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临床试验/NCT03701815
NCT03701815Unknown不适用

Assessing the Effect of Multi-disciplinary Lifestyle Medicine Intervention on Brain-derived Neurotrophic Factor Levels Following Stroke

VA Palo Alto Health Care System2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年1月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
2
主要终点
BDNF level - Final

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

BDNF level - Final

时间窗: Week 12

Plasma BDNF protein levels, expressed in nanograms per milliliter, measured prior to any exercise upon completion of intervention.

次要结局

  • Cardiovascular Fitness - VO2 max(Week 12)
  • Cardiovascular Fitness - METs(Week 12)
  • BDNF Genotype(Baseline)
  • 6-minute Walk Test(Week 12)
  • BDNF level - Post-exercise(Week 6)

研究者

发起方
VA Palo Alto Health Care System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Jeffrey Krauss

Staff Physician

VA Palo Alto Health Care System

研究点 (2)

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