Structural Neuroplasticity Associated With Aerobic Treadmill Training in Geriatric Chronic Stroke Survivors

NCT00614224 | Completed

• 1 other identifier: BOSCH-TAEX-001
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (2)

• aerobic capacity (peak VO2)

  Baseline (timepoint 0) and after training (3 months)

• gait velocity

  Baseline (timepoint 0) and after training (3 months)

Secondary Outcomes (3)

• cortical thickness (MRI)

  Baseline (timepoint 0) and after training (3 months)

• grey matter density (VBM-MRI)

  Baseline (timepoint 0) and after training (3 months)

• cerebrovascular reserve capacity (ASL-MRI)

  Baseline (timepoint 0) and after training (3 months)

Study Arms (2)

A

EXPERIMENTAL

Treadmill training group (TAEX)

Behavioral: treadmill exercise training

B

ACTIVE COMPARATOR

Attention control group (CON)

Behavioral: treadmill exercise training

Interventions

treadmill exercise training BEHAVIORAL

3 months (3 times/week) progressive graded aerobic treadmill training with a duration of 10-45 min per training session

A; B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andreas R Luft: lead
• Robert Bosch Medical Center: collaborator
• Max-Planck-Institute Tuebingen: collaborator

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 28, 2015

Record last verified: 2008-01