Clinical trial NCT01478334: Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis
Official title: Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis - Improvements of Cardiovascular Risk Factors and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: High intensity exercise
cardiovascular risk factors
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 18
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inflammatory markers in blood
timeFrame: 10 weeks
Secondary outcomes:
measure: Endothelial function
timeFrame: 10 weeks
measure: quality of life
timeFrame: 10 weeks
measure: HDL
timeFrame: 10 weeks
measure: Total Cholesterol
timeFrame: 10 weeks
measure: Blood glucose
timeFrame: 10 weeks
measure: whole-genome gene expression in blood cells
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
Study officials:
name: Dorthe Stensvold
role: STUDY_DIRECTOR
References:
citation: 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.