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Completed

NCT Number: NCT01478334

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,

Trondheim, 7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Interval Training

Behavioral

First 10 week of high intensity interval training, twice a week. The interval training session consists of 10 minutes warm up at 70 percent of maximal heart rate and continues with 4 times 4 minutes of high intensity intervals at 90 to 95 percent of maximal heart rate separated by 3 minutes of active brakes in between at 70 percent of maximal heart rate. Training will be performed by cycling. Training intensity will be supervised through the use of polar puls monitors and the BORG scale of subjective perceived exhaustion.

Second 10 weeks participants are instructed not to change their dietary patterns or physical activity levels during the study period.

Control

Behavioral

First 10 weeks participants are instructed not to change their dietary patterns or physical activity levels, and to continue their habitually lifestyle.

Second 10 week of high intensity interval training, twice a week. The interval training session consists of 10 minutes warm up at 70 percent of maximal heart rate and continues with 4 times 4 minutes of high intensity intervals at 90 to 95 percent of maximal heart rate separated by 3 minutes of active brakes in between at 70 percent of maximal heart rate. Training will be performed by cycling. Training intensity will be supervised through the use of polar puls monitors and the BORG scale of subjective perceived exhaustion.

Primary outcomes

  1. Inflammatory markers in blood

    Time frame: 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 outcomes

  1. Endothelial function

    Time frame: 10 weeks

    Flow mediated dilatation (FMD).

  2. quality of life

    Time frame: 10 weeks

    Questionnaire SF-36

  3. HDL

    Time frame: 10 weeks

    Standard biochemical analysis procedure at St.Olavs hospital

  4. Total Cholesterol

    Time frame: 10 weeks

    Standard biochemical analysis procedure at St.Olavs hospital

  5. Blood glucose

    Time frame: 10 weeks

    Standard biochemical analysis procedure at St.Olavs hospital

  6. whole-genome gene expression in blood cells

    Time frame: 10 weeks

    total RNA isolated from whole blood (Qiagen, Bioanalyzer, NanoDrop). Gene expression analysis on HumanHT-12 v4 Expression BeadChip.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis - Improvements of Cardiovascular Risk Factors and Quality of Life

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 23, 2011
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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