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Effect of Lifestyle Changes on BDNF Level After Stroke

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ClinicalTrials.gov Identifier: NCT03701815
Recruitment Status : Unknown
Verified October 2018 by Jeffrey Krauss, VA Palo Alto Health Care System.
Recruitment status was:  Recruiting
First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Collaborators:
Stanford University
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Jeffrey Krauss, VA Palo Alto Health Care System

Study Description
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Brief Summary:
This is a pilot study to determine whether a lifestyle medicine intervention following stroke may increase levels of Brain-Derived Neurotrophic Factor (BDNF).

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Wellness in Rehabilitation program Not Applicable

Detailed Description:

This is a substudy of the study entitled "Assessing a Multi-Disciplinary Lifestyle Medicine Intervention Following Stroke," specifically looking at the effects of lifestyle change on brain-derived neurotrophic factor (BDNF). BDNF has emerged as a key facilitator of neuroplasticity to improve motor learning and rehabilitation after stroke. Aerobic exercise has been shown to increase levels of BDNF in multiple parts of the central nervous system and therefore may facilitate neuroplasticity and motor recovery. While BDNF levels appear to be increased for up to 1 hour following a bout of aerobic exercise, it is unclear whether regular aerobic exercise over weeks to months can increase baseline BDNF levels in humans following stroke.

An single nucleotide polymorphism exists on the BDNF gene in 30-50% of the human population that results in an amino acid change from valine (val) to methionine (met) at position 66 (val66met) of the precursor peptide proBDNF. The presence of the met allele results in a 25% reduction in activity-dependent secretion of BDNF in the CNS.

The Wellness in Rehabilitation program at the VA Palo Alto Health Care System is a lifestyle medicine intervention for patients following stroke. It is a 12-week program involving weekly meetings that include exercise (particularly aerobic exercise), nutrition, stress management, education, and group support. Participants are encouraged to perform healthy lifestyle behaviors (i.e. exercise) daily at home, and a health coach calls each patient weekly to support the behavior change process.

Participants in the Wellness in Rehabilitation program who elect to participate in the research study will have blood drawn at baseline, week 6, and week 12. Blood draws will be performed in the morning prior to exercise, and week 6 will additionally include a blood draw within 30 minutes of completing a bout of aerobic exercise. Following completion of the study, plasma BDNF levels (measured as nanograms per milliliter) will then be measured at all 4 time points (baseline, week 6 pre-exercise, week 6 post-exercise, and week 12). In addition, BDNF genotype will be measured using the baseline sample. Participants will also complete bike or treadmill exercise testing at baseline and week 12 to determine pre- and post-program cardiovascular fitness levels (measured as VO2 max and estimated metabolic equivalents), and will also complete a 6-minute walk test. They will be asked to record their exercise daily and will additionally complete the Physical Activity Scale for Individuals with Physical Disabilities at baseline and week 12 time points.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Effect of Multi-disciplinary Lifestyle Medicine Intervention on Brain-derived Neurotrophic Factor Levels Following Stroke
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : January 11, 2019
Estimated Study Completion Date : February 28, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Post-stroke
Patients will receive a 12-week lifestyle medicine program.
 Behavioral: Wellness in Rehabilitation program
The 12-week Wellness in Rehabilitation program includes weekly in-person meetings including aerobic exercise, nutrition/cooking training, stress management techniques, education, and group support. A health coach will facilitate continuation of healthy behaviors at home.
Other Name: Lifestyle Medicine program


Outcome Measures
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Primary Outcome Measures :
  1. BDNF level - Final [ Time Frame: Week 12 ]
    Plasma BDNF protein levels, expressed in nanograms per milliliter, measured prior to any exercise upon completion of intervention.


Secondary Outcome Measures :
  1. BDNF level - Post-exercise [ Time Frame: Week 6 ]
    Plasma BDNF protein levels, expressed in nanograms per milliliter, measured immediately following bout of aerobic exercise.

  2. BDNF Genotype [ Time Frame: Baseline ]
    Genotyping of venous blood samples to determine ValVal, MetMet, and ValMet distribution.

  3. Cardiovascular Fitness - VO2 max [ Time Frame: Week 12 ]
    Measured as VO2 max (ml/kg/min).

  4. Cardiovascular Fitness - METs [ Time Frame: Week 12 ]
    Measured as estimated metabolic equivalents (kcal/kg/hour).

  5. 6-minute Walk Test [ Time Frame: Week 12 ]
    Total distance walked 6 minutes on a flat surface.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of prior stroke (ischemic or hemorrhagic) or transient ischemic attack
  • Ability to ambulate at least 10 feet with minimal to moderate assistance
  • Ability to travel to intervention site on a weekly basis.

Exclusion Criteria:

  • Cerebral aneurysm
  • Concurrent pregnancy
  • Serious terminal illnesses (e.g. end stage renal disease, heart failure (class IV), cirrhosis (class C), metastatic cancer)
  • Any injury or illness preventing participation in regular aerobic exercise
  • Moderate-severe dementia or cognitive decline
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701815


Contacts
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Contact: Jeffrey Krauss, MD 6504935000 ext 65525 jkrauss@stanford.edu
Contact: Windy McNerney, PhD 6504935000 windymc@stanford.edu

Locations
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United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Jeffrey Krauss, MD    650-493-5000 ext 65525    jeffrey.krauss@va.gov   
Sponsors and Collaborators
VA Palo Alto Health Care System
Stanford University
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: Jeffrey Krauss, MD VA Palo Alto Health Care System, Stanford University
More Information
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Responsible Party: Jeffrey Krauss, Staff Physician, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT03701815    
Other Study ID Numbers: KRU001
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Krauss, VA Palo Alto Health Care System:
brain-derived neurotrophic factor
exercise
BDNF
lifestyle medicine
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases