Effect of Aerobic Exercise Training on Cardiorespiratory Fitness in Patients With Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in peak oxygen consumption
研究概览
简要总结
Background:
- Many people who have traumatic brain injury (TBI) have low levels of physical fitness. Low physical fitness causes severe fatigue that reduces the ability to perform routine daily activities, and may also cause increased depression, anxiety, or sadness. Aerobic exercise, such as treadmill walking or running, improves physical fitness in most people and may also decrease fatigue and improve mood. However, more information is needed to determine if exercise improves these conditions in people who have TBI.
Objectives:
- To examine the effect of an aerobic treadmill walking exercise program on physical fitness, fatigue, and mood in people with TBI.
Eligibility:
- Individuals between 21 and 45 years of age who had a nonpenetrating traumatic brain injury at least 6 months before participating; able to understand oral and written English language, give informed consent and sign a consent form; are physically inactive (including activities related to both job and recreation); and are able to stand and walk on a treadmill safely without help.
Design:
- This study requires 4 testing visits and 36 exercise visits over 14 weeks.
- The first and third testing visits will last about 4 hours and the second and final testing visits will take about 2 hours.
- Testing visits will consist of a medical history and physical examination, completion of questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test.
- Participants will have treadmill exercise training 3 days per week for 12 weeks. Each session includes a check-in, warm-up, treadmill walking at the training heart rate, and cool-down. Thirty-two of the sessions will last for about 1 hour, and four of the sessions will include questionnaires to fill out and will last about one-and-a-half hours.
- After completing the exercise training program, participants will have a final testing visit to complete the questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test.
详细描述
Objective
The broad objective of this exploratory project is to inform clinical studies and trials on the use of aerobic exercise training (AET) as an intervention for improving cardiorespiratory fitness in patients with traumatic brain injury (TBI). AET-induced adaptation of cardiorespiratory fitness and fatigue severity will be characterized, and time-course for changes in mood reactivity will be determined. We hypothesize that 1) AET will improve both cardiorespiratory fitness and fatigue severity 2) mood will at first worsen in response to AET but that mood reactivity will then decrease at some point during the intervention, and 3) AET will not impair overall cognitive performance, but that the specific cognitive performance areas of attention and concentration will improve with AET.
Study Population
Thirty-six adult subjects with a clinical diagnosis of non-penetrating TBI (mild, moderate, and severe) will be enrolled. Subjects will be recruited from NIH, affiliated hospitals/clinics, and in the community.
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Subjects eligible for participation in this research study must meet the following inclusion criteria:
- •Diagnosis of non-penetrating mild, moderate, or severe TBI
- •Injury occurred at least 6 months prior to enrollment
- •Age 21-45 years
- •Physically inactive as identified by a physician.
- •Able to stand and walk on a treadmill independently and safely without assistance
- •Able to follow the study protocol
- •Fluent in English and able to provide informed consent
- •Willing and safely able to forego starting or changing an exercise program or treatments that would potentially alter cardiorespiratory capacity or ability to exercise and/or treatment for mood disorders
排除标准
- •Subjects are not eligible for participation in this research study if any of the following medical conditions that would impair aerobic capacity or the ability to engage in physical activity exist, including diseases of the cardiovascular (other than hypertension controlled by medication to below 140/90 mmHg), pulmonary, neurological, metabolic, or musculoskeletal systems such as:
- •Diagnosis or history of ischemic heart disease, including those with CABG and PTCA
- •Dilated or hypertrophic cardiomyopathy
- •Non-idiopathic cardiomyopathy
- •Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg
- •Diagnosis or history of right or left-sided heart failure or pulmonary hypertension
- •Diagnosis or history of restrictive or obstructive lung disease
- •Diagnosis or history of stroke
- •Type I or Type II Diabetes Mellitus
- •Diagnosis of chronic kidney disease, chronic liver disease, acute kidney injury or acute liver failure
- •Metastatic cancer active within the previous five years
- •Mitochondrial disease
- •On medications that would influence aerobic capacity, the ability to adapt to exercise training, or treadmill performance such as beta blockers or antiretroviral therapy
- •Active substance abuse including ETOH
- •Ongoing tobacco use (any use within the past six months)
- •Medical or Psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
- •BMI greater than 40 kg/m(2)
研究组 & 干预措施
Exercise
Aerobic exercise performed for 12 weeks
干预措施: Aerobic Exercise Training (Other)
结局指标
主要结局
Change in peak oxygen consumption
时间窗: Pre and post
The peak VO2 as measured by gas exchange during a cardiopulmonary exercise test to volitional exhaustion.
次要结局
未报告次要终点