StrokeNCT00614224
Structural Neuroplasticity Associated With Aerobic Treadmill Training in Geriatric Chronic Stroke Survivors
A study testing treadmill exercise training in people with Stroke and Hemiparesis, run by Andreas R Luft.
Trial summary
Aerobic treadmill exercise has been shown to improve walking, cardiovascular fitness and thereby risk factor profiles in chronic stroke patients (Macko et al., Stroke 2005). The proposed project is a randomized controlled trial in geriatric stroke patients with chronic disabilities to investigate potential mechanisms… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- treadmill exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Apr 2010
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women and men aged > 60 years
- first ever ischemic stroke at least prior 6 months
- all conventional inpatient and outpatient physical therapy completed
- residual hemiparetic gait disturbance adequate language and neurocognitive function to participate in exercise training and testing
Who cannot join
- already performing > 20 minutes aerobic exercise 3 X/ week
- Alcohol consumption >2 oz liquor, or 2x 4oz glasses of wine, or 2x 12 oz cans of beer per day.
- Cardiac history of
- unstable angina
- recent (< 3 months) myocardial infarction
- congestive heart failure (NYHA category II)
Show all 20Show fewer
- hemodynamically significant valvular dysfunction.
- Medical History:
- recent hospitalization (<3 months) for severe medical disease
- symptomatic peripheral arterial occlusive disease
- orthopedic or chronic pain conditions restricting exercise
- pulmonary or renal failure
- active cancer
- poorly controlled hypertension (>160/100) or diabetes mellitis (fasting glucose>180 mg/dl, HbA1C >10%)
- Neurological history of
- dementia
- receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2 point commands
- cognitive deficits (other than dementia and aphasia, as above)
- non-stroke neuromuscular disorder restricting exercise (eg Parkinson's Syndrome) (f) untreated major depression
- exclusion criteria for MRI scanning (metal implants (e.g. pacemaker), claustrophobia, etc.)
About this study
Aerobic treadmill exercise has been shown to improve walking, cardiovascular fitness and thereby risk factor profiles in chronic stroke patients (Macko et al., Stroke 2005). The proposed project is a randomized controlled trial in geriatric stroke patients with chronic disabilities to investigate potential mechanisms of treadmill therapy. The hypothesis is tested that 3-months of aerobic treadmill exercise induces structural brain plasticity and reorganization. The outcome measures are walking ability, gait pattern, cardiovascular fitness and brain morphology. This study will elucidate fundamental mechanisms of brain adaptations linked to task-repetitive aerobic lower extremity exercise. These mechanisms will not only lead to a better understanding but may also help to identify predictors of treatment response.
40 patients aged over 60 years with lower extremity paresis after a first-ever clinical stroke longer than 6 months prior to study inclusion will be recruited from: 1) The Geriatric Rehabilitation Clinic at the Robert-Bosch Hospital in Stuttgart 2) the Dept of Neurology, University Hospital in Tübingen. Subjects will be randomized to 3 months progressive graded aerobic treadmill exercise training (TAEX; 3 times/week, duration 10-45 min) or an attention control group (CON). Because we expect that localization and size of stroke affect therapy outcomes, stratified randomization will be used to balance entry into groups.
Read more
We hypothesize that 3 months of treadmill gait training but not conventional care leads to improvements of cardiovascular fitness and gait and to brain reorganization (structural plasticity) in regions in which functional adaptations have been demonstrated using fMRI in previous studies. The specific aims are:
- To assess reorganization by comparing cortical thickness, cortical density and fiber tract morphology before (time point 0), and after therapy (3 months) using T1-weighted 3D-MPRAGE images, voxel based morphometry and diffusion tensor imaging.
- To correlate brain reorganization with improvements in walking velocity, and analysis of gait patterns (parameters, swing time, stance time, gait symmetry).
- To correlate brain reorganization with location and size of the index stroke lesion and of diffuse white matter damage (subcortical vascular encephalopathy). Lesion and white matter damage will be evaluated based on T2-weighted FLAIR sequences.
