Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Measurement of aerobic exercise on cycloergometer.
- Who it may be relevant to
- Registry conditions: Spondyloarthritis, Axial, Fatigue, Exercise Capacity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This work will:
1. Study for the first time the implication of the objective skeletal muscular impact in fatigue during SA. 2. Better characterize the skeletal muscle impact of SA; 3. Characterize the evolution of the fatigue and the muscular impact under targeted therapy
Interventions
- Other Measurement of aerobic exercise on cycloergometer
The incremental effects tests will be performed in a service specialized in the exploration of the exercise (physiology or cardiology according to the centers) in a spacious and air-conditioned room, in the presence of a medical specialist. exercise and close to the resuscitation equipment. Before the test, weight and height will be collected. Information on the conduct of the test will be given to the patient. A multi-derivation ECG recording will be detected throughout the duration of the tes
Primary outcome measures
- Oxygen consumption capacity [Time frame: At inclusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Hôpitaux Universitaires de Strasbourg — Strasbourg
Identifiers
NCT: NCT03940911 · 7439