Hemodialysis-based Interventions to Preserve Cognitive Function

Study Overview
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Brief Summary
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This will be a pilot, single center, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test two interventions (cognitive training and exercise training) against the standard of care.

Detailed Description
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This will be a pilot, single center, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators primary objective is to demonstrate feasibility for the interventions (cognitive training and exercise training) in Aim 1. The investigators will formally test whether whether cognitive training (tablet-based brain games) and exercise training (stationary foot pedal) administered during HD slow cognitive decline as well as improve secondary outcomes (physical function, frailty, and health-related quality of life (HRQOL) as part of Aim 2. The investigators will compare these two interventions against the standard of care. Pre- and post-intervention assessments will be conducted at the dialysis unit by a study coordinator and by research assistants. Participants will be followed for 6 months to assess cognitive decline.

Official Title
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Hemodialysis-based Interventions to Preserve Cognitive Function

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Other: cognitive training
* Other: exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with end stage renal disease and receiving hemodialysis at the DaVita Dialysis Centers located at 409 N. Caroline St., Baltimore, MD will be approached by our study coordinator to determine eligibility. Must be at least 18 years or older at enrollment Must be English speaking Must be willing to participate in research and able to give informed consent Exclusion Criteria: Chronic lung disease requiring oxygen Cerebrovascular disease Musculoskeletal conditions that limit mobility Lower or upper extremity amputation Orthopedic disorders exacerbated by physical activity Decreased mental capacity Dementia (diagnosed)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Participants randomized to the standard of care arm will not receive any intervention. | |
| Experimental: Cognitive training (CT)<br>Participants randomized to the CT arm will be given a tablet with connection to Lumosity®, which is a web-based brain game. Participants will use the tablets to play brain games at each dialysis session. | Other: cognitive training<br>* The investigators will provide participants with tablets to play brain games through Lumosity.<br>|
| Active Comparator: Exercise training (ET)<br>Participants randomized to ET arm will be given a stationary foot peddler. This foot peddler will be situated at a comfortable distance from the dialysis chair so that the patient can comfortably reach the peddler. Participants will use the foot peddlers at each dialysis session. | Other: exercise training<br>* The investigators will provide participants with foot peddlers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function measured using the Modified Mini Mental Status | Cognitive decline assessed as both the change in Modified Mini Mental Status and Trail making Test A and B scores as well as 10% decline in these measures of cognitive function | 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function measured using the Short Physical Performance Battery (SPBB) | SPBB score of <10 considered as physical function impaired | 6 months post-intervention | 
| Fried frailty phenotype | Defined by the presence of 3 or more of the following: slowed walking speed, low physical activity, exhaustion, poor grip strength, and low physical activity. This is a binary outcome | 6 months post-intervention | 
| health-related quality of life (HRQOL) | measured by the Kidney Disease Quality of Life Scale | 6 months post-intervention | 
| Cognitive function | measured using the Trails Making Test A and B | 6 months post-intervention |