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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT05119556
Eligibility Criteria:
Inclusion Criteria:
1. Age 40 or greater
2. Clinical diagnosis of COPD
3. Hospitalized for acute exacerbation of COPD.
4. Be willing to adhere to trial and follow-up procedures and give informed consent
Exclusion Criteria:
1. Secondary diagnosis of congestive heart failure that is severe as documented by active symptoms, New York Heart Association (NYHA) functional classification IV or left ventricular ejection fraction \<25% on echocardiography
2. Other respiratory conditions that could confound the diagnosis such as asthma, pulmonary fibrosis, bronchiectasis, and lung cancer. Participants with pneumonic exacerbations of COPD will be included.
3. Primary diagnosis of COVID pneumonia. Individuals with incidentally detected COVID or persistently positive for COVID but deemed to be convalescent will not be excluded.
4. Active cancers on chemotherapy or radiation therapy
5. Immunosuppressed states predisposing to frequent hospitalizations including uncontrolled HIV/AIDS
6. Active or recent (within 1 month) myocardial infarction
7. Angina not well-controlled by medication
8. Unstable cardiac arrhythmias, atrial or ventricular
9. Supplemental oxygen requirement greater than 5 liters per minute at either rest or with exertion
10. Significant cognitive dysfunction, including dementia, that in opinion of investigator would impair ability to safely or effectively engage in study protocol
11. Participants with any terminal medical illnesses as diagnosed by a physician, and/or on hospice
12. Currently enrolled in and participating in pulmonary rehabilitation
13. Treatment with chronic or newly initiated home ventilatory support. Those on in-patient short-term non-invasive ventilation will not be excluded.
14. Special patient groups such as prisoners and institutionalized patients
15. Participants with musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program
16. Current participation in any other interventional clinical trial
17. Inability to understand and speak English during exercise sessions
18. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05119556
Study Brief:
Protocol Section:
NCT05119556