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Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis (Famuspa)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spondylarthritis Fatigue Exercise Capacity | Other: Measurement of aerobic exercise on cycloergometer | Not Applicable |
This work will:
- • To study for the first time the implication of the objective skeletal muscular impact in fatigue during SA.
- • To better characterize the skeletal muscle impact of SA;
- • To characterize the evolution of the fatigue and the muscular impact under anti-TNFα treatment and the predictive factors of response,
- • To identify new therapeutic targets for these two complications of SA, which currently have no specific treatment.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 125 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis |
| Estimated Study Start Date : | September 12, 2019 |
| Estimated Primary Completion Date : | December 12, 2019 |
| Estimated Study Completion Date : | September 12, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
anti-TNFα treatment and severe fatigue (FSS)
See bellow (section "Interventions") the full description for
|
Other: Measurement 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. |
|
anti-TNFα treatment and with mild fatigue (FSS <4)
See bellow (section "Interventions") the full description for
|
Other: Measurement 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. |
- Oxygen consumption capacity [ Time Frame: At inclusion ]Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
-- Axial SA according to the ASAS criteria;
- Indication to start a biotherapy;
- ≥ 18 years old, no upper age limit;
- Subject affiliated to a social health insurance reimbursement;
- Subject having signed a dated and informed consent;
- Woman in childbearing age: negative beta-HCG test and effective contraception;
- Sufficient understanding of French to follow the protocol.
Exclusion criteria:
- Biologic treatments (ongoing or or taken during the 6 months preceding the study),
- Associated extramuscular inflammatory disease (s) (excluding ocular and cutaneous involvement) eg chronic inflammatory bowel disease
- Contraindication to the use of a biologic
- 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
- Corticosteroids in the 15
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 6, 2019 | ||||
| First Posted Date ICMJE | May 7, 2019 | ||||
| Last Update Posted Date | May 13, 2019 | ||||
| Estimated Study Start Date ICMJE | September 12, 2019 | ||||
| Estimated Primary Completion Date | December 12, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Oxygen consumption capacity [ Time Frame: At inclusion ] Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis | ||||
| Official Title ICMJE | Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis | ||||
| 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. |
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| Detailed Description |
This work will:
|
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Other: Measurement 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. |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
125 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 12, 2022 | ||||
| Estimated Primary Completion Date | December 12, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion criteria: -- Axial SA according to the ASAS criteria;
Exclusion criteria:
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | |||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03940911 | ||||
| Other Study ID Numbers ICMJE | 7439 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | University Hospital, Strasbourg, France | ||||
| Study Sponsor ICMJE | University Hospital, Strasbourg, France | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | University Hospital, Strasbourg, France | ||||
| Verification Date | May 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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