Hemodialysis-based Interventions to Preserve Cognitive Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ESRD
- Sponsor
- Johns Hopkins University
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older at enrollment
- •English speaking
- •within 3 months to 3 years of initiating hemodialysis
- •receiving hemodialysis at participating dialysis centers
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)
Time Frame: 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.
Secondary Outcomes
- 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 Kidney Disease Quality of Life (KDQOL) Survey(Baseline and 3 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)