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

NCT02401958 | Completed Phase 4 DMC

• 1 other identifier: CEP UNIFESP -
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• No change in inflammatory markers

  30 minutes before training; 5 minutes before training; 5 minutes after training; 1 hour after training; 2 hours after training; 24 hours after training

Study Arms (2)

Rheumatoid Arthritis Group

EXPERIMENTAL

Resistance Training

Other: Resistance training

Healthy control Group

ACTIVE COMPARATOR

Resistance Training

Other: Resistance training

Interventions

Resistance training OTHER

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.

Healthy control Group; Rheumatoid Arthritis Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women classified acording to the American College of Rheumatology's criteria to rheumatoid arthritis
• Post menopausal women
• Stable medication three months before study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023900, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Resistance Training

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)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 30, 2015
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

BR (1)