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Combination Exercise for Chronic Kidney Disease

Phase 2

Recruiting

Led By Jared M. Gollie, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Control group will include ambulatory individuals without clinical evidence of kidney disease (defined by eGRF >60 ml/min per 1.73m2) within the last 12-months

Ambulatory (with or without a gait aid), 50 years of age or older diagnosed with chronic kidney disease (CKD) stages 3 & 4 predialysis (as defined by eGFR 59-15 ml/min per 1.73m2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6 and 12

Awards & highlights

Study Summary

This trial will test whether combination exercise is more effective than aerobic exercise alone in improving health outcomes for Veterans with chronic kidney disease.

Who is the study for?

This trial is for English-speaking Veterans over 50 with chronic kidney disease stages 3 & 4 who can walk (with or without help). It's not for those with acute kidney issues in the past year, non-ambulatory individuals, people planning to move from the DC area within a year, or those with uncontrolled heart or musculoskeletal conditions.Check my eligibility

What is being tested?

The study tests combination exercise (flywheel resistance plus aerobic) on fatigue in Veterans with chronic kidney disease. The goal is to see if this exercise can improve muscle function and overall health compared to a control group without kidney disease.See study design

What are the potential side effects?

While specific side effects are not listed, exercises like these could potentially cause muscle soreness, joint pain, or fatigue. Participants will be monitored for any adverse effects related to their condition.

Eligibility Criteria

Inclusion Criteria

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

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I can walk and have no signs of kidney disease in the past year.

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I am 50 or older, can walk (with or without help), and have stage 3 or 4 CKD not on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 and 12 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 knee extensor fatigability

change in muscle blood flow

change in perceived fatigability

Secondary outcome measures

change in Sit-to-Stand

change in muscle Quality

change in rate of torque development

Other outcome measures

change in health-related quality of life

Body Weight Changes

change in interleukin 6 (IL-6) and tumor necrosis factor alpha

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Combination ExerciseExperimental Treatment1 Intervention

Flywheel resistance exercise plus aerobic exercise

Group II: Standard-of-careActive Control1 Intervention

Participants will maintain standard-of-care and current activity levels during the course of the study.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,154 Total Patients Enrolled

Jared M. Gollie, PhDPrincipal InvestigatorWashington DC VA Medical Center, Washington, DC

1 Previous Clinical Trials

52 Total Patients Enrolled

Media Library

Combination Exercise (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04397159 — Phase 2

Chronic Kidney Disease Research Study Groups: Combination Exercise, Standard-of-care

Chronic Kidney Disease Clinical Trial 2023: Combination Exercise Highlights & Side Effects. Trial Name: NCT04397159 — Phase 2

Combination Exercise (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04397159 — Phase 2

Frequently Asked Questions

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

What is the desired number of participants for this experiment?

"Yes, the information available on clinicaltrials.gov indicates that this trial is still recruiting patients. This particular study was first posted on June 1st, 2022 and last updated two weeks later on June 14th. As of right now, they are looking for 30 more participants at a single site."

Answered by AI

Could you explain who would be able to sign up for this medical research?

"Up to 30 patients who are currently suffering from chronic kidney disease, and between the ages of 50 and 85, will be accepted into this study. Furthermore, it is a requirement that these individuals also match the following description: The control group must be composed of ambulatory people without any clinical evidence of renal impairment (as defined by eGRF >60 ml/min per 1.73m2) in the last 12 months."

Answered by AI

Are there any risks associated with partaking in this physical activity regiment?

"This combination exercise program is in Phase 2 of clinical trials, meaning that while there is some data supporting its safety, none yet exists to show that it is effective."

Answered by AI

Can new participants still sign up for this research?

"From what is stated onclinicaltrials.gov, this clinical trial is still searching for eligible patients. This study was originally posted on 6/1/2022 and the information was updated as recently as 6/14/2022."

Answered by AI