NCT03940911

Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Spondyloarthritis, Axial
• Fatigue
• Exercise Capacity

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2025-11-13
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2019-05-07
• Last updated: 2026-03-12

Locations

1 site across 1 country: France