Hemodialysis-based Interventions to Preserve Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)
研究概览
简要总结
This is a randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test three interventions cognitive training (CT), exercise training (ET), and combined cognitive and exercise training (CT+ET) relative to standard of care (SC).
详细描述
This will be a two by two factorial, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators primary objective is to determine if receiving cognitive training (tablet-based brain games), exercise training (stationary foot pedal), or combined cognitive and exercise training preserves executive function relative to those with standard of care . The secondary objectives are to compare the rates of end stage renal disease (ESRD)-specific clinical outcomes and patient centered outcomes among those receiving CT, or ET, or CT+ET relative to those in SC. The investigators will formally test whether receiving CT or ET will preserve executive function and receiving combined CT+ET will preserve executive function better than CT or ET alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older at enrollment
- •English speaking
- •within 3 months to 3 years of initiating hemodialysis
- •receiving hemodialysis at participating dialysis centers
排除标准
- •Patients with the following conditions will be excluded:
- •Pregnancy
- •Angina Pectoris
- •Chronic lung disease requiring oxygen
- •Musculoskeletal conditions that limit mobility
- •Upper or lower extremity amputation
- •Orthopedic disorders exacerbated by physical activity
- •Femoral arteriovenous (AV) access
- •Hepatitis B infection
- •Blindness/Legal blindness
- •In addition to conditions outlined above, patients who are currently incarcerated will be excluded from the study.
研究组 & 干预措施
Cognitive training
Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session for 6 months. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.
干预措施: Cognitive training (Other)
Exercise training
Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session for 6 months. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."
干预措施: Exercise training (Other)
Combined cognitive and exercise training
Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).
干预措施: Combined cognitive and exercise training (Other)
Standard of Care
Participants in this arm will receive standard of care
结局指标
主要结局
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)
时间窗: 3 months
Change in executive function between baseline and 3 months as assessed by the Trail Making Test which is comprised of Part A and Part B. Executive function is assessed by the time (seconds) to complete Part B minus the time (seconds) to complete Part A. Needing more time to complete the test indicates worse executive function.
次要结局
- Number of Participants Able to Return to Work(12 months)
- Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey(Baseline and 3 months)
- Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)(Baseline, 3 months)
- Number of Participants Completing Executive Function as Measured by the Stroop Test(3 months)
- Change in Executive Function as Measured by the Digit Symbol Substitution Test(baseline and 3 months)
- Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test(Baseline and 3 months)
- Number of Participants With an Injurious Fall(12 months)
- Number of Participants With a Hospitalizations(12 months)
- Mortality(18 months)
- Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29(Baseline and 3 months)
- Number of Participants With an Amputation(12 months)
- Number of Participants Able to Return to Work(12 months)