← Back to Search

Buffering Agent

Exercise for Chronic Kidney Disease (Sym-CKD Trial)

Phase 1

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

Veterans with Stages III and IV Chronic Kidney Disease (CKD)

Veterans 18-75 years old, without kidney disease, as study controls

Must not have

Uncontrolled hypertension with blood pressure (BP) greater than 170/100 mmHg

Treatment with central alpha agonists (clonidine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 30 minutes

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is studying how well exercise training works in patients with CKD.

Who is the study for?

This trial is for veterans aged 18-75 with Stage III or IV Chronic Kidney Disease who exercise less than 40 minutes per week. It's also open to similar-aged veterans without kidney disease as controls. Participants must be able to follow the study plan and ride a stationary bike, but can't join if they have severe CKD, certain blood chemistry imbalances, drug/alcohol abuse issues, diabetic neuropathy, serious diseases affecting survival chances, severe anemia or heart problems.

What is being tested?

The study aims to understand why patients with chronic kidney disease struggle with physical activity and experience high blood pressure during it. It tests how stretching exercises compare against no exercise (control), the effects of sodium bicarbonate supplementation versus placebo, and the benefits of regular exercise training.

What are the potential side effects?

Possible side effects from participating in this trial could include muscle soreness or injury from exercising. Sodium bicarbonate may cause digestive discomfort like bloating or stomach pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a veteran with advanced chronic kidney disease.

Select...

I am a veteran aged 18-75 without kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My blood pressure is not higher than 170/100 mmHg.

Select...

I am currently taking medication like clonidine.

Select...

I have heart failure or my heart pumps less blood than normal.

Select...

I have heart problems confirmed by tests or my medical history.

Select...

I am currently taking MAOI medications.

Select...

My kidney function is severely reduced.

Select...

I have nerve damage due to diabetes.

Select...

My hemoglobin level is below 10 g/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in muscle interstitial pH after exercise/stretching training

Change in muscle oxygenation after exercise/stretching training

Change in venoconstriction after exercise/stretching training

Secondary study objectives

Change in Functional Sympatholysis

Change in Venoconstriction after Phenylephrine

Change in muscle interstitial pH after handgrip exercise

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

5Treatment groups

Active Control

Placebo Group

Group I: Control to Exercise (Stretching) plus Sodium BicarbonateActive Control2 Interventions

Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each stretching session three times a week.

Group II: Exercise Training plus Sodium BicarbonateActive Control2 Interventions

Subjects with CKD will undergo exercise training on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each exercise session three times a week.

Group III: Exercise Training plus PlaceboActive Control2 Interventions

Subjects with CKD will undergo exercise training on a stationary bicycle,for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week.

Group IV: Healthy ControlActive Control1 Intervention

Healthy subjects without CKD will not receive any interventions.

Group V: Control to Exercise (Stretching) plus PlaceboPlacebo Group2 Interventions

Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week.

0 / 10Eligibility criteria met