Enhancing Physical Function in Older Adults With Chronic Kidney Disease

NCT06738394 | Recruiting

• 1 other identifier: IRB00118658
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Determine whether implementing an HVRT intervention is feasible and safe for mobility-limited older adults with advanced CKD.
2. 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

Keywords

kidney disease; resistance training; older adults

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in Short Physical Performance Battery (SPPB) Score

  From baseline to Follow-up (Week 13)

• Change in Timed Up and Go Test duration

  From baseline to Follow-up (Week 13)

• Change in lower body peak power

  From baseline to Follow-up (Week 13)

Other Outcomes (14)

• Change in Appendicular Lean Mass

  From baseline to Follow-up (Week 13)

• Change in isometric leg extension strength

  From baseline to Follow-up (Week 13)

• Change in lower body strength

  From baseline to Follow-up (Week 13)

Study Arms (2)

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.

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.

Behavioral: Attention

Interventions

High-Velocity Resistance Training BEHAVIORAL

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

High-Velocity Resistance Training (HVRT)

Attention BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Eliott Arroyo, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Lauderback

CONTACT

336-758-3784; epicstudy@wfu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)