Acute Effect of Resistance Training in Inflammatory Markers in Women With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
*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
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rheumatoid Arthritis Group
Healthy control Group
Arm Description
Resistance Training
Resistance Training
Outcomes
Primary Outcome Measures
Change in one (or more) of the inflammatory markers
TNF-alfa, IL1-beta, IL1-ra, PCR, IL10, IL6
Secondary Outcome Measures
No change in inflammatory markers
TNF-alfa, IL1-beta, IL1-ra, PCR, IL10, IL6
Full Information
NCT ID
NCT02401958
First Posted
March 19, 2015
Last Updated
May 16, 2016
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02401958
Brief Title
Acute Effect of Resistance Training in Inflammatory Markers in Women With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rheumatoid Arthritis Group
Arm Type
Experimental
Arm Description
Resistance Training
Arm Title
Healthy control Group
Arm Type
Active Comparator
Arm Description
Resistance Training
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in one (or more) of the inflammatory markers
Description
TNF-alfa, IL1-beta, IL1-ra, PCR, IL10, IL6
Time Frame
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 Outcome Measure Information:
Title
No change in inflammatory markers
Description
TNF-alfa, IL1-beta, IL1-ra, PCR, IL10, IL6
Time Frame
30 minutes before training; 5 minutes before training; 5 minutes after training; 1 hour after training; 2 hours after training; 24 hours after training
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
*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
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023900
Country
Brazil
12. IPD Sharing Statement
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Acute Effect of Resistance Training in Inflammatory Markers in Women With Rheumatoid Arthritis
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