- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01478334
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Trondheim, Norge, 7006
- Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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. |
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Inflammatory markers in blood
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Endothelial function
Tidsram: 10 weeks
|
Flow mediated dilatation (FMD).
|
10 weeks
|
quality of life
Tidsram: 10 weeks
|
Questionnaire SF-36
|
10 weeks
|
HDL
Tidsram: 10 weeks
|
Standard biochemical analysis procedure at St.Olavs hospital
|
10 weeks
|
Total Cholesterol
Tidsram: 10 weeks
|
Standard biochemical analysis procedure at St.Olavs hospital
|
10 weeks
|
Blood glucose
Tidsram: 10 weeks
|
Standard biochemical analysis procedure at St.Olavs hospital
|
10 weeks
|
whole-genome gene expression in blood cells
Tidsram: 10 weeks
|
total RNA isolated from whole blood (Qiagen, Bioanalyzer, NanoDrop).
Gene expression analysis on HumanHT-12 v4 Expression BeadChip.
|
10 weeks
|
Samarbetspartners och utredare
Utredare
- Studierektor: Dorthe Stensvold
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RA-2011
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