Hemodialysis-based Interventions to Preserve Cognitive Function

Kidney Failure, Chronic Clinical Trial

Official title:

Hemodialysis-based Interventions to Preserve Cognitive Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02697942
• Other study ID #: IRB00006466
• Status: Terminated
• Phase: N/A
• First received: February 9, 2016
• Last updated: April 17, 2018
• Start date: February 2016
• Est. completion date: November 20, 2017

Study information

• Verified date: April 2018
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: November 20, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Other:
• cognitive training
The investigators will provide participants with tablets to play brain games through Lumosity.
• exercise training
The investigators will provide participants with foot peddlers.

Locations

Country	Name	City	State
United States	Bond St DaVita Dialysis Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	physical function measured using the Short Physical Performance Battery (SPBB)	SPBB score of <10 considered as physical function impaired	6 months post-intervention
Secondary	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
Secondary	health-related quality of life (HRQOL)	measured by the Kidney Disease Quality of Life Scale	6 months post-intervention
Secondary	Cognitive function	measured using the Trails Making Test A and B	6 months post-intervention