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

This study has been completed.
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00376207
First received: September 13, 2006
Last updated: October 16, 2007
Last verified: October 2007
  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 Blind
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00376207     History of Changes
Other Study ID Numbers: LK-0102200601
Study First Received: September 13, 2006
Last Updated: October 16, 2007
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Inflammation
Insulin Resistance
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 27, 2014