NCT00912561

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

2.5 years

First QC Date

June 2, 2009

Last Update Submit

February 20, 2012

Conditions

Stenosis

Keywords

chronic brain ischaemiastroke preventionexercisephysical trainingChronic, extra- or intracranial stenoses of brain supplying arteries

Outcome Measures

Primary Outcomes (1)

  • change of cerebrovascular reserve capacity

    immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up

Secondary Outcomes (2)

  • Endothelial Progenitor Cells, cyto- and chemokines

    after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up

  • Neuropsychological Testing/ Quality of life

    immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up

Study Arms (2)

Sedentary

NO INTERVENTION

patients who train after an 8 week observational period

patients who train immediately after enrollment

ACTIVE COMPARATOR

patients who train immediately after enrollment

Behavioral: Intense aerobic exercise

Interventions

Intense aerobic exerciseBEHAVIORAL

3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks

patients who train immediately after enrollment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin

Berlin, 12200, Germany

Location

MeSH Terms

Conditions

Constriction, PathologicMotor ActivityBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBehaviorOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

DE(1)