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

NCT ID: NCT01478334

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-05-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise then control

Group Type: EXPERIMENTAL

high intensity interval training

Intervention Type: 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 then exercise

Group Type: EXPERIMENTAL

Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorthe Stensvold

Role: STUDY_DIRECTOR

Locations

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

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 26013051 (View on PubMed)

Other Identifiers

RA-2011

Identifier Type: -

Identifier Source: org_study_id