Interventions Made to Preserve Cognitive Function

NCT03616535, Not applicable, Terminated, Johns Hopkins University; results first posted 2025-04-11

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Interventions Made to Preserve Cognitive Function	ClinicalTrials.gov
NCT number	NCT03616535	ClinicalTrials.gov
Status	Terminated	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	130 participants, actual	ClinicalTrials.gov
Lead sponsor	Johns Hopkins University	ClinicalTrials.gov
Conditions	ESRD	ClinicalTrials.gov
Interventions	Cognitive training, Exercise training, Combined cognitive and exercise training	ClinicalTrials.gov
First posted	2018-08-06	ClinicalTrials.gov
Last updated	2025-07-16	ClinicalTrials.gov
Results first posted	2025-04-11	ClinicalTrials.gov

Registered outcomes 12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)	3 months	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 (seconds) to complete Part B minus the time (seconds) to complete Part A. Needing more time to complete the test indicates worse executive function.	ClinicalTrials.gov
Secondary	Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)	Baseline, 3 months	Change in global cognitive function at 3-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 range is 0-30 points, and a score of 26 or above is considered normal.	ClinicalTrials.gov
Secondary	Number of Participants Completing Executive Function as Measured by the Stroop Test	3 months	Number completing the Stroop test of executive function at 3 months of interventions. The Stroop test asks participants to view two conflicting pieces of information, specifically the word itself and the color of the ink it's printed in. Participants are asked to name the color of the ink used to print words, rather than reading the words themselves.	ClinicalTrials.gov
Secondary	Change in Executive Function as Measured by the Digit Symbol Substitution Test	baseline and 3 months	Change in executive function at 3 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. Total possible score ranges from a minimum of 0 to a maximum of 90 points. Higher scores represent better outcomes.	ClinicalTrials.gov
Secondary	Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test	Baseline and 3 months	Change in lower extremity function at 3 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.	ClinicalTrials.gov
Secondary	Number of Participants With an Injurious Fall	12 months	Number of participants with an injurious falls resulting in a medical encounter during the 6 months of interventions and for 6 months after the interventions	ClinicalTrials.gov
Secondary	Number of Participants With a Hospitalizations	12 months	The number of participants with a hospitalizations during the 6 months of interventions and 6 months after the interventions	ClinicalTrials.gov
Secondary	Mortality	18 months	Mortality will be ascertained within the 6 months of the intervention and 1 year after the intervention (1.5 years total).	ClinicalTrials.gov
Secondary	Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey	Baseline and 3 months	Change in kidney disease-specific physical and mental quality of life at 3 months. Using a single the question from the KDQOL: In general, would you say your health is \_\_\_ ? It is reported on a 5-point score: 1, poor; 2, fair; 3, good; 4, very good; 5, excellent. Higher is better. While the score of KDQOL ranges from 1 to 5 points, we are measuring the 3-month change in this score. Therefore, the change could range from -4 to 4 points.	ClinicalTrials.gov
Secondary	Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29	Baseline and 3 months	Change in Patient-centered Outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 The change in PROMIS-29 score at 3 months is reported. Scores range from 0-140; higher scores are better.	ClinicalTrials.gov
Secondary	Number of Participants With an Amputation	12 months	The number of participants with an amputation 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	ClinicalTrials.gov
Secondary	Number of Participants Able to Return to Work	12 months	The number of participants able to return to work during the 6 months of interventions and 6 months after interventions.	ClinicalTrials.gov

