Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants Enrolled
研究概览
简要总结
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:
- Determine whether implementing an HVRT intervention is feasible and safe for mobility-limited older adults with advanced CKD.
- Collect preliminary data on the efficacy of HVRT for improving muscle power and physical function in mobility-limited older adults with advanced CKD.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High-Velocity Resistance Training (HVRT)
Those assigned to HVRT will attend three small-group (two to five people) exercise sessions lasting 60-75 minutes per week consisting of upper- and lower-body movements performed with weighted vests, medicine balls, and resistance bands. For all exercises, the concentric phase (muscle-shortening portion) will be performed as quickly as possible while maintaining good form, followed by a 1-second pause and then the eccentric phase (lengthening portion) completed in a slow and controlled fashion. Following completion of the 12-week intervention, all participants will be asked to complete the same baseline tests to assess changes in physical function, body composition, quality of life, and cognitive function outcomes.
干预措施: High-Velocity Resistance Training (Behavioral)
Control Group
Participants randomized to the attention control group will receive dedicated contact, information, and motivation throughout the course of the intervention via weekly group sessions and informational handouts. Each in-person group meeting will last approximately one hour. These group sessions will take place in a classroom/conference room setting and include information on such topics as blood pressure, reading food labels, healthy eating, and memory. The class will be a PowerPoint presentation with incorporated question/answer, lively discussion, and group-bonding activities. Following completion of the 12-week intervention, all participants will be asked to complete the same baseline tests to assess changes in physical function, body composition, quality of life, and cognitive function outcomes.
干预措施: Attention (Behavioral)
结局指标
主要结局
Number of Participants Enrolled
时间窗: Month 6
Number of participants enrolled with a goal of 30.
Percent of Participant Adherence
时间窗: Week 13
Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)
Percent of Participant Retention
时间窗: Week 13
Percentage of participants retained at the final follow visit.
次要结局
- Change in Short Physical Performance Battery (SPPB) Score(From baseline to Follow-up (Week 13))
- Change in Timed Up and Go Test duration(From baseline to Follow-up (Week 13))
- Change in lower body peak power(From baseline to Follow-up (Week 13))
- Change in Short Physical Performance Battery (SPPB) Score(From baseline to Follow-up (Week 13))
- Change in Timed Up and Go Test duration(From baseline to Follow-up (Week 13))
- Change in lower body peak power(From baseline to Follow-up (Week 13))