Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses (Exercise)

February 20, 2012 updated by: Gerhard Jan Jungehuelsing
The purpose of this trial is to study the improvement of cerebral hemodynamics in high risk stroke patients with impaired Cerebrovascular Reserve (CVR) due to high grade stenosis of the internal carotid (ICA) or middle cerebral artery (MCA) by Intense Aerobic Exercise (IAEx).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary objective: Intense aerobic exercise (24/8 weeks) improves CVR > 20% measured by Transcranial Doppler (TCD) in patients with hemodynamic relevant intra- or extracranial stenoses by enhanced cerebral arterio- and angiogenesis.

Secondary objectives:

Intense aerobic exercise (24/8 weeks) leads to:

  • an increase of Endothelial progenitor cell counts (EPCs)
  • qualitative and quantitative changes of endothelial markers and cytokines representing the inflammatory activity of atherosclerosis and neovascularisation
  • an improvement in cognitive performance and quality of life (QoL)
  • changes of the mean vessel size and of cerebral perfusion

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • high-grade stenosis of the intra- or extracranial ICA or the MCA with ipsilateral impairment of the CVR capacity measured by TCD

Exclusion Criteria:

  • continuous physical activity ≥ 60 min/week within the last 3 months
  • cerebral bleeding or ischaemic stroke < 3 months
  • contraindications for spiro-ergometry, IAEx, or MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Sedentary
patients who train after an 8 week observational period
Active Comparator: patients who train immediately after enrollment
Behavioral: Intense aerobic exercise
3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of cerebrovascular reserve capacity
Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Endothelial Progenitor Cells, cyto- and chemokines
Time Frame: after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Neuropsychological Testing/ Quality of life
Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerhard Jan Jungehuelsing

Collaborators

German Federal Ministry of Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCBF-Exercise
  • EA4/106/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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