Effect of Lifestyle Changes on BDNF Level After Stroke
Assessing the Effect of Multi-disciplinary Lifestyle Medicine Intervention on Brain-derived Neurotrophic Factor Levels Following Stroke
1 other identifier
interventional
12
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2018
CompletedFirst Submitted
Initial submission to the registry
September 27, 2018
CompletedFirst Posted
Study publicly available on registry
October 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedOctober 10, 2018
October 1, 2018
12 months
September 27, 2018
October 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BDNF level - Final
Plasma BDNF protein levels, expressed in nanograms per milliliter, measured prior to any exercise upon completion of intervention.
Week 12
Secondary Outcomes (5)
BDNF level - Post-exercise
Week 6
BDNF Genotype
Baseline
Cardiovascular Fitness - VO2 max
Week 12
Cardiovascular Fitness - METs
Week 12
6-minute Walk Test
Week 12
Study Arms (1)
Post-stroke
EXPERIMENTALPatients will receive a 12-week lifestyle medicine program.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Palo Alto Health Care Systemlead
- Stanford Universitycollaborator
- Spaulding Rehabilitation Hospitalcollaborator
Study Sites (1)
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Krauss, MD
VA Palo Alto Health Care System, Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
September 27, 2018
First Posted
October 10, 2018
Study Start
January 19, 2018
Primary Completion
January 11, 2019
Study Completion
February 28, 2019
Last Updated
October 10, 2018
Record last verified: 2018-10