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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
Andreas R Luft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    1. unstable angina
    2. recent (< 3 months) myocardial infarction
    3. congestive heart failure (NYHA category II)
    4. hemodynamically significant valvular dysfunction.
  • Medical History:

    1. recent hospitalization (<3 months) for severe medical disease
    2. symptomatic peripheral arterial occlusive disease
    3. orthopedic or chronic pain conditions restricting exercise
    4. pulmonary or renal failure
    5. active cancer
    6. poorly controlled hypertension (>160/100) or diabetes mellitis (fasting glucose>180 mg/dl, HbA1C >10%)
  • Neurological history of

    1. dementia
    2. receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2 point commands
    3. 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

    First Posted
    January 31, 2008
    Last Updated
    May 27, 2015
    Sponsor
    Andreas R Luft
    Collaborators
    Robert Bosch Medical Center, Max-Planck-Institute Tuebingen
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    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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