Enhancing Physical Function in Older Adults With Chronic Kidney Disease

Официальное название

Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC): A Pilot Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое High-Velocity Resistance Training
  High-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations.
• Поведенческое Attention
  Dedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts.

Первичные конечные точки

• Number of Participants Enrolled [Срок оценки: Month 6]
• Percent of Participant Adherence [Срок оценки: Week 13]
• Percent of Participant Retention [Срок оценки: Week 13]

Вторичные конечные точки (3)

• Change in Short Physical Performance Battery (SPPB) Score [Срок оценки: From baseline to Follow-up (Week 13)]
• Change in Timed Up and Go Test duration [Срок оценки: From baseline to Follow-up (Week 13)]
• Change in lower body peak power [Срок оценки: From baseline to Follow-up (Week 13)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Wake Forest University Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT06738394 · IRB00118658

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