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Completed

NCT Number: NCT00376207

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

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.

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Key information

Conditions

Cerebral Infarction Behavior Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Glucose Metabolism Disorders Hyperinsulinism Infarction Insulin Resistance Ischemia Metabolic Diseases Motor Activity Necrosis Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participated in the ExStroke Pilot trail

Exclusion criteria

  • Diabetes Mellitus
  • Not able to give informed consent

Treatment and study plan

Physical exercise

Behavioral

Primary outcomes

  1. Association between PASE and HOMA

  2. Association between PASE and IL-6

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Sep 14, 2006
Registry last updated
Oct 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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