Structural Neuroplasticity Associated With Aerobic Treadmill Training in Geriatric Chronic Stroke Survivors
Primary Purpose
Stroke, Hemiparesis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
treadmill exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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)
(e) 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.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Treadmill training group (TAEX)
Attention control group (CON)
Outcomes
Primary Outcome Measures
aerobic capacity (peak VO2)
gait velocity
Secondary Outcome Measures
cortical thickness (MRI)
grey matter density (VBM-MRI)
cerebrovascular reserve capacity (ASL-MRI)
Full Information
NCT ID
NCT00614224
First Posted
January 31, 2008
Last Updated
May 27, 2015
Sponsor
Andreas R Luft
Collaborators
Robert Bosch Medical Center, Max-Planck-Institute Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00614224
Brief Title
Structural Neuroplasticity Associated With Aerobic Treadmill Training in Geriatric Chronic Stroke Survivors
Official Title
Structural Neuroplasticity Associated With Aerobic Treadmill Training in Geriatric Chronic Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andreas R Luft
Collaborators
Robert Bosch Medical Center, Max-Planck-Institute Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Treadmill training group (TAEX)
Arm Title
B
Arm Type
Active Comparator
Arm Description
Attention control group (CON)
Intervention Type
Behavioral
Intervention Name(s)
treadmill exercise training
Intervention Description
3 months (3 times/week) progressive graded aerobic treadmill training with a duration of 10-45 min per training session
Primary Outcome Measure Information:
Title
aerobic capacity (peak VO2)
Time Frame
Baseline (timepoint 0) and after training (3 months)
Title
gait velocity
Time Frame
Baseline (timepoint 0) and after training (3 months)
Secondary Outcome Measure Information:
Title
cortical thickness (MRI)
Time Frame
Baseline (timepoint 0) and after training (3 months)
Title
grey matter density (VBM-MRI)
Time Frame
Baseline (timepoint 0) and after training (3 months)
Title
cerebrovascular reserve capacity (ASL-MRI)
Time Frame
Baseline (timepoint 0) and after training (3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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)
(e) 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.)
12. IPD Sharing Statement
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Structural Neuroplasticity Associated With Aerobic Treadmill Training in Geriatric Chronic Stroke Survivors
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