Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC)

Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC): A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Attention; Behavioral: High-Velocity Resistance Training

Detailed Description

Older adults with advanced chronic kidney disease (CKD) commonly exhibit severe impairments in physical function (i.e., inability to perform activities of daily living). Muscle power-the product of muscle force and velocity of contraction- is now widely considered to be a critical determinant of physical function in older adults. Despite this, muscle power has been largely overlooked in the aims and outcomes of exercise interventions for patients with CKD. Several clinical trials have shown that high-velocity resistance training (HVRT) programs consisting of functional movements performed "as fast as possible" with low external loads are safe and effective for improving muscle power and physical function in older adults. However, the available evidence on the effects of exercise interventions designed to improve muscle power in patients with CKD is scarce. This study seeks to determine whether an HVRT intervention in mobility-limited older adults with advanced CKD is feasible, safe, and potentially effective for improving muscle power and physical function.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenna Lauderback; Phone Number: 336-758-3784; Email: epicstudy@wfu.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Principal Investigator: Eliott Arroyo, PhD
      • Contact: Jenna Lauderback; Phone Number: 336-758-3784; Email: epicstudy@wfu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Velocity Resistance Training (HVRT); Those assigned to HVRT will attend three small-group (two to five people) exercise sessions lasting 60-75 minutes per week consisting of upper- and lower-body movements performed with weighted vests, medicine balls, and resistance bands. For all exercises, the concentric phase (muscle-shortening portion) will be performed as quickly as possible while maintaining good form, followed by a 1-second pause and then the eccentric phase (lengthening portion) completed in a slow and controlled fashion. Following completion of the 12-week intervention, all participants will be asked to complete the same baseline tests to assess changes in physical function, body composition, quality of life, and cognitive function outcomes.	Behavioral: High-Velocity Resistance Training; High-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations.
Active Comparator: Control Group; Participants randomized to the attention control group will receive dedicated contact, information, and motivation throughout the course of the intervention via weekly group sessions and informational handouts. Each in-person group meeting will last approximately one hour. These group sessions will take place in a classroom/conference room setting and include information on such topics as blood pressure, reading food labels, healthy eating, and memory. The class will be a PowerPoint presentation with incorporated question/answer, lively discussion, and group-bonding activities. Following completion of the 12-week intervention, all participants will be asked to complete the same baseline tests to assess changes in physical function, body composition, quality of life, and cognitive function outcomes.	Behavioral: Attention; Dedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Enrolled	Number of participants enrolled with a goal of 30.	Month 6
Percent of Participant Adherence	Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)	Week 13
Percent of Participant Retention	Percentage of participants retained at the final follow visit.	Week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Timed Up and Go Test duration	For the timed up-and-go test, the time to complete this task will be measured in seconds. A lower number of seconds to complete the task is indicative of higher physical function.	From baseline to Follow-up (Week 13)
Change in lower body peak power	Leg press peak power will be assessed at 5 relative intensities (40%, 50%, 60%, 70%, and 80% 1-repetition maximum). The highest peak power measurement among those 5 loads will be recorded as peak power. Greater peak power is indicative of greater lower body neuromuscular function.	From baseline to Follow-up (Week 13)
Change in Short Physical Performance Battery (SPPB) Score	The short physical performance battery (SPPB) consists of three tests to assess lower extremity function: a balance test, a gait speed test, and a sit-to-stand test. Performance in each test will be assigned a score ranging from 0 to 4 points, and these scores will be summed to calculate the SPPB score out of 12. A higher SPPB score indicates better function, and scores of 10 or lower are indicative of high risk of disability.	From baseline to Follow-up (Week 13)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Appendicular Lean Mass	Appendicular Lean Mass (kg/m^2) will be measured via dual-energy X-ray absorptiometry (DXA). Higher appendicular lean mass is indicative of improved body composition.	From baseline to Follow-up (Week 13)
