Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

NCT03940911 | Recruiting

• 1 other identifier: 7439
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthritis, Axial; Fatigue; Exercise Capacity

Keywords

Axial spondylarthritis; Fatigue; Targeted therapy; Exercise capacity; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Oxygen consumption capacity

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

  At inclusion

Study Arms (2)

Targeted therapy and severe fatigue (FSS)

OTHER

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: Measurement of aerobic exercise on cycloergometer

Targeted therapy and mild fatigue (FSS <4)

OTHER

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: Measurement of aerobic exercise on cycloergometer

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.

Targeted therapy and mild fatigue (FSS <4); Targeted therapy and severe fatigue (FSS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Axial SA according to the ASAS criteria;
• Targeted therapy naïve patients
• Indication to start a targeted therapy;
• ≥ 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.

You may not qualify if:

• 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
• COPD
• Neuromuscular pathology
• Insufficiency of organ (renal, hepatic pulmonary heart)
• Sleep apnea
• Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
• Subject under the protection of justice
• Subject under guardianship or curatorship
• Breastfeeding
• Pregnancy

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas-Rhin, 67000, France

RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis; Fatigue; Sarcopenia

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Central Study Contacts

Alain MEYER, MD

CONTACT

+33 3 88 11 67 68; alain.meyer1@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 7, 2019
• Study Start: November 13, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)