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Clinical Trials/NCT03940911
NCT03940911
Recruiting
Not Applicable

Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

University Hospital, Strasbourg, France1 site in 1 country122 target enrollmentNovember 13, 2025

Overview

Phase
Not Applicable
Intervention
Measurement of aerobic exercise on cycloergometer
Conditions
Spondyloarthritis, Axial
Sponsor
University Hospital, Strasbourg, France
Enrollment
122
Locations
1
Primary Endpoint
Oxygen consumption capacity
Status
Recruiting
Last Updated
last month

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
November 13, 2025
End Date
December 1, 2029
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

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
  • Neuromuscular pathology
  • Insufficiency of organ (renal, hepatic pulmonary heart)
  • Sleep apnea

Arms & Interventions

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

Intervention: Measurement of aerobic exercise on cycloergometer

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

Intervention: Measurement of aerobic exercise on cycloergometer

Outcomes

Primary Outcomes

Oxygen consumption capacity

Time Frame: At inclusion

Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)

Study Sites (1)

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