Effect of Exercise Training on Physical, Cognitive and Behavioral Function in Patients With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B)
研究概览
简要总结
Background:
- Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking and emotions. Exercise can improve these things in people with other brain damage. Researchers want to look at the effect of exercise on these things in people with TBI.
Objectives:
- To study how head injuries affect the brain. To study if exercise can help some symptoms in people with TBI. These include problems thinking, balancing, and moving, and depression or anxiety.
Eligibility:
- People age between 18 and 79
- Had a non-penetrating TBI at least 12 months ago
- Are physically inactive, but can stand and walk without help
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They may have a balance test.
- Participants will be assigned to a high-intensity or a lower-intensity exercise program.
- The study is 6 months long. There will be 3 months with exercise on an elliptical machine and 3 months without exercise.
- Participants will exercise for 30 minutes on an elliptical machine, 3 days per week for 3 months.
- Participants will also have 3 outpatient testing visits lasting approximately 8 hours, once every 3 months. This visit will include:
- Blood tests
- Tests for memory, attention, and thinking
- Tests of walking and balance
- Questionnaires
- An MRI: they will lie in a machine that takes pictures of their brain, while breathing regular air and air with more carbon dioxide
- Test of physical fitness
详细描述
Objective
The broad objective of this study is to examine the effects of moderate and more intense aerobic exercise as an intervention on cognitive performance, physical functioning and health-related quality of life in patients with chronic (more than 12 months post-injury) traumatic brain injury (TBI). Importantly, structural and biological brain changes will be measured to examine whether functional outcomes are related to exercise-induced adaptations. It is hypothesized that in the chronic phase of persons with TBI, there will be improved: 1) cognitive function, 2) physical fitness and fatigue severity, 3) motor performance and balance, and 4) mood and depressive symptoms, in those that performed the exercise intervention compared to a control group. It is also hypothesized that these functional improvements will be related to exercise intensity, improved cortical connectivity, dopamine transmission gene scores, and blood biomarkers related to neuro and angio-genesis.
Study Population
80 ambulatory adults with non-penetrating TBI will be enrolled. We will also enroll up to 20 healthy volunteers as a comparison group for some of the outcome measures. Subjects will be recruited from NIH, affiliated hospitals/clinics and the community
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Inclusion criteria for those with TBI:
- •Ages 18 to 79 inclusive
- •Diagnosis of non-penetrating TBI
- •Injury occurred at least 12 months prior to enrollment
- •Physically inactive as identified by a physician
- •Able to stand and walk independently and safely without any assistance
- •Able to follow the study protocol
- •Fluent in English and able to provide informed consent
- •Inclusion criteria for healthy volunteers:
- •Ages 18 to 79 inclusive
- •Physically inactive as identified by a physician
- •Fluent in English
排除标准
- •Exclusion criteria for those with TBI:
- •History of exercise intolerance
- •History of heart disease
- •History of pulmonary disease, other than controlled, non-exercise-induced asthma
- •History of uncontrolled diabetes
- •Uncontrolled hypertension, defined as a resting blood pressure > 140/90 mmHg
- •On medications that would influence aerobic capacity or treadmill performance such as beta blockers or antiretroviral therapy
- •Active substance abuse including ETOH
- •Presence of an injury to any extremity, or other medical condition that would affect motor function or the ability to perform the assessment or the exercise program, specifically balance problems due to vestibulopathy
- •Unable to refrain from smoking at least 4 hours prior to exercise testing sessions
- •Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
- •BMI >40 kg/M(2) due to the limits of the treadmill, elliptical machine and MRI scanner
- •Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function
- •Have any of the following contraindications to having an MRI scan:
- •A ventriculo-peritoneal shunt
- •Have claustrophobia and not comfortable in small enclosed spaces
- •Have metal that would make an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion devise, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes).
- •Excessive startle reaction to or fear of loud noises
- •Exclusion criteria for healthy volunteers:
- •History or presence of cardiopulmonary or respiratory disease
- •History or presence of other disease of the neurologic, metabolic, or renal systems
- •Active substance abuse including ETOH
- •BMI >40 kg/m2
- •Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
- •Have any contraindications to having an MRI scan
研究组 & 干预措施
Aerobic Exercise Intervention (AET)
Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks
干预措施: Vigorous exercise (Other)
Rapid-Resistive Exercise Intervention (RET)
Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks
干预措施: Light to moderate exercise (Other)
Waitlist Control (CON)
Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either AET or RET after the initial 12 weeks
结局指标
主要结局
Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B)
时间窗: Before (pre) and after (post) 12 weeks intervention
Trail Making Test (TMT) is a neuropsychological assessment of visual conceptual and visual motor tracking (involves motor speed and attention functions). Trail Making Test Part B (TMT-B) is associated with executive functioning and involves drawing a line connecting alternating numbers and letters in sequence (i.e., 1-A-2-B and so on). The time to complete the test is recorded. The time taken to complete the test was converted into standardized T-scores, representing a mean of 50 and a standard deviation of 10. Higher T-scores mean less cognitive deficits. The change in cognitive function was reported as the change in TMT-B T-scores across the 12 weeks (post minus pre intervention).
次要结局
未报告次要终点