Hemodialysis-based Interventions to Preserve Cognitive Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Interventions Made to Preserve Cognitive Function

NCT03616535

ESRD

TERMINATED NA

Comparison of Dialysis Therapies on Cognitive Function

NCT00597103

End Stage Renal Disease Chronic Kidney Disease

COMPLETED

Evaluation of the Effect of Cooled Haemodialysis on Cognitive Function in Patients Suffering With End-stage KD

NCT03645733

Cognitive Impairment

UNKNOWN NA

Cognitive and Functional Status and Dialysis Outcomes in Older Hemodialysis Patients

NCT00739843

Dementia Cognition End-stage Renal Disease

TERMINATED

Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

NCT03874117

Hemodialysis Kidney Failure, Chronic

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Failure, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Cognitive training (CT)

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.

Group Type EXPERIMENTAL

cognitive training

Intervention Type OTHER

The investigators will provide participants with tablets to play brain games through Lumosity.

Exercise training (ET)

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.

Group Type ACTIVE_COMPARATOR

exercise training

Intervention Type OTHER

The investigators will provide participants with foot peddlers.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cognitive training

The investigators will provide participants with tablets to play brain games through Lumosity.

Intervention Type OTHER

exercise training

The investigators will provide participants with foot peddlers.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No