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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
The investigators will provide participants with tablets to play brain games.
The investigators will provide participants with foot peddlers.
The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
New York University Langone Health
New York, New York, United States
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)
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.
Time frame: 3 months
Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
Change in global cognitive function at 3-months of interventions as measured by the Montreal Cognitive Assessment (MoCA). It is a brief 30 question test that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual construction skills, conceptual thinking, calculations, and orientation. Total possible score range is 0-30 points, and a score of 26 or above is considered normal.
Time frame: Baseline, 3 months
Number of Participants Completing Executive Function as Measured by the Stroop Test
Number completing the Stroop test of executive function at 3 months of interventions. The Stroop test asks participants to view two conflicting pieces of information, specifically the word itself and the color of the ink it's printed in. Participants are asked to name the color of the ink used to print words, rather than reading the words themselves.
Time frame: 3 months
Change in Executive Function as Measured by the Digit Symbol Substitution Test
Change in executive function at 3 months of interventions as measure by the Digit Symbol Substitution Test. This test evaluates the speed and working memory components of executive function. It involves a key consisting of the numbers 1-9, each paired with a unique, easy-to--draw symbol such as a "V", "+" or "\>". Below the key are a series of the numbers 1-9 in random order and repeated several times. The participant is allowed 90 seconds to fill in the corresponding symbol for each number. This task requires the individual to visually scan the answer key provided at the top of the test and then write the correct symbol by each number as quickly as possible. The correct number of symbols written within 90 seconds is measured. Total possible score ranges from a minimum of 0 to a maximum of 90 points. Higher scores represent better outcomes.
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Time frame: baseline and 3 months
Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test
Change in lower extremity function at 3 months of interventions using the SPPB test. The SPPB is an objective assessment tool for evaluating lower extremity functioning This test is a performance-based assessment comprised of 3 tasks: 1) repeated chair stands, 2) standing balance, and 3) a 4-meter usual paced walk in those with and without a walking aid (meters/second). Participants receive a score of 0 for a task if they were unable to complete the task; otherwise, they receive scores of 1-4 based on population-based norms. The scores of the three tasks are summed to create the SPPB score. The SPPB score ranges from 0 to 12, with lower scores indicating poorer function.
Time frame: Baseline and 3 months
Number of Participants With an Injurious Fall
Number of participants with an injurious falls resulting in a medical encounter during the 6 months of interventions and for 6 months after the interventions
Time frame: 12 months
Number of Participants With a Hospitalizations
The number of participants with a hospitalizations during the 6 months of interventions and 6 months after the interventions
Time frame: 12 months
Mortality
Mortality will be ascertained within the 6 months of the intervention and 1 year after the intervention (1.5 years total).
Time frame: 18 months
Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey
Change in kidney disease-specific physical and mental quality of life at 3 months. Using a single the question from the KDQOL: In general, would you say your health is \_\_\_ ? It is reported on a 5-point score: 1, poor; 2, fair; 3, good; 4, very good; 5, excellent. Higher is better. While the score of KDQOL ranges from 1 to 5 points, we are measuring the 3-month change in this score. Therefore, the change could range from -4 to 4 points.
Time frame: Baseline and 3 months
Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Change in Patient-centered Outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 The change in PROMIS-29 score at 3 months is reported. Scores range from 0-140; higher scores are better.
Time frame: Baseline and 3 months
Number of Participants With an Amputation
The number of participants with an amputation during the 6 months of interventions and 6 months after interventions. This information will be either self-reported by the participant or abstracted from the medical records to see if the interventions are associated with amputations
Time frame: 12 months
Number of Participants Able to Return to Work
The number of participants able to return to work during the 6 months of interventions and 6 months after interventions.
Time frame: 12 months