Pathways to Improving Functional Capacity in Older Patients With Chronic Kidney Disease and Cardiovascular Disease

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Chronic Kidney Disease, Cardiovascular Disease

In brief

The purpose of this research study is to study the effect of fish oil and bicarbonate (baking soda) on exercise. In this study fish oil, bicarbonate or both will be compared to placebo to see if study participants increase exercise capacity.

Key facts

Study ID

NCT02473705

Run by

Wake Forest University Health Sciences

People needed

0

Starts

2016-01-01

Expected to finish

2017-06-01

Last updated by the study team

2017-11-07

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest Baptist Health Cardiac Rehab — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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