Aerobic Exercise to Improve Brain Metabolism in MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Comparison of correlations in changes in VO2Max at 12 weeks with changes in brain ATP production at 12 weeks between aerobic exercise group and stretching group.
研究概览
简要总结
The purpose of this study is to learn more about multiple sclerosis (MS). The investigators are studying whether aerobic exercise is better than a stretching program at improving brain health in people with MS. We want to learn:
- If it is safe and practical for people with MS to participate in an aerobic exercise program with the goal of increasing cardiac fitness. Cardiac fitness is measured with exercise stress tests at the beginning and end of the study.
- If aerobic exercise improves brain metabolism, a reflection of brain health, more than stretching. Brain metabolism is measured by MRIs at the beginning and end of the study.
There is a 50% chance of being in the aerobic exercise or the stretching program.
There are between 8 and 36 visits to OHSU, depending on the intervention group. The total duration of the study is at most 21 weeks.
详细描述
Multiple sclerosis (MS) is a disease of brain, spinal cord and optic nerves. Current MS therapies reduce the frequency and severity of MS flare-ups, but do not help MS in later stages of disease characterized by slow progression of disability. One obstacle to developing therapies for progressive aspects of disease is a lack of ability to measure progression and brain repair.
A new MRI technique developed by Bill Rooney, PhD, (co-investigator, OHSU Advanced Imaging Resource Center) looks at brain health by measuring levels of phosphorous. Phosphorous levels are thought to reflect energy stores produced by brain cells. The healthier the brain, the greater the energy stores seen as higher the levels of phosphorous on imaging. Dr. Rooney has shown decreased levels of phosphorous on brain MRIs from people with MS. We propose that therapies that boost brain cell health will lead to an increase in brain cell energy stores and be reflected by an increase in phosphorous levels on MRI spectroscopy.
In order to test whether improvements in brain energy stores can be seen as increased phosphorous levels, we will use a therapy known to improve energy stores in muscles and see if it also does so in the brain. We measure how much aerobic exercise increases energy stores in muscles by measuring oxygen utilization during an exercise stress test. Therefore in this study, we will see if the aerobic exercise that improves muscle energy stores (seen as an increase in oxygen utilization) corresponds to an increase in brain energy stores (seen as an increase in phosphorous levels).
Specific Aim 1. To determine if it is safe and feasible to conduct an aerobic exercise intervention in MS patients to achieve an increase in oxygen utilization by 5-15%.
Hypothesis: An MS cohort undergoing a structured aerobic exercise program will increase their aerobic capacity by 5-15% as measured by oxygen utilization testing and not experience adverse events related to the exercise program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Physician-confirmed diagnosis of relapsing-remitting MS ii. > 18 years old iii. Expanded Disability Status Scale (EDSS) < 4.0 iv. Able to give informed consent
排除标准
- •i. Current cardiopulmonary disease requiring treatment (hypertension permitted) ii. Medical or biophysical conditions that do not permit use of either a cycle ergometer or treadmill iii. MRI contraindications (pacemaker, wires, defibrillator, or implanted heart valves, head surgery requiring aneurysm clips, or any type of electric device (stimulator or pump) implanted in the body) iv. MS exacerbation in the last 30 days v. Pregnant women: Pregnancy status determined by menstrual history and contraceptive method. Confirmatory urine pregnancy test will be used if pregnancy status is uncertain
研究组 & 干预措施
Aerobic Exercise, Healthy Subjects
干预措施: Aerobic Exercise- Healthy Subjects (Behavioral)
Aerobic Exercise
干预措施: Aerobic Exercise (Behavioral)
Stretching Program
干预措施: Stretching (Behavioral)
结局指标
主要结局
Comparison of correlations in changes in VO2Max at 12 weeks with changes in brain ATP production at 12 weeks between aerobic exercise group and stretching group.
时间窗: Baseline, Twelve Weeks
1. Changes in VO2Max testing consists of an aerobic exercise test on a treadmill or stationary bicycle to measure blood pressure, heart rate, and oxygen consumption, and lung function tests 2. Brain ATP production is measured using a 31P MRSI imaging procedure: MRI data is collected using 7 tesla MRI instrument. All MRI data will be collected within 1.25 hour on each session (2.5 hour total/subject).
次要结局
- Changes in fatigue at 12 weeks(Baseline, Twelve Weeks)
- Changes in Cognition at 12 weeks(Baseline, Twelve Weeks)
研究者
Rebecca Spain
Assistant Professor
Oregon Health and Science University
