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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
Bispebjerg Hospital
About
Eligibility
Locations
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2006
Last Updated
October 16, 2007
Sponsor
Bispebjerg Hospital
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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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