Hemodialysis-based Interventions to Preserve Cognitive Function
- Conditions
- Kidney Failure, Chronic
- Interventions
- Other: cognitive trainingOther: exercise training
- Registration Number
- NCT02697942
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
-
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive training (CT) cognitive training 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. Exercise training (ET) exercise training 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Bond St DaVita Dialysis Center
🇺🇸Baltimore, Maryland, United States