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Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis (Famuspa)

Primary Purpose

Spondylarthritis, Fatigue, Exercise Capacity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Measurement of aerobic exercise on cycloergometer
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spondylarthritis focused on measuring Axial spondylarthritis, tired, Anti-TNF alpha, exercises capacity, sacoprnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    anti-TNFα treatment and severe fatigue (FSS)

    anti-TNFα treatment and with mild fatigue (FSS <4)

    Arm Description

    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)

    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)

    Outcomes

    Primary Outcome Measures

    Oxygen consumption capacity
    Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2019
    Last Updated
    May 10, 2019
    Sponsor
    University Hospital, Strasbourg, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03940911
    Brief Title
    Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis
    Acronym
    Famuspa
    Official Title
    Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 12, 2019 (Anticipated)
    Primary Completion Date
    December 12, 2019 (Anticipated)
    Study Completion Date
    September 12, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Strasbourg, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spondylarthritis, Fatigue, Exercise Capacity
    Keywords
    Axial spondylarthritis, tired, Anti-TNF alpha, exercises capacity, sacoprnia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    125 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    anti-TNFα treatment and severe fatigue (FSS)
    Arm Type
    Other
    Arm Description
    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)
    Arm Title
    anti-TNFα treatment and with mild fatigue (FSS <4)
    Arm Type
    Other
    Arm Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Measurement of aerobic exercise on cycloergometer
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Oxygen consumption capacity
    Description
    Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)
    Time Frame
    At inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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    Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis

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