Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: Control; Behavioral: high intensity interval training

• Registration Number: NCT01478334
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

The primary aim of the study is to investigate if 10 weeks of high intensity interval training improve inflammatory status in patients with rheumatoid arthritis.

Detailed Description

Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder that may affect many tissues and organs, but principally attacks synovial joints. Although the cause of rheumatoid arthritis is unknown, autoimmunity plays a role in both the chronicity and progression, and RA is considered as a systemic autoimmune disease.

Due to chronic inflammatory status, RA-patients are at higher risk of developing cardiovascular disease (CVD) compared to the general population. Accumulating evidence indicates that regular physical activity has beneficial effects on RA. The mechanisms behind exercise-induce improvements are none the less unclear and more research is needed to better understand the beneficial effects of exercise training in this patient group.

Recently, promising results from gene expression studies of blood cells have revealed unexplored fields of biomarker discovery and gene expression profiling of disease. Due to easy accessible and minimally invasive sample collection, gene expression profiling of whole blood might turn out to be a promising tool in molecular diagnostics and clinical medicine. To our knowledge, whole-genome transcriptional changes have not previously been studied in RA-patients undergoing a high-intensity exercise program.

Hypothesis: Ten weeks of high intensity interval training improves the inflammatory status, quality of life, and known risk factors for cardiovascular diseases.

In addition to measure traditionally inflammatory markers in the blood, whole genome analysis will be made.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-23
• Primary Completion: 2012-01
• Study Completion: 2012-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• Ability to exercise
• written consent

Exclusion Criteria

• Inability to exercise
• Known ischemic cardiovascular disease
• Severe pulmonary disease
• High activity level
• Pregnancy
• drug/alcohol abuse
• Unstable RA
• diagnosis before 2000

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control then exercise	Control	-
Exercise then control	high intensity interval training	-

Primary Outcome Measures

Name	Time	Method
Inflammatory markers in blood	10 weeks	C-reactive Protein (CRP), TNF-alfa, COMP, Pentraxin 3 using ELISA Whole-genome gene expression in blood cells using RNA(HumanHT-12 v4 Expression BeadChip)

Secondary Outcome Measures

Name	Time	Method
Blood glucose	10 weeks	Standard biochemical analysis procedure at St.Olavs hospital
quality of life	10 weeks	Questionnaire SF-36
Endothelial function	10 weeks	Flow mediated dilatation (FMD).
Total Cholesterol	10 weeks	Standard biochemical analysis procedure at St.Olavs hospital
whole-genome gene expression in blood cells	10 weeks	total RNA isolated from whole blood (Qiagen, Bioanalyzer, NanoDrop). Gene expression analysis on HumanHT-12 v4 Expression BeadChip.
HDL	10 weeks	Standard biochemical analysis procedure at St.Olavs hospital

Trial Locations

Locations (1)

Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,; 🇳🇴 Trondheim, Norway