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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT07261293
Eligibility Criteria:
Inclusion Criteria:
* Individuals aged between 40 and 80 years
* Clinically stable patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2024 criteria with post-bronchodilator FEV₁/FVC \< 0.70
* Stable clinical condition (no acute exacerbation within the past 4 weeks)
* Individuals clinically evaluated and approved as suitable for pulmonary rehabilitation (PR) participation by a cardiology specialist
* Functional capacity sufficient to participate in PR (e.g., 6-Minute Walk Test ≥150 m)
* No contraindications to blood flow restriction (BFR) training (e.g., no peripheral vascular disease, no active thrombosis)
* Ability to understand and follow instructions (adequate auditory and cognitive function)
Exclusion Criteria:
* Acute exacerbation of COPD, hospitalization, or systemic corticosteroid treatment within the past 4 weeks
* Severe cardiovascular disease (uncontrolled hypertension \>180/110 mmHg, myocardial infarction within the past 6 months, unstable angina, congestive heart failure NYHA Class III-IV)
* Neurological or orthopedic conditions significantly limiting lower-extremity function (e.g., hemiplegia, amputation, severe osteoarthritis, knee prosthesis)
* Severe renal impairment (GFR \<30 mL/min/1.73 m²) or severe hepatic failure
* History of lower-extremity surgery within the past 3 months
* Active malignancy or systemic infection
* Anemia or chronic inflammatory/autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
* History of venous thromboembolism
* Peripheral arterial disease
* Physician-diagnosed sarcopenia
* Psychiatric disorders (major depression, dementia, psychotic disorders) limiting adherence to the study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT07261293
Study Brief:
Protocol Section:
NCT07261293