StenosisExerciseNCT00912561
Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
A study testing Intense aerobic exercise in people with Stenosis, run by Gerhard Jan Jungehuelsing at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stenosis
- What is being tested?
- Intense aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high-grade stenosis of the intra- or extracranial ICA or the MCA with ipsilateral impairment of the CVR capacity measured by TCD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin
Berlin, 12200
About this study
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).
Read the 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
- Conditions
- Stenosis
- Being tested
- Intense aerobic exercise
- Keywords
- chronic brain ischaemia, stroke prevention, exercise, physical training, Chronic, extra- or intracranial stenoses of brain supplying arteries
- Medical subject headings
- Constriction, Pathologic, Motor Activity, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense aerobic exerciseBehavioural
3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intense aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of cerebrovascular reserve capacity
Measured: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Secondary outcomes (2)
Endothelial Progenitor Cells, cyto- and chemokines
Measured: after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Neuropsychological Testing/ Quality of life
Measured: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2012 (estimated)
Why it stopped: slow recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gerhard Jan Jungehuelsing
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor-investigator, Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912561
- Sponsor's protocol ID
- CCBF-Exercise
- Other IDs
- EA4/106/08
- Acronym
- Exercise
- Status last verified
- Feb 2012
- First submitted
- 2 Jun 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
- ClinicalTrials.gov ID
- NCT00912561
- Acronym / sponsor ID
- Exercise / CCBF-Exercise
- Conditions
- Stenosis
- Keywords
- chronic brain ischaemia, stroke prevention, exercise, physical training, Chronic, extra- or intracranial stenoses of brain supplying arteries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gerhard Jan JungehuelsingUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary | No intervention | –patients who train after an 8 week observational period |
| patients who train immediately after enrollment | Active comparator | Behavioral: Intense aerobic exercisepatients who train immediately after enrollment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high-grade stenosis of the intra- or extracranial ICA or the MCA with ipsilateral impairment of the CVR capacity measured by TCD
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intense aerobic exercise3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks | Behavioural | patients who train immediately after enrollment |
Primary outcome
change of cerebrovascular reserve capacity
Time frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
2 secondary outcomes
Endothelial Progenitor Cells, cyto- and chemokines
Time frame: 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
Results and safety
The study was stopped early (reason given: slow recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intense aerobic exercise in people with Stenosis, run by Gerhard Jan Jungehuelsing at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of cerebrovascular reserve capacity (time frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.