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 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT05572632
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Willingness to participate in the COPD Wellness program
* 40 to 90 years old
* English or Spanish speaking
* Physician-diagnosed COPD
* Spirometry-confirmed FEV1/FVC ratio \<= 0.7 and FEV1% predicted \<80% based on GLI-O prediction equation
* COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy
* Currently prescribed COPD medication(s)
* Ability to exercise with lower extremities
* No COPD exacerbations for ≥ 6 weeks
* Currently receiving care within SFHN
* Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC)
Exclusion Criteria:
* Pregnancy
* Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating
* Unstable cardiovascular disease (includes recent \[\<6 months\] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure)
* Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist)
* Transmittable pulmonary infection (tuberculosis, COVID19)
* Participated in pulmonary rehabilitation in the past 12-months
* COPD exacerbation in the past 6 weeks
* Activities restrictions that limit one's ability to engage in moderate physical activity
* Other diagnosis or condition that carry a prognosis of death within the next year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT05572632
Study Brief:
Protocol Section:
NCT05572632