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Enhancing Physical Function in Older Adults With Chronic Kidney Disease

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06738394
Acronym
EPIC
Enrollment
30
Registered
2024-12-17
Start date
2025-07-31
Completion date
2027-07-01
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

kidney disease, resistance training, older adults

Brief summary

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.

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.

Interventions

High-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations.

BEHAVIORALAttention

Dedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants EnrolledMonth 6Number of participants enrolled with a goal of 30.
Percent of Participant AdherenceWeek 13Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)
Percent of Participant RetentionWeek 13Percentage of participants retained at the final follow visit.

Secondary

MeasureTime frameDescription
Change in Short Physical Performance Battery (SPPB) ScoreFrom baseline to Follow-up (Week 13)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.
Change in Timed Up and Go Test durationFrom baseline to Follow-up (Week 13)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.
Change in lower body peak powerFrom baseline to Follow-up (Week 13)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.

Countries

United States

Contacts

CONTACTRodrigo Lion
epicstudy@wfu.edu336-758-3784
PRINCIPAL_INVESTIGATOREliott Arroyo, PhD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026