Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity
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|ClinicalTrials.gov Identifier: NCT00376207|
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : October 17, 2007
Decreased insulin sensitivity is and independent risk factor for stroke despite glycemic control. It is known that physical exercise increases insulin sensitivity in healthy subjects. Wether stroke patients can increase insulin sensitivity via physical exercise is not known.
Chronic low-grade inflammation is associated with an increased risk of stroke. Physical exercise has shown to increase IL-6 directly after exercise in untrained subjects. When fitness is increased in each subject then the peak IL-6 concentration after exercise decreases and so does the basal level of IL-6. It is not known whether stroke patients can increase physical activity level to a degree where chronic inflammation are decreased.
This study is designed to evaluate if physical exercise after stroke will increases insulin sensitivity and reduce low-grade chronic inflammation.
Stroke patients have been randomized to intervention with physical exercise or control in the ExStroke pilot trial and followed for 2 years. Using the study population from the ExStroke pilot trail blood samples will be obtained at the last control. Insulin sensitivity can be measured from fasting glucose and insulin using the Homeostasis Model Assessment (HOMA). Interleukin-6, TNF-alfa and CRP is measured to estimate chronic inflammation.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Infarction||Behavioral: Physical exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||January 2006|
|Actual Study Completion Date :||August 2007|
- Association between PASE and HOMA
- Association between PASE and IL-6
- IL-6 concentration is lower in the intervention group than control group.
- TNF-alfa and IL-6 is positively associated.
- IL-18 is associated to HOMA
- Correlation between PASE and HOMA in the intervention group vs. controls
- HOMA mean value in the 2 groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376207
|Copenhagen, Denmark, 2400|
|Principal Investigator:||Lars-Henrik Krarup, MD||Bispebjerg Hospital|