Acute Effect of Resistance Training in Inflammatory Markers in Women With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401958
• Other study ID #: CEP UNIFESP -
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2015
• Last updated: May 16, 2016
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

ABSTRACT Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory, chronic and progressive disease that can lead to joint destruction and important functional disability. Chronic inflammation, with a substantial increase in the amount of pro-inflammatory cytokines in synovial joint, is one of the biggest challenges in controlling RA. Resistance exercise has been recognized for positively modulate inflammation in healthy subjects. Objective: To evaluate the effect of an acute bout of resistance exercise on serum concentrations of tumor necrosis factor alpha (TNF-α), interleukin 1 receptor antagonist(IL-1ra), interleukin 1 beta (IL-1β), C reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), and cartilage oligomeric matrix protein (COMP) in postmenopausal women with RA and women without the disease. Methods: 17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session. Serum glucose concentrations prior to exercise were also measured. The investigators used the Student's't test, the model of analysis of variance with repeated measures and Bonferroni method of multiple comparisons to analyze the data, being considered statistically significant levels of p <0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

*Rheumatoid Arthritis Group

Inclusion Criteria:

• Women classified acording to the American College of Rheumatology's criteria to rheumatoid arthritis

• Post menopausal women

• Stable medication three months before study

Exclusion Criteria:

• Women with rheumatoid arthritis with functional class IV, acording to ACR criteria

• Women engaged in some type of regular exercise program;

• Failure: heart, coronary, respiratory, renal and / or hepatic (uncompensated);

• Uncompensated systemic hypertension;

• Volunteers with other associated inflammatory diseases;

• Unable to perform the exercises.

• Control group We included in the control group of this study postmenopausal volunteers, without Rheumatoid Arthritis. Exclusion criteria were the same as those adopted for the participants of the Rheumatoid Arthritis Group

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Resistance training
17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in one (or more) of the inflammatory markers	TNF-alfa, IL1-beta, IL1-ra, PCR, IL10, IL6	30 minutes before training; 5 minutes before training; 5 minutes after training; 1 hour after training; 2 hours after training; 24 hours after training	No
Secondary	No change in inflammatory markers	TNF-alfa, IL1-beta, IL1-ra, PCR, IL10, IL6	30 minutes before training; 5 minutes before training; 5 minutes after training; 1 hour after training; 2 hours after training; 24 hours after training	No