Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Measurement of aerobic exercise on cycloergometer
Treatment groups
122 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov