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Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00376207
First Posted: September 14, 2006
Last Update Posted: October 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bispebjerg Hospital
  Purpose

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 Intervention
Cerebral Infarction Behavioral: Physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Association between PASE and HOMA
  • Association between PASE and IL-6

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: January 2006
Study Completion Date: August 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participated in the ExStroke Pilot trail

Exclusion Criteria:

  • Diabetes Mellitus
  • Not able to give informed consent
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Lars-Henrik Krarup, MD Bispebjerg Hospital
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00376207     History of Changes
Other Study ID Numbers: LK-0102200601
First Submitted: September 13, 2006
First Posted: September 14, 2006
Last Update Posted: October 17, 2007
Last Verified: October 2007

Keywords provided by Bispebjerg Hospital:
Cerebral infarct
physical exercise
insulin sensitivity
low grade chronic inflammation
intervention
HOMA
PASE

Additional relevant MeSH terms:
Infarction
Insulin Resistance
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs