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Behavioural Intervention

Exercise Program for Chronic Kidney Disease

N/A
Waitlist Available
Led By Devika Nair, MD
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
Participants classified as pre-frail per Fried Frailty phenotype due to slowness (time taken to walk 15 feet is greater than 6 seconds) in Aim 1
Participants who report 'YES' to any of the following: 'For health or physical reasons, do you have difficulty in walking a mile (5-6 blocks)?', 'If no, have you changed the way you walk half a mile (5-6 blocks) because of underlying health problems?', 'For health or physical reasons, do you have difficulty in climbing 1 flight of stairs (10 steps)?', 'If no, have you changed the way you climb 1 flight of stairs (10 steps) because of health problems?'
Must not have
Myocardial infarction or unstable angina within the prior six months based on electronic medical record review or self-report
Dyspnea and/or chest pain at rest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months, 6 months, and 7 months
Awards & highlights

Summary

This trial tests a 16-week exercise program for Veterans with advanced kidney disease to see if it is safe and tolerable.

Who is the study for?
This trial is for Veterans with advanced chronic kidney disease who experience difficulty walking or climbing stairs, and are considered pre-frail. They must be cleared by their doctor to participate, not wheelchair-bound, living outside long-term care facilities, not facing terminal illness or major surgery soon, and not enrolled in other exercise programs.
What is being tested?
The study tests a 16-week physical activity and power training program's tolerability among participants. It involves two groups: one receiving the Pro-social Power Training Activity and another undergoing an Attention Control condition as a comparison.
What are the potential side effects?
Since this is a physical activity program designed for individuals with chronic kidney disease, potential side effects may include muscle soreness, fatigue, joint pain or discomfort during or after exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am considered pre-frail because it takes me more than 6 seconds to walk 15 feet.
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I have trouble walking a mile or climbing stairs due to health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a heart attack or unstable chest pain in the last six months.
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I experience shortness of breath or chest pain without doing any activity.
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I rely on a wheelchair to move around.
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I expect to undergo dialysis or a kidney transplant soon.
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I have had a stroke or mini-stroke in the last six months.
Select...
I have been diagnosed with the most severe level of heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months, 6 months, and 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months, 6 months, and 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility, as measured by a numerical percentage of all participants who consented out of those eligible
Feasibility, as measured by a qualitative description of participants' reasons for declining
Feasibility, as measured by the questionnaire, the Feasibility of Intervention Measure
Other study objectives
Acceptability, as measured by participants' qualitative descriptions of reasons for intervention enjoyability, if applicable
Acceptability, as measured by the questionnaire, the Acceptability of Intervention Measure
Adverse events, as measured by the the number of participants who report adverse events from the Common Terminology Criteria for Adverse Events, v5.0
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Power training and monitored physical activityExperimental Treatment1 Intervention
This is a 16-week power-training and physical activity-focused intervention that contains in-center and at-home components and motivational coaching. Participants will meet 2-3 times per week for the in-center power training. Participants will also be asked to wear accelerometers at home in order for their physical activity frequency to be measured.
Group II: Attention controlActive Control1 Intervention
This will be the attention control arm that will involve receipt of a physical activity education booklet, use of an accelerometer, and weekly check-in calls. No power training or motivational coaching will be delivered.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,040 Total Patients Enrolled
Devika Nair, MDPrincipal InvestigatorTennessee Valley Healthcare System Nashville Campus, Nashville, TN
~20 spots leftby Apr 2027
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