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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT05806294
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (18+)
* COPD stage 1 or 2
* Identified by their family doctor as having at least two out of five MetS factors
* Adjusted body mass index (BMI) between 26 to 40
* Able to provide written informed consent in English
Exclusion Criteria:
* Inability to speak, read or understand English
* Having a medical or physical condition that makes moderate-intensity physical difficult or unsafe
* Diagnosis of Type 1 diabetes mellitus or type 2 diabetes mellitus with proliferative diabetic retinopathy, nephropathy (serum creatine \> 160 µmol/L), clinically significant neuropathy (defined as absent ankle jerks), severe hyperglycemia (fasting blood glucose \> 11 mmol/L), or claudication symptoms
* Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), COPD stages 3 or 4, heart failure stage D, stroke, and ongoing substance abuse, undergoing active treatment for cancer
* Clinically significant renal failure (.i.e., creatinine \> 200 µmol/L)
* Diagnosis of psychiatric disorders that would limit the adequate ability to comply with the study protocol
* Unable or unwilling to use technology to meet with the healthcare team and My Viva Plan to manage self-care
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05806294
Study Brief:
Protocol Section:
NCT05806294