NCT06738394 · Wake Forest University Health Sciences
Enhancing Physical Function in Older Adults With Chronic Kidney Disease
(EPIC)
What this study is about
The goal of this pilot randomly assigned controlled trial is to examine the feasibility and safety of a 12-week high-velocity resistance training (HVRT) intervention in older adults with chronic kidney disease (CKD) stages 4-5 and to generate preliminary data to inform a future study investigating the effectiveness of HVRT for improving muscle power and physical function.
View original scientific description
The goal of this pilot randomized controlled trial is to examine the feasibility and safety of a 12-week high-velocity resistance training (HVRT) intervention in older adults with chronic kidney disease (CKD) stages 4-5 and to generate preliminary data to inform a future study investigating the efficacy of HVRT for improving muscle power and physical function. Researchers will compare HVRT to an attention control condition consisting of weekly group sessions covering topics on healthy lifestyle. This study seeks to: 1. Determine whether implementing an HVRT intervention is feasible and safe for mobility-limited older adults with advanced CKD. 2. Collect preliminary data on the efficacy of HVRT for improving muscle power and physical function in mobility-limited older adults with advanced CKD.
Interventions
BEHAVIORAL
High-Velocity Resistance Training
High-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations.
BEHAVIORAL
Attention
Dedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts.
Primary outcome measures
Number of Participants Enrolled
Time frame: Month 6
Number of participants enrolled with a goal of 30.
Percent of Participant Adherence
Time frame: Week 13
Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)
Percent of Participant Retention
Time frame: Week 13
Percentage of participants retained at the final follow visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Chronic kidney disease stages 3-5
- Capacity to complete physical exercise
- Lives within 20 miles of Wake Forest Reynolda Campus
- Fluent English speaker
- Does not plan to travel outside of home area for an extended period of time during study
- Willing to be randomized to either intervention group
Exclusion criteria
- Receiving renal replacement therapy (e.g. hemodialysis, peritoneal dialysis) or anticipated to start renal replacement therapy in the next 6 months
- Dependent on a wheelchair
- Current participation in a resistance training program
- Joint replacement or orthopedic surgery in the previous 6 months or planning to have surgery in the next 6 months months
- Absolute contraindications to exercise testing according to ACSM: Acute myocardial infarction within the past 6 months Ongoing unstable angina Uncontrolled cardiac arrhythmia with hemodynamic compromise Active endocarditis Symptomatic severe aortic stenosis Decompensated heart failure Acute pulmonary embolism, pulmonary infarction, or deep venous thrombosis Acute myocarditis or pericarditis Acute aortic dissection
- Parkinson's disease
- Respiratory disease requiring oxygen
- Cancer requiring treatment
- Currently receiving physical therapy or cardiopulmonary rehabilitation
- Type I or insulin dependent Type II Diabetes
- Scoring below 32 points on the Telephone Interview for Cognitive Status (TICS)
- Site PI/Study Clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence
Where
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 31, 2025 · Source of record for eligibility and locations