Clinical trial NCT03616535: Interventions Made to Preserve Cognitive Function
Official title: Hemodialysis-based Interventions to Preserve Cognitive Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ESRD
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-08-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

In addition to conditions outlined above, patients who are currently incarcerated will be excluded from the study.

Primary outcomes:
measure: Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)
timeFrame: 3 months
Secondary outcomes:
measure: Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: 3 months and 6 months
measure: Change in Executive Function as Measured by the Stroop Test
timeFrame: 3 months and 6 months
measure: Change in Executive Function as Measured by the Digit Symbol Substitution Test
timeFrame: 3 months and 6 months
measure: Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test
timeFrame: 3 months and 6 months
measure: Number of Falls
timeFrame: 12 months
measure: Number of Hospitalizations
timeFrame: 12 months
measure: Mortality
timeFrame: 18 months
measure: Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey
timeFrame: 3 months and 6 months
measure: Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29
timeFrame: 3 months and 6 months
measure: Number of Amputations
timeFrame: 12 months
measure: Number of Participants Able to Return to Work
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: New York
country: United States
facility: New York University Langone Health
state: New York
Study officials:
affiliation: Johns Hopkins University
name: Aarti Mathur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
citation: McAdams-DeMarco MA, Chu NM, Steckel M, Kunwar S, Gonzalez Fernandez M, Carlson MC, Fine DM, Appel LJ, Diener-West M, Segev DL. Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function. BMC Nephrol. 2020 Sep 3;21(1):383. doi: 10.1186/s12882-020-02041-y.