Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

Sponsor
University Hospital, Strasbourg, France
Study ID
NCT03940911
Status
Recruiting
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Conditions

  • Exercise Capacity
  • Fatigue
  • Spondyloarthritis, Axial

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Measurement of aerobic exercise on cycloergometer — OTHER
    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.

Study Details

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.

Key Dates

First listed
May 7, 2019
Start date
Nov 13, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
122 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Targeted therapy and severe fatigue (FSS)
    See bellow (section "Interventions") the full description for * Measurement of aerobic exercise on cycloergometer * Measurement of muscle mass by two-photon absorptiometry: specific study * Measurement of Isometric Muscle Strength * Blood sampling for measurement of cytokine levels in the blood * Measurement of sedentarity * Psychological impact * Fatigue measurement
  • Other: Targeted therapy and mild fatigue (FSS <4)
    See bellow (section "Interventions") the full description for * Measurement of aerobic exercise on cycloergometer * Measurement of muscle mass by two-photon absorptiometry: specific study * Measurement of Isometric Muscle Strength * Blood sampling for measurement of cytokine levels in the blood * Measurement of sedentarity * Psychological impact * Fatigue measurement

Primary Outcome Measure

Oxygen consumption capacity [ Time Frame: At inclusion ]

Central Contacts

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