Acute Response to Exercise in Patients With Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

RA patients will be divided into 2 groups, according to the pharmacological treatment (tocilizumab or anti-TNF). A third group will be composed by healthy controls. 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IL-6 blockade

RA patients under pharmacological treatment with interleukin-6 blockade.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Thirty minutes of aerobic exercise in a treadmill.

Anti-TNF-alpha

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Thirty minutes of aerobic exercise in a treadmill.

Healthy controls

Healthy participants.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Thirty minutes of aerobic exercise in a treadmill.

Interventions

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Exercise

Thirty minutes of aerobic exercise in a treadmill.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes