Hemodialysis-based Interventions to Preserve Cognitive Function

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.

Study Overview

• Status: Terminated
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Other: cognitive training; Other: exercise training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Bond St DaVita Dialysis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; Participants randomized to the standard of care arm will not receive any intervention.
Experimental: 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.	Other: cognitive training; The investigators will provide participants with tablets to play brain games through Lumosity.
Active Comparator: 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.	Other: exercise training; The investigators will provide participants with foot peddlers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function measured using the Modified Mini Mental Status	Cognitive decline assessed as both the change in Modified Mini Mental Status and Trail making Test A and B scores as well as 10% decline in these measures of cognitive function	6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical function measured using the Short Physical Performance Battery (SPBB)	SPBB score of <10 considered as physical function impaired	6 months post-intervention
Fried frailty phenotype	Defined by the presence of 3 or more of the following: slowed walking speed, low physical activity, exhaustion, poor grip strength, and low physical activity. This is a binary outcome	6 months post-intervention
health-related quality of life (HRQOL)	measured by the Kidney Disease Quality of Life Scale	6 months post-intervention
Cognitive function	measured using the Trails Making Test A and B	6 months post-intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Mara McAdams DeMarco, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: IRB00006466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO