Interventions Made to Preserve Cognitive Function

ESRD Clinical Trial

— IMPCT  

Official title:

Hemodialysis-based Interventions to Preserve Cognitive Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03616535
• Other study ID #: IRB00152858
• Secondary ID: R01DK114074
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: December 8, 2024

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test three interventions cognitive training (CT), exercise training (ET), and combined cognitive and exercise training (CT+ET) relative to standard of care (SC).

Description:

This will be a two by two factorial, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators primary objective is to determine if receiving cognitive training (tablet-based brain games), exercise training (stationary foot pedal), or combined cognitive and exercise training preserves executive function relative to those with standard of care . The secondary objectives are to compare the rates of end stage renal disease (ESRD)-specific clinical outcomes and patient centered outcomes among those receiving CT, or ET, or CT+ET relative to those in SC. The investigators will formally test whether receiving CT or ET will preserve executive function and receiving combined CT+ET will preserve executive function better than CT or ET alone.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: December 8, 2024
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older at enrollment

• English speaking

• within 3 months to 3 years of initiating hemodialysis

• receiving hemodialysis at participating dialysis centers

Exclusion Criteria: Patients with the following conditions will be excluded:

• Pregnancy

• Angina Pectoris

• Chronic lung disease requiring oxygen

• Musculoskeletal conditions that limit mobility

• Upper or lower extremity amputation

• Orthopedic disorders exacerbated by physical activity

• Femoral arteriovenous (AV) access

• Hepatitis B infection

• Blindness/Legal blindness

In addition to conditions outlined above, patients who are currently incarcerated will be excluded from the study.

Related Conditions & MeSH terms

• ESRD

Intervention

Other:
• Cognitive training
The investigators will provide participants with tablets to play brain games.
• Exercise training
The investigators will provide participants with foot peddlers.
• Combined cognitive and exercise training
The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	New York University Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in executive function as assessed by the Trail Making Test	Change in executive function between baseline and 3 months as assessed by the Trail Making Test which is comprised of Part A and Part B. Executive function is assessed by the time (minutes) to complete Part B minus the time (minutes) to complete Part A. Needing more time to complete the test indicates worse executive function.	3 months
Secondary	Change in Global Cognitive Function as measured by the Montreal Cognitive Assessment (MoCA)	Change in global cognitive function at 3-months and 6 months of interventions as measured by the Montreal Cognitive Assessment (MoCA). It is a brief 30 question test that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual construction skills, conceptual thinking, calculations, and orientation. Total possible score is 30 points and a score of 26 or above is considered normal.	3 months and 6 months
Secondary	Change in Executive function as measured by the Stroop test	Change in executive function at 3 months and 6 months of interventions as measured by the Stroop Test. The Stroop test is a screening test for cognitive function test and evaluates the inhibitory control of executive function. It is a measure of the ability of the brain to sort out distracting or unnecessary information from the meaningful tasks. It involves reading the name of a color printed in a different color ink. The time ratio of color-word interference and color only tasks will be calculated.	3 months and 6 months
Secondary	Change in Executive function as measured by the Digit Symbol Substitution Test	Change in executive function at 3 months and 6 months of interventions as measure by the Digit Symbol Substitution Test. This test evaluates the speed and working memory components of executive function. It involves a key consisting of the numbers 1-9, each paired with a unique, easy-to--draw symbol such as a "V", "+" or ">". Below the key are a series of the numbers 1-9 in random order and repeated several times. The participant is allowed 90 seconds to fill in the corresponding symbol for each number. This task requires the individual to visually scan the answer key provided at the top of the test and then write the correct symbol by each number as quickly as possible. The correct number of symbols written within 90 seconds is measured.	3 months and 6 months
Secondary	Change in Physical function as measured by the Short Physical Performance Battery (SPPB) test	Change in lower extremity function at 3 months and 6 months of interventions using the SPPB test. The SPPB is an objective assessment tool for evaluating lower extremity functioning This test is a performance-based assessment comprised of 3 tasks: 1) repeated chair stands, 2) standing balance, and 3) a 4-meter usual paced walk in those with and without a walking aid (meters/second). Participants receive a score of 0 for a task if they were unable to complete the task; otherwise, they receive scores of 1-4 based on population-based norms. The scores of the three tasks are summed to create the SPPB score. The SPPB score ranges from 0 to 12, with lower scores indicating poorer function.	3 months and 6 months
Secondary	Number of Falls	Number of injurious falls resulting in a medical encounter during the 6 months of interventions and for 6 months after the interventions	12 months
Secondary	Number of Hospitalizations	The number of hospitalizations parameterized as both the number of hospital admissions and number of days hospitalized during the 6 months of interventions and 6 months after the interventions	12 months
Secondary	Mortality	Mortality will be captured through Center for Medicare and Medicaid Services (CMS) death notification or the National Death Index. Mortality will be ascertained within the 6 months of the intervention and 1 year after the intervention (1.5 years total).	18 months
Secondary	Change in Patient-centered Outcomes as measured by the Kidney Disease Quality of Life (KDQOL) Survey	Change in kidney disease-specific physical and mental quality of life at 3 months and 6 months of interventions. The KDQOL s a kidney disease-specific measure of how kidney disease is impacting a participant's quality of life. It is a 36-item survey with 3 subscales including physical and mental health-related quality of life, and kidney disease-specific HRQOL. Each subscale is scored 0 to 100 with higher scores indicating better HRQOL.	3 months and 6 months
Secondary	Change in Patient-centered Outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29	Change in the participants' physical, mental, and social health status at 3 months and 6 months of interventions. PROMIS-29 is a health-related quality of life survey which assesses each of the 7 PROMIS domains with 4 questions. Norm-based scores have been calculated for each domain on the PROMIS measures. High scores represent more of the domain being measured. Thus, on symptom-oriented domains of PROMIS-29 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent worse symptomatology. On the function-oriented domains (physical functioning and social role) higher scores represent better functioning.	3 months and 6 months
Secondary	Number of Amputations	The number of amputations during the 6 months of interventions and 6 months after interventions. This information will be either self-reported by the participant or abstracted from the medical records to see if the interventions are associated with amputations	12 months
Secondary	Number of Participants Able to Return to Work	The number of participants able to return to work during the 6 months of interventions and 6 months after interventions.	12 months