Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT02504866
Eligibility Criteria:
* INCLUSION CRITERIA:
Inclusion criteria for those with TBI:
1. Ages 18 to 79 inclusive
2. Diagnosis of non-penetrating TBI
3. Injury occurred at least 12 months prior to enrollment
4. Physically inactive as identified by a physician
5. Able to stand and walk independently and safely without any assistance
6. Able to follow the study protocol
7. Fluent in English and able to provide informed consent
Inclusion criteria for healthy volunteers:
1. Ages 18 to 79 inclusive
2. Physically inactive as identified by a physician
3. Fluent in English
EXCLUSION CRITERIA:
Exclusion criteria for those with TBI:
1. History of exercise intolerance
2. History of heart disease
3. History of pulmonary disease, other than controlled, non-exercise-induced asthma
4. History of uncontrolled diabetes
5. Uncontrolled hypertension, defined as a resting blood pressure \> 140/90 mmHg
6. On medications that would influence aerobic capacity or treadmill performance such as beta blockers or antiretroviral therapy
7. Active substance abuse including ETOH
8. 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
9. Unable to refrain from smoking at least 4 hours prior to exercise testing sessions
10. Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
11. Pregnancy
12. BMI \>40 kg/M(2) due to the limits of the treadmill, elliptical machine and MRI scanner
13. Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function
14. Have any of the following contraindications to having an MRI scan:
1. A ventriculo-peritoneal shunt
2. Have claustrophobia and not comfortable in small enclosed spaces
3. 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).
4. Excessive startle reaction to or fear of loud noises
Exclusion criteria for healthy volunteers:
1. History or presence of cardiopulmonary or respiratory disease
2. History or presence of other disease of the neurologic, metabolic, or renal systems
3. Active substance abuse including ETOH
4. Pregnancy
5. BMI \>40 kg/m2
6. Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
7. Have any contraindications to having an MRI scan
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02504866
Study Brief:
Protocol Section:
NCT02504866