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

NCT00376207 | Completed

• 1 other identifier: LK-0102200601
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Infarction

Keywords

Cerebral infarct; physical exercise; insulin sensitivity; low grade chronic inflammation; intervention; HOMA; PASE

Outcome Measures

Primary Outcomes (2)

• Association between PASE and HOMA

• Association between PASE and IL-6

Secondary Outcomes (5)

• 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

Interventions

Physical exercise BEHAVIORAL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participated in the ExStroke Pilot trail

You may not qualify if:

• Diabetes Mellitus
• Not able to give informed consent

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Cerebral Infarction; Motor Activity; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lars-Henrik Krarup, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 14, 2006
• Study Start: January 1, 2006
• Study Completion: August 1, 2007
• Last Updated: October 17, 2007

Record last verified: 2007-10

Locations

DK (1)