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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Awards & highlights
Study Summary
This trial looks into how exercise can help people with CKD improve their health.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Exercise Capacity
Secondary outcome measures
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
~1440
Sodium Bicarbonate
2015
Completed Phase 4
~1610
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,540 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,851,968 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I a viable candidate to partake in this research?
"This clinical trial is in search of 156 participants who suffer from chronic kidney disease and are within the age range of 40 to 75."
Answered by AI
Is Exercise Training combined with Sodium Bicarbonate an effective and safe option for individuals?
"Exercise Training plus Sodium Bicarbonate is deemed a moderately safe practice, rating at 2 on our scale of 1 to 3. This evaluation was made as we are in the second phase of clinical trials and have not yet gathered enough data to confirm efficacy."
Answered by AI
Is inclusion in this trial restricted to those aged sixty or below?
"This clinical trial calls for individuals aged 40 to 75, with 46 studies targeting those below 18 and 498 focusing on the elderly."
Answered by AI
Are there any vacancies for this clinical investigation?
"Data housed on clinicaltrials.gov indicates that this research is actively recruiting, with the initial posting having occurred on November 11th 2022 and the most recent edit having been made June 25th 2023."
Answered by AI
How many participants are included in this clinical experiment?
"Affirmative. According to the clinicaltrials.gov portal, this research study has been open since November 11th 2022 and is still recruiting participants today. A total of 156 individuals are needed between 2 sites for successful completion."
Answered by AI
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