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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT02473705
Eligibility Criteria:
Inclusion Criteria:
* Referred to Cardiac Rehabilitation after acute coronary syndromes or percutaneous intervention
* Stage III Chronic kidney disease
* Clinically stable with no mobility conditions that preclude safe walking and able to walk
* No contraindications that will prevent measurement of physical ability and exercise capacity including severe arthritis or musculoskeletal disorders
* knee/hip replacement or spinal surgery in past year
* Approved for participation by Principal Investigator
* Not involved in any other research study or undergoing physical therapy
* Able to provide own transportation to study visits and intervention
* Willing to provide written consent
Exclusion Criteria:
* Currently taking fish oil supplements
* Advanced malignancy or other medical condition with life expectancy less than 2 years or undergoing active chemotherapy or radiation therapy
* Oxygen-dependent chronic obstructive pulmonary disease
* Normal kidney function or advanced chronic kidney disease (glomerular filtration rate \< 20 mL/min/1.73 m2, on dialysis or dialysis anticipated within 6 months)
* Mini-mental state examination score of ≤ 21 or previously diagnosed dementia or cognitive impairment limiting ability to participate in rehabilitation and follow study protocols
* Chronic anemia with hemoglobin \<10 gm/dl for males, \<9 gm/dl for females or acute anemia requiring transfusion
* Significant impairment from a prior stroke or other neurologic disease or injury that would preclude participation
* Severe peripheral arterial disease that is the primary limitation to ambulation
* Medical condition that would limit exercise
* High risk for non-adherence as determined by screening evaluation
* Patients who have undergone renal transplantation
* Currently taking bicarbonate supplementation
* Current or recent (within the last 3 months) participation in an exercise program
* Carbon Dioxide level greater than the middle of the normal range i.e. 27mmol/L and thus predisposing to metabolic alkalosis
* Moderate 2+ or greater lower extremity edema
* Active congestive heart failure
* Ejection fraction less than 35%
* Patients using walkers and canes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT02473705
Study Brief:
Protocol Section:
NCT02473705