About this 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:
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic kidney disease stages 3-5
Capacity to complete physical exercise
Lives within 20 miles of Wake Forest Reynolda Campus
Fluent English speaker
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
High-Velocity Resistance Training
BehavioralHigh-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations.
Attention
BehavioralDedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants Enrolled
Number of participants enrolled with a goal of 30.
Percent of Participant Adherence
Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)
Percent of Participant Retention
Percentage of participants retained at the final follow visit.
Secondary outcomes
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.
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.
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.
Other outcomes
Change in Appendicular Lean Mass
Appendicular Lean Mass (kg/m\^2) will be measured via dual-energy X-ray absorptiometry (DXA). Higher appendicular lean mass is indicative of improved body composition.
Change in isometric leg extension strength
Isometric leg extension strength will be measured with a maximal isometric voluntary contraction of the dominant leg knee extensor muscles using a MicroFET2 hand-held dynamometer. Greater peak force is indicative of greater knee extensor strength.
Change in lower body strength
Lower body strength will be measured as the 1-repetition maximum on the leg press, which is the maximum load (kg) that can be moved 1 time only throughout the full range of motion. Increase in leg press 1-repetition maximum is indicative of improved lower body strength.
Change in lower body muscle endurance
Lower body muscle endurance will be measured on the leg press as the maximum number of repetitions completed at a load of 70% of baseline 1-repetition maximum with a fixed cadence of 60 bpm. An increase in the number of repetitions completed is indicative of an improvement in lower body muscle endurance.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.