Skip to content

Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03940911
Acronym
Famuspa
Enrollment
122
Registered
2019-05-07
Start date
2025-11-13
Completion date
2029-12-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Capacity, Fatigue, Spondyloarthritis, Axial

Keywords

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

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

Interventions

OTHERMeasurement 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.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygen consumption capacityAt inclusionMaximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)

Countries

France

Contacts

CONTACTAlain MEYER, MD
alain.meyer1@chru-strasbourg.fr+33 3 88 11 67 68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026