Fatigue and muscle health in severe axial spondyloarthritis
Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis
This project will test whether reduced muscle strength, mass, and exercise capacity explain severe fatigue in adults with axial spondyloarthritis who are just starting targeted therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg, Bas-Rhin) |
| Trial ID | NCT03940911 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults with axial spondyloarthritis who have severe fatigue and are naïve to targeted therapy or have started it within 15 days. Participants undergo objective skeletal muscle testing including cycloergometer aerobic exercise testing, strength and muscle mass measurements, and standardized fatigue questionnaires at baseline and during follow-up after initiating targeted therapy. Investigators will compare subjective fatigue severity with objective muscle measures to define their relationship and how both change after starting targeted therapy. The aim is to better characterize muscle involvement in axial SpA and how targeted treatments influence fatigue and exercise capacity.
Who should consider this trial
Good fit: Adults (≥18) who meet ASAS criteria for axial spondyloarthritis, have severe fatigue, are naïve to targeted therapy or started it ≤15 days before inclusion, can consent, and can follow the protocol in French at the Strasbourg center.
Not a fit: Patients already on targeted therapy for more than 15 days, with other systemic inflammatory diseases (aside from ocular or cutaneous involvement), associated fibromyalgia, recent systemic corticosteroid use, contraindications to exercise or targeted therapy, inability to attend the Strasbourg site, or insufficient French language skills are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help tailor treatments or rehabilitation to reduce fatigue by targeting muscle loss and improving exercise capacity in people with axial SpA.
How similar studies have performed: While exercise capacity and sarcopenia have been studied in related disorders, the direct link between objective skeletal muscle impact and severe fatigue in axial spondyloarthritis has not previously been studied, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 * Subject in exclusion period defined by another clinical study or participating in a study likely to impact the results of the research
Where this trial is running
Strasbourg, Bas-Rhin
- Hôpitaux Universitaires de Strasbourg — Strasbourg, Bas-Rhin, France (Recruiting)
Study contacts
- Study coordinator: Alain MEYER, MD
- Email: alain.meyer1@chru-strasbourg.fr
- Phone: +33 3 88 11 67 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.