Spondyloarthritis, AxialFamuspaNCT03940911
Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis
A study testing Measurement of aerobic exercise on cycloergometer in people with Spondyloarthritis, Axial and Fatigue, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis, Axial, Fatigue, Exercise Capacity
- What is being tested?
- Measurement of aerobic exercise on cycloergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2025to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin, 67000
Alain MEYER, MD, +33 3 88 11 67 68, alain.meyer1@chru-strasbourg.fr
About this study
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.
Read more
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.
Read the detailed description
This work will:
- Study for the first time the implication of the objective skeletal muscular impact in fatigue during SA.
- Better characterize the skeletal muscle impact of SA;
- Characterize the evolution of the fatigue and the muscular impact under targeted therapy
- Conditions
- Spondyloarthritis, Axial, Fatigue, Exercise Capacity
- Being tested
- Measurement of aerobic exercise on cycloergometer
- Keywords
- Axial spondylarthritis, Fatigue, Targeted therapy, Exercise capacity, Sarcopenia
- Medical subject headings
- Axial Spondyloarthritis, Fatigue, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of aerobic exercise on cycloergometerOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Measurement of aerobic exercise on cycloergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption capacity
Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start13 Nov 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondyloarthritis, AxialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940911
- Sponsor's protocol ID
- 7439
- Acronym
- Famuspa
- Status last verified
- Mar 2026
- First submitted
- 6 May 2019
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No