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 @ 9:35 PM
Ignite Modification Date:
2025-12-24 @ 9:35 PM
NCT ID:
NCT01294332
Eligibility Criteria:
* INCLUSION CRITERIA:
Subjects eligible for participation in this research study must meet the following inclusion criteria:
1. Diagnosis of non-penetrating mild, moderate, or severe TBI
2. Injury occurred at least 6 months prior to enrollment
3. Age 21-45 years
4. Physically inactive as identified by a physician.
5. Able to stand and walk on a treadmill independently and safely without assistance
6. Able to follow the study protocol
7. Fluent in English and able to provide informed consent
8. 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
EXCLUSION CRITERIA:
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:
1. Diagnosis or history of ischemic heart disease, including those with CABG and PTCA
2. Dilated or hypertrophic cardiomyopathy
3. Non-idiopathic cardiomyopathy
4. Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg
5. Diagnosis or history of right or left-sided heart failure or pulmonary hypertension
6. Diagnosis or history of restrictive or obstructive lung disease
7. Diagnosis or history of stroke
8. Type I or Type II Diabetes Mellitus
9. Diagnosis of chronic kidney disease, chronic liver disease, acute kidney injury or acute liver failure
10. Metastatic cancer active within the previous five years
11. Mitochondrial disease
12. On medications that would influence aerobic capacity, the ability to adapt to exercise training, or treadmill performance such as beta blockers or antiretroviral therapy
13. Active substance abuse including ETOH
14. Ongoing tobacco use (any use within the past six months)
15. Medical or Psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
16. Pregnancy
17. BMI greater than 40 kg/m(2)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT01294332
Study Brief:
Protocol Section:
NCT01294332