Acute Response to Exercise in Patients With Rheumatoid Arthritis

NCT04927546 | Unknown

• 1 other identifier: IL-6 blockade and exercise
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Acute effect of exercise on insulin sensitivity assessed by the hyperinsulinemic euglycemic clamp.

  1 hour post-exercise

Secondary Outcomes (3)

• Insulin sensitivity-related molecular pathway (Western Blotting)

  Baseline and 4 hours post-exercise

• Insulin sensitivity-related molecular pathway (RT-PCR)

  Baseline and 4 hours post-exercise

• Skeletal muscle glucose uptake

  3 hours post-exercise

Study Arms (3)

IL-6 blockade

EXPERIMENTAL

RA patients under pharmacological treatment with interleukin-6 blockade.

Behavioral: Exercise

Anti-TNF-alpha

EXPERIMENTAL

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

Behavioral: Exercise

Healthy controls

EXPERIMENTAL

Healthy participants.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Thirty minutes of aerobic exercise in a treadmill.

Anti-TNF-alpha; Healthy controls; IL-6 blockade

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Univsersity of Sao Paulo

São Paulo, 05508-030, Brazil

RECRUITING

Related Publications (1)

• Casale AR, Lemes IR, Smaira FI, Astley C, Oliveira-Junior G, de Sa Pinto AL, de Medeiros-Ribeiro AC, Godoy-Santos AL, Lima M, Carneiro CG, Buchpiguel CA, Dantas WS, Axelrod CL, Javvadi P, Ghosh S, Kirwan JP, Roschel H, Gualano B. Interleukin-6 blockade does not impair exercise-induced glucose uptake and insulin sensitivity in rheumatoid arthritis. Am J Physiol Endocrinol Metab. 2025 Dec 1;329(6):E849-E860. doi: 10.1152/ajpendo.00348.2025. Epub 2025 Oct 17.

  PMID: 41106846 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 16, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)