跳至主要内容
临床试验/NCT02057354
NCT02057354已完成不适用

Aerobic Exercise, Neurotrophins, and fMRI of Hippocampal Function and Structure

Boston University1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
1
主要终点
MRI

研究概览

简要总结

The investigators are examining the effects of exercise and cardiovascular fitness on cognitive processes, brain function, and the amount of several proteins in the blood. These proteins include a hormone called cortisol, also known as the "stress hormone," and a growth factor called "brain-derived neurotrophic factor" (BDNF). The "stress hormone" cortisol is produced by the adrenal glands. Stress, exercise, obesity, and other factors may influence cortisol levels. BDNF is a protein that promotes the health of nerve cells in the brain and in the body. It plays a role in the growth, maturation, and maintenance of these cells. The amount of this protein in blood samples is therefore an indicator of healthy nerve cell function. Here, the investigators are investigating if exercise improves brain function by changing BDNF levels. Participation in this research study will take approximately 4 months. During this time, participants will make four initial study visits. The first visit is for informed consent and screening, the second and third visits are for baseline fitness testing, and the fourth visit is for a blood draw, cognitive testing, and a functional Magnetic Resonance Imaging (fMRI) exam. Functional MRI is a brain imaging technique that uses a magnetic field to "take pictures" of the brain while a person performs a given task. It will take up to approximately three weeks to complete these initial four study visits. Following the four initial study visits, the exercise-training program will begin. Participants will be randomized to one of two training programs: an aerobic exercise program and a non-aerobic exercise program consisting of strengthening, balance and stretching exercises. The exercise training program will last 12 weeks. There will be three one-hour exercise sessions per week. After completion of the exercise-training program, participants will attend three follow-up study visits. The first two follow-up visits are for fitness testing. The third and final follow-up visit is for a blood draw, cognitive testing, and an MRI exam.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Non-smoking
  • •Age between 18-35 years or between 55-85 years
  • •Sedentary status (physically inactive)
  • •Generally healthy
  • •Native-English speaker

排除标准

  • •Diagnosis of severe anemia
  • •Past or present condition that affect cognitive functioning:
  • •learning disability
  • •neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
  • •psychiatric disorders or conditions (depression, anxiety disorder, etc.)
  • •Poor vision that cannot be corrected with glasses or contact lenses
  • •Presence of an infection
  • •Diagnosis of kidney failure
  • •Diagnosis of liver disease
  • •Diagnosis of thyrotoxicosis/hyperthyroidism
  • •Diagnosis of cancer
  • •Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and physical exercise:
  • •heart (e.g. heart attack, arrhythmias, etc.)
  • •circulatory (e.g. uncontrolled hypertension, high cholesterol, etc.)
  • •respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)
  • •current musculoskeletal impairments (e.g. leg claudication, fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)
  • •diagnosis of electrolyte disorder or abnormality
  • •presence of diabetes mellitus
  • •Claustrophobia (fear of small, encloses spaces)
  • •Female subjects: breast-feeding or potentially pregnant
  • •Eating disorder
  • •Compulsive exercising
  • •Ferro-magnetic metal in or on the body that cannot be removed (e.g. pacemaker, defibrillator, permanent tattoo or eyeliner with metallic specks)
  • •Prescription medication or other drugs that are cardio-active
  • •Prescription medication or other drugs that are psycho-active
  • •Drug abuse or alcohol misuse
  • •Regularly exercising
  • •Unavailable for the approximately 4-month duration of the study

研究组 & 干预措施

Healthy Sedentary Young Adults

Active Comparator

Participants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.

干预措施: Aerobic Exercise (Behavioral)

Healthy Sedentary Young Adults

Active Comparator

Participants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.

干预措施: Non-Aerobic Exercise (Behavioral)

Healthy Sedentary Older Adults

Experimental

Participants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.

干预措施: Aerobic Exercise (Behavioral)

Healthy Sedentary Older Adults

Experimental

Participants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.

干预措施: Non-Aerobic Exercise (Behavioral)

结局指标

主要结局

MRI

时间窗: 1.5 to 2 hours each at Visits 4 and 43

Measurement of brain activity during task performance and measurement of change in regional brain volumes.

Serum BDNF level

时间窗: 5 minutes each at Visits 4 and 43

Fasting blood draw on same day of MRI to measure change in serum BDNF from baseline to follow-up

Memory test performance

时间窗: 1.5 to 2 hours each at Visits 4 and 43

Participants will perform recognition memory tests during and after functional MRI. Measurements include baseline-to-follow-up change in reaction times and accuracy.

次要结局

  • Aerobic capacity and muscle strength(80 min each at Visits 2, 3, 41 and 42)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karin Schon

Assisstant Professor, Department of Anatomy & Neurobiology, BUSM

Boston University

研究点 (1)

Loading locations...

相似试验

Neuroimaging Study of Exercise and Memory Function | 临床试验