Change in isometric leg extension strength	Isometric leg extension strength will be measured with a maximal isometric voluntary contraction of the dominant leg knee extensor muscles using a MicroFET2 hand-held dynamometer. Greater peak force is indicative of greater knee extensor strength.	From baseline to Follow-up (Week 13)
Change in lower body strength	Lower body strength will be measured as the 1-repetition maximum on the leg press, which is the maximum load (kg) that can be moved 1 time only throughout the full range of motion. Increase in leg press 1-repetition maximum is indicative of improved lower body strength.	From baseline to Follow-up (Week 13)
Change in lower body muscle endurance	Lower body muscle endurance will be measured on the leg press as the maximum number of repetitions completed at a load of 70% of baseline 1-repetition maximum with a fixed cadence of 60 bpm. An increase in the number of repetitions completed is indicative of an improvement in lower body muscle endurance.	From baseline to Follow-up (Week 13)
Change in muscle activation	Muscle activation of knee extensors (rectus femoris, vastus medialis, and vastus lateralis) will be assessed by surface electromyography (EMG) during the maximal voluntary contraction (MVC) and during the leg press exercise testing. An increase in the peak EMG root-mean-square amplitude relative to the amplitude during MVC (%MVC) is indicative of greater muscle activation.	From baseline to Follow-up (Week 13)
Change in average daily steps	An ActivPAL 4 triaxial accelerometer will be worn on the midline of the non-dominant thigh for 7 consecutive days prior to the start of the intervention and during the final week of the intervention. An increase in the average number of steps per day is indicative of increased physical activity level.	From baseline to Follow-up (Week 13)
Change in average daily minutes spent sedentary	The average number of minutes spent in sedentary behavior per day will be measured with an ActivPAL 4 triaxial accelerometer. An decrease in the average number of minutes spent in sedentary behavior per day is indicative of a decrease in sedentary activity.	From baseline to Follow-up (Week 13)
Change in average daily minutes spent stepping	The average number of minutes spent stepping per day will be measured with an ActivPAL 4 triaxial accelerometer. An increase in the number of minutes spent stepping per day is indicative of an increase in physical activity.	From baseline to Follow-up (Week 13)
Change in average daily minutes spent stepping above 75 steps per minute and 100 steps per minute	The average number of minutes spent stepping above 75 steps per minute and 100 steps per minute per day will be measured with an ActivPAL 4 triaxial accelerometer. An increase in the number of minutes spent stepping above 75 steps per minute and 100 steps per minute is indicative of an increase in moderate-to-vigorous intensity physical activity.	From baseline to Follow-up (Week 13)
Change in Symbol Digit Coding Test Score	The Symbol Digit Coding Test measures complex information processing accuracy, complex attention, visual-perceptual speed, and information processing speed. The score is the number of correct symbols drawn within a period of 120 seconds. One point is given for each correctly drawn symbol completed within the time limit. The maximum score is 133. High scores indicate higher cognitive functioning.	From baseline to Follow-up (Week 13)
Change in Four-Part Continuous Performance	The 4PCPT test is a four-part test that measures a subject's working memory and sustained attention. Higher scores indicate higher cognitive functioning.	From baseline to Follow-up (Week 13)
Change in Shifting Attention Test Score	SAT test is a measure of ability to shift from one instruction set to another quickly and accurately. Higher scores indicate higher cognitive functioning.	From baseline to Follow-up (Week 13)
Change in Stroop Test Score	Stroop test has three parts. Higher scores indicate higher cognitive functioning.	From baseline to Follow-up (Week 13)
Change in Kidney Disease Quality of Life Short Form (KDQOL-SF) Scores	The KDQOL-SF version 1.3 is a self-report measure developed for individuals with kidney disease. It includes 43 kidney-disease targeted items as well as 36 items that provide a generic core and an overall health rating item. 0-100 possible range, with higher scores always reflecting better quality of life.	From baseline to Follow-up (Week 13)

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Eliott Arroyo, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: older adults; kidney disease; resistance training
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Renal Insufficiency, Chronic; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests
• Other Study ID Numbers: IRB00118658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No