Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Change in Peak Aerobic Capacity
研究概览
简要总结
Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance in 120 older adults with CKD not requiring dialysis. The results of this study will be essential for demonstrating the effectiveness of exercise in improving function and ultimately preventing disability in this high-risk population of older adults.
详细描述
This is a parallel-group randomized controlled trial comparing 12 months of aerobic and resistance exercise training vs. health education (attention control) on neurocognitive and physical performance among community-dwelling older adults (age >55) and CKD stage 3b and 4. Co-primary outcomes are change in physical performance (including aerobic capacity and submaximal walking) and neurocogntive performance (including executive functions).
Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training will occur thrice weekly at a dedicated research exercise center and will be supervised by exercise specialists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 3-4 Chronic kidney disease (estimated Glomerular Filtration Rate 15-45)
- •Age 60 to 85
- •English Speaking
排除标准
- •Dementia or cognitive impairment
- •Renal transplant
- •New York Heart Association class 3-4 heart failure
- •Severe Chronic Lung Disease
- •Unstable angina or coronary revascularization within the last 3 months
- •Orthopedic problems that would preclude aerobic exercise training
- •Known, untreated infection
- •Disabling arthritis
- •Uncontrolled arrhythmia
- •More than 14 alcoholic drinks per week
研究组 & 干预措施
Aerobic exercise
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
干预措施: Aerobic exercise training (Behavioral)
Health Education
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Change in Peak Aerobic Capacity
时间窗: Baseline, 6 months, 12 months
VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity
Change in 6 Minute Walk
时间窗: Baseline, 6 months, 12 months
Distance walked in 6 minutes - greater distance represents higher function
次要结局
- Change in Physical Function(Baseline, 6 months, 12 months)
- Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)(Baseline, 6 months, 12 months)
研究者
Stephen Seliger
Associate Professor of Medicine at University of Maryland
University of Maryland, Baltimore