NCT02697942

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

February 9, 2016

Last Update Submit

April 17, 2018

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • physical function measured using the Short Physical Performance Battery (SPBB)

    6 months post-intervention

  • Fried frailty phenotype

    6 months post-intervention

  • health-related quality of life (HRQOL)

    6 months post-intervention

  • Cognitive function

    6 months post-intervention

Study Arms (3)

Standard of care

NO INTERVENTION

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

Cognitive training (CT)

EXPERIMENTAL

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

Exercise training (ET)

ACTIVE COMPARATOR

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

Interventions

cognitive trainingOTHER

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

Cognitive training (CT)
exercise trainingOTHER

The investigators will provide participants with foot peddlers.

Exercise training (ET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bond St DaVita Dialysis Center

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

  • 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.

    PMID: 35018639DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Cognitive TrainingExercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mara McAdams DeMarco, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

March 3, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2017

Study Completion

November 20, 2017

Last Updated

April 19, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)