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Hemodialysis-based Interventions to Preserve Cognitive Function

Primary Purpose

Kidney Failure, Chronic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive training
exercise training
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Bond St DaVita Dialysis Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Standard of care

Cognitive training (CT)

Exercise training (ET)

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

physical function measured using the Short Physical Performance Battery (SPBB)
SPBB score of <10 considered as physical function impaired
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
health-related quality of life (HRQOL)
measured by the Kidney Disease Quality of Life Scale
Cognitive function
measured using the Trails Making Test A and B

Full Information

First Posted
February 9, 2016
Last Updated
April 17, 2018
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT02697942
Brief Title
Hemodialysis-based Interventions to Preserve Cognitive Function
Official Title
Hemodialysis-based Interventions to Preserve Cognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
closure of dialysis center where study was being conducted
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Participants randomized to the standard of care arm will not receive any intervention.
Arm Title
Cognitive training (CT)
Arm Type
Experimental
Arm 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.
Arm Title
Exercise training (ET)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
cognitive training
Intervention Description
The investigators will provide participants with tablets to play brain games through Lumosity.
Intervention Type
Other
Intervention Name(s)
exercise training
Intervention Description
The investigators will provide participants with foot peddlers.
Primary Outcome Measure Information:
Title
Cognitive function measured using the Modified Mini Mental Status
Description
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
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
physical function measured using the Short Physical Performance Battery (SPBB)
Description
SPBB score of <10 considered as physical function impaired
Time Frame
6 months post-intervention
Title
Fried frailty phenotype
Description
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
Time Frame
6 months post-intervention
Title
health-related quality of life (HRQOL)
Description
measured by the Kidney Disease Quality of Life Scale
Time Frame
6 months post-intervention
Title
Cognitive function
Description
measured using the Trails Making Test A and B
Time Frame
6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara McAdams DeMarco, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bond St DaVita Dialysis Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35018639
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.
Results Reference
derived

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Hemodialysis-based Interventions to Preserve Cognitive Function

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