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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis

Clinicaltrials.gov identifier NCT03940911

Recruitment Status Not yet recruiting

First Posted May 7, 2019

Last update posted May 13, 2019

Study Description

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.

  • Condition or Disease:Fatigue
    Spondylarthritis
    Exercise Capacity
  • Intervention/Treatment: Other: Measurement of aerobic exercise on cycloergometer
  • Phase: N/A
Detailed Description

This work will: 1. • To study for the first time the implication of the objective skeletal muscular impact in fatigue during SA. 2. • To better characterize the skeletal muscle impact of SA; 3. • To characterize the evolution of the fatigue and the muscular impact under anti-TNFα treatment and the predictive factors of response, 4. • To identify new therapeutic targets for these two complications of SA, which currently have no specific treatment.

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: September 2022
Arms and interventions
Arm Intervention/treatment
Other: anti-TNFα treatment and severe fatigue (FSS)
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 mesurement Needle muscle of the vastus lateralis (This act will be limited to patients in care at Strasbourg University Hospital n=30)
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.
Other: anti-TNFα treatment and with mild fatigue (FSS <4)
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 Needle muscle of the vastus lateralis (This act will be limited to patients in care at Strasbourg University Hospital n=30)
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.
Outcome Measures
  • Primary Outcome Measures: 1. Oxygen consumption capacity [ Time Frame: At inclusion ]
    Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

University Hospital, Strasbourg, France

More Information
  • Responsible Party: University Hospital, Strasbourg, France
  • ClinicalTrials.gov Identifier: NCT03940911 History of Changes
  • Other Study ID Numbers: 7439
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 13, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Strasbourg, France: Axial spondylarthritis
    tired
    Anti-TNF alpha
    exercises capacity
    sacoprnia
  • Additional relevant MeSH terms: Fatigue Spondylarthritis