Clinical trial NCT06738394: Enhancing Physical Function in Older Adults With Chronic Kidney Disease
Official title: Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: kidney disease
resistance training
older adults
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Enrolled
timeFrame: Month 6
measure: Percent of Participant Adherence
timeFrame: Week 13
measure: Percent of Participant Retention
timeFrame: Week 13
Secondary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) Score
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in Timed Up and Go Test duration
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in lower body peak power
timeFrame: From baseline to Follow-up (Week 13)
Other outcomes:
measure: Change in Appendicular Lean Mass
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in isometric leg extension strength
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in lower body strength
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in lower body muscle endurance
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in muscle activation
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in average daily steps
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in average daily minutes spent sedentary
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in average daily minutes spent stepping
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in average daily minutes spent stepping above 75 steps per minute and 100 steps per minute
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in Symbol Digit Coding Test Score
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in Four-Part Continuous Performance
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in Shifting Attention Test Score
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in Stroop Test Score
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in Gradual Continuous Performance Test (CPT) Score
timeFrame: From baseline to Follow-up (Week 13)
measure: Change in Kidney Disease Quality of Life Short Form (KDQOL-SF) Scores
timeFrame: From baseline to Follow-up (Week 13)
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Eliott Arroyo, PhD
role: PRINCIPAL_INVESTIGATOR
References: