercise angina, acute coronary syndrome and / or coronary angioplasty, - History of lower extremity arterial disease: vascular claudication and / or lower extremity angioplasty - COPD - Neuromuscular pathology - Insufficiency of organ (renal, hepatic pulmonary heart) - Sleep apnea - Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.) - Subject under the protection of justice - Subject under guardianship or curatorship - Breastfeeding - Pregnancy - Subject in exclusion period defined by another clinical study or participating in a study likely to impact the results of the research - Corticosteroids in the 15 |
Resultat
Mesures de resultats primaris
1. Oxygen consumption capacity [At inclusion]
