Interventions Made to Preserve Cognitive Function (IMPCT)

Johns Hopkins University

Status: Terminated

Conditions: ESRD

Treatments: Other: Combined cognitive and exercise training; Other: Cognitive training; Other: Exercise training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03616535

IRB00152858

R01DK114074 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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130 participants in 4 patient groups

Cognitive training

Active Comparator group

Description:

Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session for 6 months. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.

Treatment:

Other: Cognitive training

Exercise training

Active Comparator group

Description:

Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session for 6 months. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."

Treatment:

Other: Exercise training

Combined cognitive and exercise training

Active Comparator group

Description:

Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).

Treatment:

Other: Combined cognitive and exercise training

Standard of Care

No Intervention group

Description:

Participants in this arm will receive standard of care