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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478334
• Other study ID #: RA-2011
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: May 28, 2015
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2015
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Sandstad J, Stensvold D, Hoff M, Nes BM, Arbo I, Bye A. The effects of high intensity interval training in women with rheumatic disease: a pilot study. Eur J Appl Physiol. 2015 Oct;115(10):2081-9. doi: 10.1007/s00421-015-3186-9. Epub 2015 May 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers in blood	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)	10 weeks	No
Secondary	Endothelial function	Flow mediated dilatation (FMD).	10 weeks	No
Secondary	quality of life	Questionnaire SF-36	10 weeks	No
Secondary	HDL	Standard biochemical analysis procedure at St.Olavs hospital	10 weeks	No
Secondary	Total Cholesterol	Standard biochemical analysis procedure at St.Olavs hospital	10 weeks	No
Secondary	Blood glucose	Standard biochemical analysis procedure at St.Olavs hospital	10 weeks	No
Secondary	whole-genome gene expression in blood cells	total RNA isolated from whole blood (Qiagen, Bioanalyzer, NanoDrop). Gene expression analysis on HumanHT-12 v4 Expression BeadChip.	10 weeks	No