Recruiting

HVRT

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06738394

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

High-Velocity Resistance Training

Attention

Study Details

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.

Conditions

Chronic Kidney Diseases

Study ID

NCT06738394

Start date

Jul 31, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

High-Velocity Resistance Training

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

Attention

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

Primary outcome measure

  • Number of Participants Enrolled [ Time Frame: Month 6 ]
  • Percent of Participant Adherence [ Time Frame: Week 13 ]
  • Percent of Participant Retention [ Time Frame: Week 13 ]

Central Contacts and Locations

Central contacts

Rodrigo Lion

336-758-3784epicstudy@wfu.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Jenna Lauderback

336-758-3784epicstudy@wfu.edu

Principal Investigator:

Eliott Arroyo, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • kidney disease
  • resistance training
  • older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.