Acute Response to Exercise in Patients With Rheumatoid Arthritis

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: Exercise

• Registration Number: NCT04927546
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-16
• Status Verified: 2021-08
• Study Start: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	Exercise	Healthy participants.
IL-6 blockade	Exercise	RA patients under pharmacological treatment with interleukin-6 blockade.
Anti-TNF-alpha	Exercise	RA patients under pharmacological treatment with anti-TNF-alpha.

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	1 hour post-exercise	Acute effect of exercise on insulin sensitivity assessed by the hyperinsulinemic euglycemic clamp.

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity-related molecular pathway (Western Blotting)	Baseline and 4 hours post-exercise	Insulin sensitivity-related molecular pathway will be assessed by Western Blotting.
Skeletal muscle glucose uptake	3 hours post-exercise	Positron emission tomography-magnetic resonance imaging (PET/MRI) will be performed to quantify skeletal muscle glucose uptake.
Insulin sensitivity-related molecular pathway (RT-PCR)	Baseline and 4 hours post-exercise	Insulin sensitivity-related molecular pathway will be assessed by Real-Time Polymerase Chain Reaction (RT-PCR).

Trial Locations

Locations (1)

Univsersity of Sao Paulo; 🇧🇷 Sao Paulo, Brazil