Trial Outcomes & Findings for Exercise and Cognitive Retraining to Improve Cognition in Heart Failure. (NCT NCT02151266)

NCT ID: NCT02151266

Last Updated: 2021-01-25

Results Overview

List Learning (0-40), List Recall (0-10), and List Recognition (0-20) sections from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) are used to assess Verbal memory.The range of scores for each section are in parentheses. Higher scores reflect better verbal memory. Scores are averaged for a total Verbal memory score, then converted to Z-score. Z-scores are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group. For interpretive purposes, a z-score has a mean of 0 and a standard deviation of 1. This means that an individual who has a z-score of 1.5 is performing one and a half standard deviations above the group to which he/she is compared.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 69 participants
• Primary outcome timeframe: Baseline, 3 months, 6 months
• Results posted on: 2021-01-25

Participant Flow

Participant milestones

Measure	Exercise and Cognitive Retraining Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Overall Study STARTED	19	29	21
Overall Study COMPLETED	11	14	14
Overall Study NOT COMPLETED	8	15	7

Reasons for withdrawal

Measure	Exercise and Cognitive Retraining Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Overall Study Lost to Follow-up	1	4	1
Overall Study Did NOT receive intervention	3	6	2
Overall Study Not able to exercise	4	5	4

Baseline Characteristics

Exercise and Cognitive Retraining to Improve Cognition in Heart Failure.

Baseline characteristics by cohort

Measure	Exercise and Cognitive Retraining n=19 Participants Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only n=29 Participants Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility n=21 Participants Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility	Total n=69 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 11 • n=5 Participants	60 years STANDARD_DEVIATION 10 • n=7 Participants	63 years STANDARD_DEVIATION 9 • n=5 Participants	61 years STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	17 Participants n=7 Participants	8 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	16 Participants n=7 Participants	9 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	19 participants n=5 Participants	29 participants n=7 Participants	21 participants n=5 Participants	69 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months

List Learning (0-40), List Recall (0-10), and List Recognition (0-20) sections from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) are used to assess Verbal memory.The range of scores for each section are in parentheses. Higher scores reflect better verbal memory. Scores are averaged for a total Verbal memory score, then converted to Z-score.

Z-scores are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group. For interpretive purposes, a z-score has a mean of 0 and a standard deviation of 1. This means that an individual who has a z-score of 1.5 is performing one and a half standard deviations above the group to which he/she is compared.

Outcome measures

Measure	Exercise and Cognitive Retraining n=11 Participants Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only n=14 Participants Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility n=14 Participants Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Verbal Memory Score Change baseline	-0.08 score on a scale Standard Deviation 0.20	-0.08 score on a scale Standard Deviation 0.15	0.18 score on a scale Standard Deviation 0.19
Verbal Memory Score Change 3 months	-0.47 score on a scale Standard Deviation 0.21	0.14 score on a scale Standard Deviation 0.18	0.37 score on a scale Standard Deviation 0.20
Verbal Memory Score Change 6 months	-0.20 score on a scale Standard Deviation 0.21	0.07 score on a scale Standard Deviation 0.19	0.25 score on a scale Standard Deviation 0.22

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months

Visual memory will be assessed using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS figure recall requires the participant to remember a recent figure and redraw it from memory. The range of possible scores is 0-20. Scores are averaged, and then converted to z score.

Z-scores are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group. For interpretive purposes, a z-score has a mean of 0 and a standard deviation of 1. This means that an individual who has a z-score of 1.5 is performing one and a half standard deviations above the group to which he/she is compared.

Outcome measures

Measure	Exercise and Cognitive Retraining n=11 Participants Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only n=14 Participants Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility n=14 Participants Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Visual Memory Score Change baseline	-0.09 z scores Standard Deviation 0.23	-0.17 z scores Standard Deviation 0.18	0.29 z scores Standard Deviation 0.22
Visual Memory Score Change 3 months	-0.21 z scores Standard Deviation 0.24	0.08 z scores Standard Deviation 0.21	0.18 z scores Standard Deviation 0.24
Visual Memory Score Change 6 months	-0.90 z scores Standard Deviation 0.25	-0.14 z scores Standard Deviation 0.23	0.32 z scores Standard Deviation 0.25

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months

RBANS coding (0-89) Color Trails 1 (timed test, 1-5 minutes) measures attention. The length of time to complete each part is recorded; lower raw scores reflect better processing speed and attention. Lower raw scores reflect better processing speed and attention. Scores are averaged for a total score, then converted to Z scores.

