Kidney Failure, Chronic
Conditions
Brief summary
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
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.
Interventions
OTHERexercise training
The investigators will provide participants with foot peddlers.
OTHERcognitive training
The investigators will provide participants with tablets to play brain games through Lumosity.
Sponsors
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function measured using the Modified Mini Mental Status | 6 months post-intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physical function measured using the Short Physical Performance Battery (SPBB) | 6 months post-intervention | SPBB score of \<10 considered as physical function impaired |
| Fried frailty phenotype | 6 months post-intervention | 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 |
| health-related quality of life (HRQOL) | 6 months post-intervention | measured by the Kidney Disease Quality of Life Scale |
| Cognitive function | 6 months post-intervention | measured using the Trails Making Test A and B |
Countries
United States
Outcome results
None listed