Chronic Kidney DiseasesEPICNCT06738394
Enhancing Physical Function in Older Adults With Chronic Kidney Disease
A study testing High-Velocity Resistance Training and Attention in people with Chronic Kidney Diseases, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- High-Velocity Resistance Training and Attention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Jenna Lauderback, 336-758-3784, epicstudy@wfu.edu
Eliott Arroyo, PhD
About this study
Official title: 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:
- Determine whether implementing an HVRT intervention is feasible and safe for mobility-limited older adults with advanced CKD.
- Collect preliminary data on the efficacy of HVRT for improving muscle power and physical function in mobility-limited older adults with advanced CKD.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- High-Velocity Resistance Training, Attention
- Keywords
- kidney disease, resistance training, older adults
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Velocity Resistance TrainingBehavioural
High-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations.
AttentionBehavioural
Dedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts.
| Study group | Role | What they receive |
|---|---|---|
| High-Velocity Resistance Training (HVRT) | Experimental | 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. Receives: Behavioral: High-Velocity Resistance Training |
| Control Group | Active comparator | 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. Receives: Behavioral: Attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled
Number of participants enrolled with a goal of 30.
Measured: Month 6
Percent of Participant Adherence
Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)
Measured: Week 13
Percent of Participant Retention
Percentage of participants retained at the final follow visit.
Measured: Week 13
Secondary outcomes (3)
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.
Measured: From baseline to Follow-up (Week 13)
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.
Measured: 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.
Measured: From baseline to Follow-up (Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start31 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliott Arroyo, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738394
- Sponsor's protocol ID
- IRB00118658
- Acronym
- EPIC
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06738394
- Acronym / sponsor ID
- EPIC / IRB00118658
- Conditions
- Chronic Kidney Diseases
- Keywords
- kidney disease, resistance training, older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine whether implementing an HVRT intervention is feasible and safe for mobility-limited older adults with advanced CKD.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Velocity Resistance Training (HVRT) | Experimental | Behavioral: High-Velocity Resistance TrainingThose 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. |
| Control Group | Active comparator | Behavioral: AttentionParticipants 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Velocity Resistance TrainingHigh-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations. | Behavioural | High-Velocity Resistance Training (HVRT) |
| AttentionDedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts. | Behavioural | Control Group |
Primary outcome
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.
3 secondary outcomes
Change in Short Physical Performance Battery (SPPB) Score
Time frame: From baseline to Follow-up (Week 13)
Change in Timed Up and Go Test duration
Time frame: From baseline to Follow-up (Week 13)
Change in lower body peak power
Time frame: From baseline to Follow-up (Week 13)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eliott Arroyo, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Velocity Resistance Training and Attention in people with Chronic Kidney Diseases, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Lion (336-758-3784, epicstudy@wfu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Enrolled (time frame: Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.