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Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Strasbourg, France
NCT03940911 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Axial spondyloarthropathy (SpA) is the most common inflammatory rheumatism (1% of the general population) with important medico-economic consequences. Fatigue is a major feature of SA. It can be defined as a feeling of reduced muscle capacity, lack of energy and exhaustion. The fatigue reaches an abnormally high level (fatigue severity score (FSS) ≥4, called severe fatigue in this protocol) in more than two thirds of patients with SA. Skeletal muscle repercussions are present during SA. It is characterized by a decrease in exercise capacity independently of pain and ankylosis but is associated with a decrease in strength and muscle mass, the importance of which varies from one study to another. The link between fatigue (subjective sensation) and the skeletal muscular impact (objective) of SA has never been studied.

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📋 Eligibility rules (as published)
Inclusion criteria: * Axial SA according to the ASAS criteria; * Targeted therapy naïve patients * Indication to start a targeted therapy; * Initiation of targeted therapy ≤ 15 days before inclusion * ≥ 18 years old, no upper age limit; * Subject affiliated to a social health insurance reimbursement; * Subject able to understand the aims and risks of the research and having signed a dated and informed consent * Subject informed of the results of the preliminary medical examination * Woman in childbearing age: negative beta-HCG test and effective contraception; * Sufficient understanding of French to follow the protocol. Exclusion criteria: * Targeted therapy in progress for \> 15 days prior to inclusion * Contraindication to the use of targeted therapy * Systemic corticosteroids in the 15 days preceding the V0 visit * Associated extramuscular inflammatory disease (s) (excluding ocular and cutaneous involvement) eg chronic inflammatory bowel disease * 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
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What it tests

  • Measurement of aerobic exercise on cycloergometer
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Where

1 site
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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