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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

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

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

NCT ID

NCT03940911

First Posted

May 6, 2019

Last Updated

May 10, 2019

Sponsor

University Hospital, Strasbourg, France

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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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