Fatigue and Skeletal Muscle Impact in Severe Axial Spondylarthritis (Famuspa)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: anti-TNFα treatment and severe fatigue (FSS)
See bellow (section "Interventions") the full description for
|
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. |
|
Outro: anti-TNFα treatment and with mild fatigue (FSS <4)
See bellow (section "Interventions") the full description for
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Oxygen consumption capacity
Prazo: At inclusion
|
Maximum oxygen consumption capacity on cycloergometer during an incremental effort until exhaustion (VO2 max)
|
At inclusion
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 7439
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