Acute Response to Exercise in Patients With Rheumatoid Arthritis

University of Sao Paulo

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04927546

IL-6 blockade and exercise

Details and patient eligibility

About

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects the joints, causing pain, edema, physical disability and poor quality of life. In addition, RA patients are at increased risk of developing cardiovascular disease (CVD) and premature death. The most effective pharmacological treatment is the use of biological agents that inhibit the action of specific substances, such as interleukin 6 (IL-6) and tumor necrosis factors (TNF). Physical exercise is considered a first-line non-pharmacological treatment in RA, improving inflammatory and metabolic profile, functional capacity, fatigue and preventing the onset of CVD. There is evidence that IL-6, when secreted as a result of exercise, brings several benefits. However, there is no study investigating the interaction between biological IL-6 blocking agents and exercise on metabolic responses, such as insulin sensitivity and glucose uptake, in patients with RA. To answer this question, adult women diagnosed with RA and healthy controls will be recruited for an acute session of exercise. RA patients will be divided into 2 groups, according to the pharmacological treatment (tocilizumab or anti-TNF). The acute responses of insulin sensitivity after an acute session of exercise will be assessed by the hyperinsulinemic euglycemic clamp, and the molecular pathways will be assessed by muscle biopsy and gene and protein expression analysis. Positron emission tomography-magnetic resonance imaging (PET/MRI) will be performed to quantify skeletal muscle glucose uptake.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult women diagnosed with rheumatoid arthritis under pharmacological treatment, for at least 6 months, with a monoclonal antibody against the interleukin-6 receptor or TNF-alpha inhibitors;
• Stable dose of monoclonal antibody against the interleukin-6 receptor or TNF-alpha inhibitors in the previous 3 months;

Exclusion criteria

• Any physical limitation or disability that preclude exercise participation;
• Participation in a structured exercise program in the previous 12 months;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

IL-6 blockade

Experimental group

Description:

RA patients under pharmacological treatment with interleukin-6 blockade.

Treatment:

Behavioral: Exercise

Anti-TNF-alpha

Experimental group

Description:

RA patients under pharmacological treatment with anti-TNF-alpha.

Treatment:

Behavioral: Exercise

Healthy controls

Experimental group

Description:

Healthy participants.

Treatment:

Behavioral: Exercise