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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07346261
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of chronic obstructive pulmonary disease (COPD), moderate to severe (GOLD stage II-IV)
2. FEV₁ \> 80% of predicted.
3. Age 50-65 years.
4. Able to perform high-intensity respiratory muscle training (MIP and MEP ≥ device threshold).
5. Clinically stable with no acute exacerbations.
Exclusion Criteria:
1. Severe comorbidities (e.g., coronary heart disease, arterial aneurysm, severe hepatic or renal dysfunction, uncontrolled hypertension).
2. Unstable medical conditions or other respiratory diseases that could cause or contribute to breathlessness (e.g., asthma, pneumonia, bronchiectasis, tuberculosis, interstitial lung disease).
3. Mental illness, deafness, limb activity disorder, or any condition causing inability to cooperate with procedures.
4. Cognitive impairment or psychiatric illness that affects cooperation.
5. Participation in another clinical trial or intervention within the last 3 months.
6. Current use of any other respiratory muscle training device or app.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
60 Years
Study:
NCT07346261
Study Brief:
Protocol Section:
NCT07346261