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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01478334
First received: September 7, 2011
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Behavioral: high intensity interval training
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis - Improvements of Cardiovascular Risk Factors and Quality of Life

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Inflammatory markers in blood [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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:
  • Endothelial function [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Flow mediated dilatation (FMD).

  • quality of life [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Questionnaire SF-36

  • HDL [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Standard biochemical analysis procedure at St.Olavs hospital

  • Total Cholesterol [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Standard biochemical analysis procedure at St.Olavs hospital

  • Blood glucose [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Standard biochemical analysis procedure at St.Olavs hospital

  • whole-genome gene expression in blood cells [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    total RNA isolated from whole blood (Qiagen, Bioanalyzer, NanoDrop). Gene expression analysis on HumanHT-12 v4 Expression BeadChip.


Enrollment: 18
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise then control Behavioral: high intensity interval training

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.

Experimental: Control then exercise Behavioral: Control

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.


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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478334

Locations
Norway
Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Dorthe Stensvold
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01478334     History of Changes
Other Study ID Numbers: RA-2011
Study First Received: September 7, 2011
Last Updated: April 29, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
High intensity exercise
cardiovascular risk factors

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014