Clinical trial NCT02697942: Hemodialysis-based Interventions to Preserve Cognitive Function
Official title: Hemodialysis-based Interventions to Preserve Cognitive Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Cognitive function measured using the Modified Mini Mental Status
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: physical function measured using the Short Physical Performance Battery (SPBB)
timeFrame: 6 months post-intervention
measure: Fried frailty phenotype
timeFrame: 6 months post-intervention
measure: health-related quality of life (HRQOL)
timeFrame: 6 months post-intervention
measure: Cognitive function
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Bond St DaVita Dialysis Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Mara McAdams DeMarco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.