- Conditions
- Stroke, Hemiparesis
- Being tested
- treadmill exercise training
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill exercise trainingBehavioural
3 months (3 times/week) progressive graded aerobic treadmill training with a duration of 10-45 min per training session
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Treadmill training group (TAEX) Receives: Behavioral: treadmill exercise training |
| B | Active comparator | Attention control group (CON) Receives: Behavioral: treadmill exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
aerobic capacity (peak VO2)
Measured: Baseline (timepoint 0) and after training (3 months)
gait velocity
Measured: Baseline (timepoint 0) and after training (3 months)
Secondary outcomes (3)
cortical thickness (MRI)
Measured: Baseline (timepoint 0) and after training (3 months)
grey matter density (VBM-MRI)
Measured: Baseline (timepoint 0) and after training (3 months)
cerebrovascular reserve capacity (ASL-MRI)
Measured: Baseline (timepoint 0) and after training (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreas R Luft
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Medical Center, Max-Planck-Institute Tuebingen
- Responsible party
- Sponsor-investigator, Andreas R Luft, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614224
- Sponsor's protocol ID
- BOSCH-TAEX-001
- Status last verified
- Jan 2008
- First submitted
- 31 Jan 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Neuroplasticity Associated With Aerobic Treadmill Training in Geriatric Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT00614224
- Acronym / sponsor ID
- BOSCH-TAEX-001
- Conditions
- Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Andreas R LuftUniversity, hospital or other
- Collaborators
- Robert Bosch Medical Center, Max-Planck-Institute Tuebingen
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Feb 2008 (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.
Aerobic treadmill exercise has been shown to improve walking, cardiovascular fitness and thereby risk factor profiles in chronic stroke patients (Macko et al., Stroke 2005). The proposed project is a randomized controlled trial in geriatric stroke patients with chronic disabilities to investigate potential mechanisms of treadmill therapy. The hypothesis is tested that 3-months of aerobic treadmill exercise induces structural brain plasticity and reorganization. The outcome measures are walking ability, gait pattern, cardiovascular fitness and brain morphology. This study will elucidate fundamental mechanisms of brain adaptations linked to task-repetitive aerobic lower extremity exercise. These mechanisms will not only lead to a better understanding but may also help to identify predictors of treatment response.
40 patients aged over 60 years with lower extremity paresis after a first-ever clinical stroke longer than 6 months prior to study inclusion will be recruited from: 1) The Geriatric Rehabilitation Clinic at the Robert-Bosch Hospital in Stuttgart 2) the Dept of Neurology, University Hospital in Tübingen. Subjects will be randomized to 3 months progressive graded aerobic treadmill exercise training (TAEX; 3 times/week, duration 10-45 min) or an attention control group (CON). Because we expect that localization and size of stroke affect therapy outcomes, stratified randomization will be used to balance entry into groups.
We hypothesize that 3 months of treadmill gait training but not conventional care leads to improvements of cardiovascular fitness and gait and to brain reorganization (structural plasticity) in regions in which functional adaptations have been demonstrated using fMRI in previous studies. The specific aims are:
- To assess reorganization by comparing cortical thickness, cortical density and fiber tract morphology before (time point 0), and after therapy (3 months) using T1-weighted 3D-MPRAGE images, voxel based morphometry and diffusion tensor imaging.
- To correlate brain reorganization with improvements in walking velocity, and analysis of gait patterns (parameters, swing time, stance time, gait symmetry).
- To correlate brain reorganization with location and size of the index stroke lesion and of diffuse white matter damage (subcortical vascular encephalopathy). Lesion and white matter damage will be evaluated based on T2-weighted FLAIR sequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: treadmill exercise trainingTreadmill training group (TAEX) |
| B | Active comparator | Behavioral: treadmill exercise trainingAttention control group (CON) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women and men aged > 60 years
- first ever ischemic stroke at least prior 6 months
- all conventional inpatient and outpatient physical therapy completed
- residual hemiparetic gait disturbance adequate language and neurocognitive function to participate in exercise training and testing
Key exclusion criteria (20 listed)
- already performing > 20 minutes aerobic exercise 3 X/ week
- Alcohol consumption >2 oz liquor, or 2x 4oz glasses of wine, or 2x 12 oz cans of beer per day.
- Cardiac history of
- Medical History:
- Neurological history of
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 |
|---|---|---|
| treadmill exercise training3 months (3 times/week) progressive graded aerobic treadmill training with a duration of 10-45 min per training session | Behavioural | A, B |
Primary outcome
aerobic capacity (peak VO2)
Time frame: Baseline (timepoint 0) and after training (3 months)
gait velocity
Time frame: Baseline (timepoint 0) and after training (3 months)
3 secondary outcomes
cortical thickness (MRI)
Time frame: Baseline (timepoint 0) and after training (3 months)
grey matter density (VBM-MRI)
Time frame: Baseline (timepoint 0) and after training (3 months)
cerebrovascular reserve capacity (ASL-MRI)
Time frame: Baseline (timepoint 0) and after training (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing treadmill exercise training in people with Stroke and Hemiparesis, run by Andreas R Luft.
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 4 inclusion and 20 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: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
aerobic capacity (peak VO2) (time frame: Baseline (timepoint 0) and after training (3 months)). The study lists 2 primary outcomes in all. 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 28 May 2015.