Enhancing Physical Function in Older Adults With Chronic Kidney Disease

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT06738394
• Lead Sponsor: Wake Forest University Health Sciences

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.

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Study Start: 2025-05
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Chronic kidney disease stage 4-5
• 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
• Short physical performance battery score of 9 or higher

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 walking device
• 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
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Enrolled	Month 6	Number of participants enrolled with a goal of 30.
Percent of Participant Adherence	Week 13	Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)
Percent of Participant Retention	Week 13	Percentage of participants retained at the final follow visit.

Secondary Outcome Measures

Name	Time	Method
Change in Short Physical Performance Battery (SPPB) Score	From baseline to Follow-up (Week 13)	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 ranging from 4 to 9 are indicative of high risk of disability.
Change in Timed Up and Go Test duration	From baseline to Follow-up (Week 13)	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	From baseline to Follow-up (Week 13)	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States