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Behavioral Intervention

Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC Trial)

N/A

Waitlist Available

Led By Eliott Arroyo, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Chronic kidney disease stage 4-5

* Capacity to complete physical exercise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for older adults with advanced chronic kidney disease (stages 4-5) who have limited mobility. Participants should be interested in improving their muscle power and physical function.

What is being tested?

The study tests a 12-week high-velocity resistance training program against weekly group sessions on healthy living. The goal is to see if the exercise program is doable, safe, and effective at boosting muscle strength and helping participants move better.

What are the potential side effects?

Since this trial involves exercise, potential side effects may include muscle soreness or injury. However, as it's designed for those with limited mobility and CKD stages 4-5, safety measures will be in place to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Enrolled

Percent of Participant Adherence

Percent of Participant Retention

Secondary study objectives

Change in Short Physical Performance Battery (SPPB) Score

Change in Timed Up and Go Test duration

Change in lower body peak power

Other study objectives

Change in Appendicular Lean Mass

Change in Four-Part Continuous Performance

Change in Gradual Continuous Performance Test (CPT) Score

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High-Velocity Resistance Training (HVRT)Experimental Treatment1 Intervention

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.

Group II: Control GroupActive Control1 Intervention

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.

0 / 7Eligibility criteria met