Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis

Fatigue Clinical Trial

— Famuspa  

Official title:

Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03940911
• Other study ID #: 7439
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: September 12, 2022

Study information

• Verified date: May 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: September 12, 2022
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exercise Capacity
• Fatigue
• Spondylarthritis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen consumption capacity	Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)	At inclusion