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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
Sponsor:
Information provided by:
Bispebjerg Hospital

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Study Start Date : January 2006
Actual Study Completion Date : August 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Association between PASE and HOMA
  2. Association between PASE and IL-6

Secondary Outcome Measures :
  1. IL-6 concentration is lower in the intervention group than control group.
  2. TNF-alfa and IL-6 is positively associated.
  3. IL-18 is associated to HOMA
  4. Correlation between PASE and HOMA in the intervention group vs. controls
  5. HOMA mean value in the 2 groups

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00376207     History of Changes
Other Study ID Numbers: LK-0102200601
First Posted: September 14, 2006    Key Record Dates
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