Hemodialysis-based Interventions to Preserve Cognitive Function

Johns Hopkins Bloomberg School of Public Health

Status: Terminated

Conditions: Kidney Failure, Chronic

Treatments: Other: cognitive training; Other: exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02697942

IRB00006466

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Standard of care

No Intervention group

Description:

Participants randomized to the standard of care arm will not receive any intervention.

Cognitive training (CT)

Experimental group

Description:

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.

Treatment:

Other: cognitive training

Exercise training (ET)

Active Comparator group

Description:

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.

Treatment:

Other: exercise training