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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 30 minutes

Awards & highlights

Sym-CKD Trial 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.Check my eligibility

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.See study design

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.

Sym-CKD Trial Eligibility Criteria

Inclusion Criteria

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

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I am a veteran with advanced chronic kidney disease.

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

Sym-CKD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in Functional Sympatholysis

Change in Venoconstriction after Phenylephrine

Change in muscle interstitial pH after handgrip exercise

Sym-CKD 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 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,560 Total Patients Enrolled

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,386 Total Patients Enrolled

Jeanie Park, MDPrincipal Investigator - Emory University

Emory University Hospital, Emory University Hospital Midtown, Select Specialty Hospital-Atlanta

University Of Alabama School Of Medicine (Medical School)

4 Previous Clinical Trials

464 Total Patients Enrolled

Media Library

Sodium Bicarbonate (Buffering Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02411773 — Phase 1

Chronic Kidney Disease Research Study Groups: Control to Exercise (Stretching) plus Sodium Bicarbonate, Control to Exercise (Stretching) plus Placebo, Exercise Training plus Sodium Bicarbonate, Exercise Training plus Placebo, Healthy Control

Chronic Kidney Disease Clinical Trial 2023: Sodium Bicarbonate Highlights & Side Effects. Trial Name: NCT02411773 — Phase 1

Sodium Bicarbonate (Buffering Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02411773 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been prior research conducted on the effects of Stretching/Sodium Bicarbonate?

"Presently, there are 20 investigations into Stretching/Sodium Bicarbonate with one in the final phase of clinical trials. Most studies for this treatment take place in Decatur Georgia although 29 other research sites exist."

Answered by AI

Does this experiment admit participants who are over 35 years of age?

"This clinical trial is only open to patients between 18 and 75 years of age. Those who do not meet the requirements are encouraged to investigate other trials, as there are 43 studies that accept minors and 477 suitable for participants over 65."

Answered by AI

Are any vacancies available for individuals to participate in this experiment?

"According to clinicaltrials.gov, this trial is actively seeking applicants: the initial posting was on May 1st 2015 and it has been revised as recently as September 9th 2022."

Answered by AI

To what extent is this clinical trial enrolling participants?

"Affirmative. Records on clinicaltrials.gov supports the notion that this medical investigation is actively seeking candidates for enrollment, having first been posted on May 1st 2015 and updated most recently as of September 9th 2022. The trial has a capacity of 110 participants from one single site."

Answered by AI

Who is able to register and participate in this medical research?

"This trial seeks 110 volunteers aged between 18 and 75 who suffer from a kidney-related illness. Additionally, applicants must be able to commit to exercising for less than 20 minutes twice weekly and comply with the guidelines of the study protocol."

Answered by AI

What potential risks accompany the practice of stretching and taking sodium bicarbonate?

"Our risk assessment team at Power has determined that the safety of Stretching/Sodium Bicarbonate merits a score of 2. At this point, there is evidence to suggest its safety but none affirming efficacy in humans."

Answered by AI

What circumstances might necessitate the application of Stretching/Sodium Bicarbonate?

"Stretching/Sodium Bicarbonate is frequently prescribed for barbiturate use, but it also has a role in managing helicobacter infections, severe diarrhea, dental plaque and other conditions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sympatholysis in Chronic Kidney Disease

Jeanie Park 2015. "Sympatholysis in Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02411773.

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