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Clinical Trials/NCT00376207
NCT00376207CompletedNot Applicable

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

Bispebjerg Hospital2 sites in 1 country200 target enrollmentStarted: January 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
2
Primary Endpoint
Association between PASE and HOMA

Study Overview

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.

Study Design

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

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • participated in the ExStroke Pilot trail

Exclusion Criteria

  • Diabetes Mellitus
  • Not able to give informed consent

Outcomes

Primary Outcomes

Association between PASE and HOMA

Association between PASE and IL-6

Secondary Outcomes

  • 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

Investigators

Sponsor Class
Other

Study Sites (2)

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