Your session is about to expire
← Back to Search
Behavioral Intervention
Exercise for Chronic Kidney Disease
Phase 2
Recruiting
Led By Jeanie Park, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with CKD or persons without kidney disease as matched study controls
CKD patients must have stable renal function (no greater than a decline of estimated glomerular filtration (eGFR) of 1 cc/min/1.73 m2 per month over the prior 6 months) and baseline serum bicarbonate 22-24 mmol/L
Must not have
Class 3 obesity (BMI>40)
Current use of immunosuppressive medications (including but not limited to steroids, cyclophosphamide, calcineurin inhibitors, mycophenolate, biologics, methotrexate, etc)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Awards & highlights
Summary
This trial aims to help people with chronic kidney disease improve their ability to exercise. It uses regular physical activity and a substance similar to baking soda to make it easier for their muscles to get enough blood during exercise.
Who is the study for?
This trial is for sedentary adults with stable chronic kidney disease (CKD) or healthy individuals as controls. CKD participants should have a steady kidney function, normal serum bicarbonate levels, and may have hypertension. Excluded are those with severe obesity, uncontrolled high blood pressure, recent surgery, pregnancy plans, certain heart conditions or metal implants that affect MRI scanning.
What is being tested?
The study explores how exercise affects people with CKD compared to healthy controls. It tests whether exercise training or sodium bicarbonate supplementation can improve the body's response to physical activity in CKD patients versus a placebo group.
What are the potential side effects?
Potential side effects from the interventions could include muscle soreness or fatigue from exercise training and digestive discomfort from sodium bicarbonate supplementation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I either have chronic kidney disease or I do not have any kidney disease.
Select...
My kidney function is stable and my blood's bicarbonate level is within the normal range.
Select...
I have high blood pressure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My BMI is over 40.
Select...
I am currently taking medications that suppress my immune system.
Select...
My heart pumps less blood than normal.
Select...
I have nerve damage due to diabetes.
Select...
I am currently taking bicarbonate.
Select...
I have symptoms of heart failure.
Select...
I cannot stop taking my α- and β-blocker medications.
Select...
My blood pressure is not higher than 170/100 mm Hg.
Select...
My kidney function is severely reduced.
Select...
I have peripheral arterial disease.
Select...
I have heart problems that show up on tests or in my medical history.
Select...
I am currently taking medication like clonidine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Exercise Capacity
Secondary study objectives
Change in Diastolic Blood Pressure
Change in Exercise Pressor Reflex
Change in Interleukin 6 (IL-6)
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Exercise Training plus Sodium BicarbonateExperimental Treatment2 Interventions
Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take 650-1300 mg of sodium bicarbonate twice daily.
Group II: Exercise Training plus PlaceboActive Control2 Interventions
Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take placebo tablets to match 650-1300 mg of sodium bicarbonate twice daily.
Group III: Healthy controlActive Control1 Intervention
Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Training
2011
Completed Phase 3
~1470
Sodium Bicarbonate
2015
Completed Phase 4
~2060
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Exercise therapy for Chronic Kidney Disease (CKD) patients works by enhancing cardiovascular and muscular function. It improves blood flow, reduces blood pressure, and increases muscle strength and endurance.
These benefits are crucial for CKD patients, who often face reduced exercise capacity, cardiovascular issues, and muscle wasting. By addressing these problems, exercise therapy can help slow disease progression and improve the quality of life for CKD patients.
Uremic Sarcopenia: Clinical Evidence and Basic Experimental Approach.
Uremic Sarcopenia: Clinical Evidence and Basic Experimental Approach.
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,688 Previous Clinical Trials
2,602,759 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,908 Previous Clinical Trials
47,758,217 Total Patients Enrolled
Jeanie Park, MDPrincipal InvestigatorEmory University
4 Previous Clinical Trials
418 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called metabolic alkalosis.Your blood has low levels of hemoglobin, which is less than 10 grams per deciliter.My BMI is over 40.I have not had a heart attack or stroke in the last six months.I either have chronic kidney disease or I do not have any kidney disease.Currently using drugs or drinking alcohol excessivelyYou don't regularly exercise, meaning you exercise for less than 20 minutes, twice a week.I do not have any serious illnesses that could affect my survival.I am currently taking medications that suppress my immune system.My heart pumps less blood than normal.Your blood pressure is lower than 100/50 mm Hg.I have nerve damage due to diabetes.My kidney function is stable and my blood's bicarbonate level is within the normal range.I am currently taking bicarbonate.I have symptoms of heart failure.I cannot stop taking my α- and β-blocker medications.You have an arteriovenous (AV) fistula or graft.My blood pressure is not higher than 170/100 mm Hg.I have had surgery in the last 3 months.My kidney function is severely reduced.I have peripheral arterial disease.I have heart problems that show up on tests or in my medical history.I am currently taking medication like clonidine.Your blood potassium levels are too low or too high.You cannot ride a stationary bicycle.I have high blood pressure.
Share this study with friends
Copy Link
Messenger