Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity
Primary Purpose
Cerebral Infarction
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Infarction focused on measuring Cerebral infarct, physical exercise, insulin sensitivity, low grade chronic inflammation, intervention, HOMA, PASE
Eligibility Criteria
Inclusion Criteria:
- participated in the ExStroke Pilot trail
Exclusion Criteria:
- Diabetes Mellitus
- Not able to give informed consent
Sites / Locations
- Bispebjerg Hospital
Outcomes
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
Full Information
NCT ID
NCT00376207
First Posted
September 13, 2006
Last Updated
October 16, 2007
Sponsor
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00376207
Brief Title
Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
Cerebral infarct, physical exercise, insulin sensitivity, low grade chronic inflammation, intervention, HOMA, PASE
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise
Primary Outcome Measure Information:
Title
Association between PASE and HOMA
Title
Association between PASE and IL-6
Secondary Outcome Measure Information:
Title
IL-6 concentration is lower in the intervention group than control group.
Title
TNF-alfa and IL-6 is positively associated.
Title
IL-18 is associated to HOMA
Title
Correlation between PASE and HOMA in the intervention group vs. controls
Title
HOMA mean value in the 2 groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participated in the ExStroke Pilot trail
Exclusion Criteria:
Diabetes Mellitus
Not able to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Henrik Krarup, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
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Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity
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