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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Measurement of aerobic exercise on cycloergometer
Other interventionThe 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 test and followed by a physician experienced in the ECG effort. O2 saturation by oximetry of hens will be recorded continuously. Blood pressure will be recorded at each level. The collection of expired gases in the face mask whose tightness will be verified to measure the fractions inspired and expired in O2 and CO2 (Sensor Medics Vmax229, Yorba Linda, CA, USA) and calculations VO2 max and VCO2. Maximal power (W max) will be recorded. Patients will be encouraged during the test.
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Targeted therapy and severe fatigue (FSS)Other 1 intervention
Group B: Targeted therapy and mild fatigue (FSS <4)Other 1 intervention
Trial outcomes
Primary outcomes
1
Oxygen consumption capacity
Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)
Time frame
At inclusionSponsors and contacts
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Source ClinicalTrials.gov