Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

Not Applicable

Not yet recruiting

• Conditions: Exercise Capacity; Spondyloarthritis, Axial; Fatigue
• Interventions: Other: Measurement of aerobic exercise on cycloergometer

• Registration Number: NCT03940911
• Lead Sponsor: University Hospital, Strasbourg, France

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:

1. Study for the first time the implication of the objective skeletal muscular impact in fatigue during SA.

2. Better characterize the skeletal muscle impact of SA;

3. Characterize the evolution of the fatigue and the muscular impact under targeted therapy

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Study Start: 2025-06
• Primary Completion: 2029-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted therapy and severe fatigue (FSS)	Measurement of aerobic exercise on cycloergometer	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
Targeted therapy and mild fatigue (FSS <4)	Measurement of aerobic exercise on cycloergometer	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

Primary Outcome Measures

Name	Time	Method
Oxygen consumption capacity	At inclusion	Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)