Outcomes 12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)	3 months	Due to COVID-19 shutdowns, the trial was terminated early by the DSMB. All participants with available TMT A/B at baseline and 3 months of follow-up were analyzed.	seconds	MEAN	ClinicalTrials.gov
SECONDARY	Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)	Baseline, 3 months	Participants with an available MoCA at baseline and 3-month follow-up were included in this analysis.	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Number of Participants Completing Executive Function as Measured by the Stroop Test	3 months	Participants with an available Stroop test at 3-month follow-up were included in this analysis.	participants	NUMBER	ClinicalTrials.gov
SECONDARY	Change in Executive Function as Measured by the Digit Symbol Substitution Test	baseline and 3 months	Participants with an available Digit Symbol Substitution Test at baseline and 3-month follow-up were included in this analysis.	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test	Baseline and 3 months	Participants with an available SPPB at baseline and 3-month follow-up were included in this analysis.	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Number of Participants With an Injurious Fall	12 months		Participants	COUNT_OF_PARTICIPANTS	ClinicalTrials.gov
SECONDARY	Number of Participants With a Hospitalizations	12 months		Participants	COUNT_OF_PARTICIPANTS	ClinicalTrials.gov
SECONDARY	Mortality	18 months		Participants	COUNT_OF_PARTICIPANTS	ClinicalTrials.gov
SECONDARY	Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey	Baseline and 3 months	Participants with available KDQOL at baseline and 3-month follow-up were included in this analysis.	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29	Baseline and 3 months	Only participants with available PROMIS-29 at baseline and 3 months were included.	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Number of Participants With an Amputation	12 months		Participants	COUNT_OF_PARTICIPANTS	ClinicalTrials.gov
SECONDARY	Number of Participants Able to Return to Work	12 months	Among those who were unemployed or on leave of absence at baseline	Participants	COUNT_OF_PARTICIPANTS	ClinicalTrials.gov

Results by group 48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units	Source
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)	Cognitive Training	20.4	Standard Deviation 54.9	seconds	ClinicalTrials.gov
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)	Exercise Training	-0.8	Standard Deviation 82	seconds	ClinicalTrials.gov
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)	Combined Cognitive and Exercise Training	-5.6	Standard Deviation 101.7	seconds	ClinicalTrials.gov
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)	Standard of Care	5.7	Standard Deviation 53.2	seconds	ClinicalTrials.gov
Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)	Cognitive Training	-0.1	Standard Deviation 2.9	score on a scale	ClinicalTrials.gov
Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)	Exercise Training	0.1	Standard Deviation 2.1	score on a scale	ClinicalTrials.gov
Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)	Combined Cognitive and Exercise Training	1.5	Standard Deviation 3.1	score on a scale	ClinicalTrials.gov
Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)	Standard of Care	-0.6	Standard Deviation 3.3	score on a scale	ClinicalTrials.gov
Number of Participants Completing Executive Function as Measured by the Stroop Test	Cognitive Training	16		participants	ClinicalTrials.gov
Number of Participants Completing Executive Function as Measured by the Stroop Test	Exercise Training	14		participants	ClinicalTrials.gov
Number of Participants Completing Executive Function as Measured by the Stroop Test	Combined Cognitive and Exercise Training	19		participants	ClinicalTrials.gov
Number of Participants Completing Executive Function as Measured by the Stroop Test	Standard of Care	13		participants	ClinicalTrials.gov
Change in Executive Function as Measured by the Digit Symbol Substitution Test	Cognitive Training	3.6	Standard Deviation 12.8	score on a scale	ClinicalTrials.gov
Change in Executive Function as Measured by the Digit Symbol Substitution Test	Exercise Training	6.4	Standard Deviation 15.6	score on a scale	ClinicalTrials.gov
Change in Executive Function as Measured by the Digit Symbol Substitution Test	Combined Cognitive and Exercise Training	2.0	Standard Deviation 18.9	score on a scale	ClinicalTrials.gov
Change in Executive Function as Measured by the Digit Symbol Substitution Test	Standard of Care	.7	Standard Deviation 20	score on a scale	ClinicalTrials.gov
Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test	Cognitive Training	-1.5	Standard Deviation 3.9	score on a scale	ClinicalTrials.gov
Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test	Exercise Training	-1.7	Standard Deviation 3.8	score on a scale	ClinicalTrials.gov
Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test	Combined Cognitive and Exercise Training	-0.1	Standard Deviation 2.8	score on a scale	ClinicalTrials.gov
Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test	Standard of Care	0.1	Standard Deviation 1.8	score on a scale	ClinicalTrials.gov

