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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
high intensity interval training
Control
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring High intensity exercise, cardiovascular risk factors

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise then control

Control then exercise

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Endothelial function
Flow mediated dilatation (FMD).
quality of life
Questionnaire SF-36
HDL
Standard biochemical analysis procedure at St.Olavs hospital
Total Cholesterol
Standard biochemical analysis procedure at St.Olavs hospital
Blood glucose
Standard biochemical analysis procedure at St.Olavs hospital
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.

Full Information

First Posted
September 7, 2011
Last Updated
May 28, 2015
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01478334
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
High intensity exercise, cardiovascular risk factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise then control
Arm Type
Experimental
Arm Title
Control then exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
high intensity interval training
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
Inflammatory markers in blood
Description
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)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Endothelial function
Description
Flow mediated dilatation (FMD).
Time Frame
10 weeks
Title
quality of life
Description
Questionnaire SF-36
Time Frame
10 weeks
Title
HDL
Description
Standard biochemical analysis procedure at St.Olavs hospital
Time Frame
10 weeks
Title
Total Cholesterol
Description
Standard biochemical analysis procedure at St.Olavs hospital
Time Frame
10 weeks
Title
Blood glucose
Description
Standard biochemical analysis procedure at St.Olavs hospital
Time Frame
10 weeks
Title
whole-genome gene expression in blood cells
Description
total RNA isolated from whole blood (Qiagen, Bioanalyzer, NanoDrop). Gene expression analysis on HumanHT-12 v4 Expression BeadChip.
Time Frame
10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorthe Stensvold
Official's Role
Study Director
Facility Information:
Facility Name
Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26013051
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.
Results Reference
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Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis

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