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:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT03674320
Eligibility Criteria:
Inclusion Criteria:
1. Aged 40 - 80 years
2. Stable weight (\<10 lbs change in past 12 months - self reported)
3. (Willing to) participate in pulmonary rehabilitation (PR) program at UTMB
4. Air flow limitation based on spirometry (FEV1 \< 60% predicted) (prior to PR)
5. Daily symptoms according to COPD assessment test (CAT) \> 15 (prior to PR)
Exclusion Criteria:
1. Late stage COPD, GOLD Stage 3-4 (FEV1 \> 60% predicted)
2. Inability to perform 6-minute walking test or other physical therapy activities
3. Inability/unwillingness to follow the pulmonary rehabilitation program
4. Already more than 2 weeks into the pulmonary rehabilitation program at time of consenting
5. Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes)
6. Uncontrolled hypertension. Systolic blood pressure greater than or equal to 160mm Hg or a diastolic blood Pressure greater than or equal to 100mm Hg on three consecutive measurements taken at one-week intervals. Testosterone can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria
7. History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months
8. LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL cholesterol levels 9. Hematocrit greater than 51%
10\. Current use of or history of recent anabolic steroid use (within 3 months) 11. Current abuse of alcohol or recreational drugs 12. Any other condition or event considered exclusionary by the PIs and covering faculty physician 13. Vulnerable populations including: individuals unable to consent on their own behalf, prisoners and pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03674320
Study Brief:
Protocol Section:
NCT03674320