Participant flow 12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Cognitive Training	31	ClinicalTrials.gov
Overall Study	STARTED	Exercise Training	29	ClinicalTrials.gov
Overall Study	STARTED	Combined Cognitive and Exercise Training	35	ClinicalTrials.gov
Overall Study	STARTED	Standard of Care	26	ClinicalTrials.gov
Overall Study	COMPLETED	Cognitive Training	24	ClinicalTrials.gov
Overall Study	COMPLETED	Exercise Training	23	ClinicalTrials.gov
Overall Study	COMPLETED	Combined Cognitive and Exercise Training	27	ClinicalTrials.gov
Overall Study	COMPLETED	Standard of Care	21	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Cognitive Training	7	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Exercise Training	6	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Combined Cognitive and Exercise Training	8	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Standard of Care	5	ClinicalTrials.gov

Adverse events 28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Source
other	Cramp	Musculoskeletal and connective tissue disorders	Cognitive Training	14	31	ClinicalTrials.gov
other	Cramp	Musculoskeletal and connective tissue disorders	Exercise Training	13	29	ClinicalTrials.gov
other	Cramp	Musculoskeletal and connective tissue disorders	Combined Cognitive and Exercise Training	15	35	ClinicalTrials.gov
other	Cramp	Musculoskeletal and connective tissue disorders	Standard of Care	7	26	ClinicalTrials.gov
other	Hypotension	General disorders	Cognitive Training	7	31	ClinicalTrials.gov
other	Hypotension	General disorders	Exercise Training	11	29	ClinicalTrials.gov
other	Hypotension	General disorders	Combined Cognitive and Exercise Training	17	35	ClinicalTrials.gov
other	Hypotension	General disorders	Standard of Care	0	26	ClinicalTrials.gov
other	Hypertension	General disorders	Cognitive Training	12	31	ClinicalTrials.gov
other	Hypertension	General disorders	Exercise Training	10	29	ClinicalTrials.gov
other	Hypertension	General disorders	Combined Cognitive and Exercise Training	10	35	ClinicalTrials.gov
other	Hypertension	General disorders	Standard of Care	4	26	ClinicalTrials.gov
other	Elevated heart rate	Cardiac disorders	Cognitive Training	0	31	ClinicalTrials.gov
other	Elevated heart rate	Cardiac disorders	Exercise Training	3	29	ClinicalTrials.gov
other	Elevated heart rate	Cardiac disorders	Combined Cognitive and Exercise Training	3	35	ClinicalTrials.gov
other	Elevated heart rate	Cardiac disorders	Standard of Care	0	26	ClinicalTrials.gov
other	headache	General disorders	Cognitive Training	6	31	ClinicalTrials.gov
other	headache	General disorders	Exercise Training	7	29	ClinicalTrials.gov
other	headache	General disorders	Combined Cognitive and Exercise Training	13	35	ClinicalTrials.gov
other	headache	General disorders	Standard of Care	4	26	ClinicalTrials.gov

Adverse event totals 12

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Cognitive Training	6	31	ClinicalTrials.gov
Total, all-cause mortality	Exercise Training	4	29	ClinicalTrials.gov
Total, all-cause mortality	Combined Cognitive and Exercise Training	3	35	ClinicalTrials.gov
Total, all-cause mortality	Standard of Care	4	26	ClinicalTrials.gov
Total, other adverse events	Cognitive Training	24	31	ClinicalTrials.gov
Total, other adverse events	Exercise Training	21	29	ClinicalTrials.gov
Total, other adverse events	Combined Cognitive and Exercise Training	28	35	ClinicalTrials.gov
Total, other adverse events	Standard of Care	12	26	ClinicalTrials.gov
Total, serious adverse events	Cognitive Training	6	31	ClinicalTrials.gov
Total, serious adverse events	Exercise Training	1	29	ClinicalTrials.gov
Total, serious adverse events	Combined Cognitive and Exercise Training	4	35	ClinicalTrials.gov
Total, serious adverse events	Standard of Care	0	26	ClinicalTrials.gov

Papers 2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32883245	DERIVED	PubMed
35018639	DERIVED	PubMed

Grants 1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R01DK114074	Hemodialysis-based interventions to preserve cognitive function	MCADAMS DEMARCO, MARA A.	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2018 to 2022	NIH RePORTER

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Trail Making Test A	Primary outcome	ConductCognition
Trail Making Test B	Primary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition
Symbol Coding	Secondary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)