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Combination Exercise for Chronic Kidney Disease

N/A
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)
Must not have
Adults diagnosed with acute renal failure/injury within the last 12-months
Non-ambulatory individuals
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 and 12
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I was diagnosed with acute kidney failure in the last year.
Select...
I cannot walk by myself.
Select...
I do not have joint pain that would stop me from safely following the study's requirements.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in knee extensor fatigability
change in muscle blood flow
change in perceived fatigability
Secondary study objectives
change in Sit-to-Stand
change in muscle Quality
change in rate of torque development
Other study objectives
change in health-related quality of life
Body Weight Changes
change in interleukin 6 (IL-6) and tumor necrosis factor alpha
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,779 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 — N/A
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 — N/A
Combination Exercise (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04397159 — N/A
~10 spots leftby Apr 2026
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