Enhancing Physical Function in Older Adults With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Velocity Resistance Training, Attention.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases. Basic parameters: 65 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC): A Pilot Randomized Controlled Trial
Overview
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.
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.
Interventions
- Behavioral High-Velocity Resistance Training
High-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations. - Behavioral Attention
Dedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts.
Primary outcome measures
- Number of Participants Enrolled [Time frame: Month 6]
- Percent of Participant Adherence [Time frame: Week 13]
- Percent of Participant Retention [Time frame: Week 13]
Secondary outcome measures (3)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT06738394 · IRB00118658