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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT03940911
- Acronym / sponsor ID
- Famuspa / 7439
- Conditions
- Spondyloarthritis, Axial, Fatigue, Exercise Capacity
- Keywords
- Axial spondylarthritis, Fatigue, Targeted therapy, Exercise capacity, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted therapy and severe fatigue (FSS) | Other | Other: Measurement of aerobic exercise on cycloergometerSee 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 |
| Targeted therapy and mild fatigue (FSS <4) | Other | Other: Measurement of aerobic exercise on cycloergometerSee 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of aerobic exercise on cycloergometerThe 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. | Other | Targeted therapy and mild fatigue (FSS <4), Targeted therapy and severe fatigue (FSS) |
Primary outcome
Oxygen consumption capacity
Time frame: At inclusion
Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain MEYER, MD (+33 3 88 11 67 68, alain.meyer1@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption capacity (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.