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NCT Number: NCT06738394

Enhancing Physical Function in Older Adults With Chronic Kidney Disease

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.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Eliott Arroyo, PhD

PRINCIPAL_INVESTIGATOR

Jenna Lauderback

CONTACT

[email protected]

336-758-3784

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Velocity Resistance Training

Behavioral

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

ATTENTION

Behavioral

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

Primary outcomes

  1. Number of Participants Enrolled

    Time frame: Month 6

    Number of participants enrolled with a goal of 30.

  2. Percent of Participant Adherence

    Time frame: Week 13

    Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)

  3. Percent of Participant Retention

    Time frame: Week 13

    Percentage of participants retained at the final follow visit.

Secondary outcomes

  1. Change in Short Physical Performance Battery (SPPB) Score

    Time frame: From 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.

  2. Change in Timed Up and Go Test duration

    Time frame: From 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.

  3. Change in lower body peak power

    Time frame: From 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.

Other outcomes

  1. Change in Appendicular Lean Mass

    Time frame: From baseline to Follow-up (Week 13)

    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.

  2. Change in isometric leg extension strength

    Time frame: From baseline to Follow-up (Week 13)

    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.

  3. Change in lower body strength

    Time frame: From baseline to Follow-up (Week 13)

    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.

  4. Change in lower body muscle endurance

    Time frame: From baseline to Follow-up (Week 13)

    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.

  5. Change in muscle activation

    Time frame: From baseline to Follow-up (Week 13)

    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.

  6. Change in average daily steps

    Time frame: From baseline to Follow-up (Week 13)

    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.

  7. Change in average daily minutes spent sedentary

    Time frame: From baseline to Follow-up (Week 13)

    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.

  8. Change in average daily minutes spent stepping

    Time frame: From baseline to Follow-up (Week 13)

    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.

  9. Change in average daily minutes spent stepping above 75 steps per minute and 100 steps per minute

    Time frame: From baseline to Follow-up (Week 13)

    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.

  10. Change in Symbol Digit Coding Test Score

    Time frame: From baseline to Follow-up (Week 13)

    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.

  11. Change in Four-Part Continuous Performance

    Time frame: From baseline to Follow-up (Week 13)

    The 4PCPT test is a four-part test that measures a subject's working memory and sustained attention. Higher scores indicate higher cognitive functioning.

  12. Change in Shifting Attention Test Score

    Time frame: From baseline to Follow-up (Week 13)

    SAT test is a measure of ability to shift from one instruction set to another quickly and accurately. Higher scores indicate higher cognitive functioning.

  13. Change in Stroop Test Score

    Time frame: From baseline to Follow-up (Week 13)

    Stroop test has three parts. Higher scores indicate higher cognitive functioning.

  14. Change in Kidney Disease Quality of Life Short Form (KDQOL-SF) Scores

    Time frame: From baseline to Follow-up (Week 13)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenna Lauderback

CONTACT

[email protected]

336-758-3784

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: EPIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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