Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis
Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis - Improvements of Cardiovascular Risk Factors and Quality of Life
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Trondheim、ノルウェー、7006
- Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Exercise then control
|
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. |
|
実験的：Control then exercise
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inflammatory markers in blood
時間枠：10 weeks
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Endothelial function
時間枠：10 weeks
|
Flow mediated dilatation (FMD).
|
10 weeks
|
|
quality of life
時間枠：10 weeks
|
Questionnaire SF-36
|
10 weeks
|
|
HDL
時間枠：10 weeks
|
Standard biochemical analysis procedure at St.Olavs hospital
|
10 weeks
|
|
Total Cholesterol
時間枠：10 weeks
|
Standard biochemical analysis procedure at St.Olavs hospital
|
10 weeks
|
|
Blood glucose
時間枠：10 weeks
|
Standard biochemical analysis procedure at St.Olavs hospital
|
10 weeks
|
|
whole-genome gene expression in blood cells
時間枠：10 weeks
|
total RNA isolated from whole blood (Qiagen, Bioanalyzer, NanoDrop).
Gene expression analysis on HumanHT-12 v4 Expression BeadChip.
|
10 weeks
|
協力者と研究者
捜査官
- スタディディレクター：Dorthe Stensvold
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。