Z-scores are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group. For interpretive purposes, a z-score has a mean of 0 and a standard deviation of 1. This means that an individual who has a z-score of 1.5 is performing one and a half standard deviations above the group to which he/she is compared.

Outcome measures

Measure	Exercise and Cognitive Retraining n=11 Participants Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only n=14 Participants Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility n=14 Participants Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Change in Processing Speed/Attention Score baseline	-0.09 z scores Standard Deviation 0.11	-0.02 z scores Standard Deviation 0.10	0.12 z scores Standard Deviation 0.11
Change in Processing Speed/Attention Score 3 months	-0.09 z scores Standard Deviation 0.12	0.13 z scores Standard Deviation 0.11	-0.01 z scores Standard Deviation 0.13
Change in Processing Speed/Attention Score 6 months	0.20 z scores Standard Deviation 0.13	-0.02 z scores Standard Deviation 0.12	-0.18 z scores Standard Deviation 0.14

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months

Digit Span Forward (0-16), Digit Span Backwards (0-16), Digit Span Sequencing (0-16) and Letter Number Sequencing (0-48) sections from the Wechsler Adult Intelligence Scale - Fourth Edition are used to assess Working Memory. The range of possible scores for each section are in parentheses. The Digit Span subtest require the repetition of verbally presented series of numbers that increase in length; trials include the repeating of numbers in forward, backward, and numerical order. The Letter-Number sequencing test requires the repeating strings of letters and numbers in numerical and then in alphabetical order. Color Trails Test (CTT) Part 2, participants rapidly connect numbered circles in sequence while alternating between pink and yellow circles. Higher scores reflect better outcome. Scores reflect number correct and are averaged for total correct Working Memory score; are then converted to Z-score.

Outcome measures

Measure	Exercise and Cognitive Retraining n=11 Participants Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only n=14 Participants Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility n=14 Participants Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Change in Working Memory Score baseline	-0.04 z scores Standard Deviation 0.12	0.09 z scores Standard Deviation 0.10	-0.07 z scores Standard Deviation 0.12
Change in Working Memory Score 3 months	-0.03 z scores Standard Deviation 0.13	0.12 z scores Standard Deviation 0.11	-0.16 z scores Standard Deviation 0.13
Change in Working Memory Score 6 months	-0.15 z scores Standard Deviation 0.13	0.10 z scores Standard Deviation 0.12	-0.03 z scores Standard Deviation 0.14

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months

Scores are automatically calculated via the scoring software embedded within the CalCap and are standardized based on age and education level norms. Normative data are stratified by both age (20-34, 35-44, 45+) and education (< 16 years, 16 years, > 16 years). Lower scores reflect slower reaction time and higher scores reflect faster reaction time. Scores are automatically converted to age/education based standard scores and are reported as a T-score.

T-scores (as Z-scores) are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group.

Outcome measures

Measure	Exercise and Cognitive Retraining n=11 Participants Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only n=14 Participants Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility n=14 Participants Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Change in Reaction Time baseline	0.14 t scores Standard Deviation 0.22	0.11 t scores Standard Deviation 0.18	0.29 t scores Standard Deviation 0.22
Change in Reaction Time 3 months	-0.05 t scores Standard Deviation 0.25	0.07 t scores Standard Deviation 0.21	0.18 t scores Standard Deviation 0.24
Change in Reaction Time 6 months	0.02 t scores Standard Deviation 0.24	-0.13 t scores Standard Deviation 0.23	0.30 t scores Standard Deviation 0.26

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months

Functional capacity will be assessed by six-minute walk across all 3 arms of the study.

Outcome measures

Measure	Exercise and Cognitive Retraining n=11 Participants Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only n=14 Participants Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility n=14 Participants Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Functional Capacity baseline	324.1 meters Standard Deviation 19.2	355.1 meters Standard Deviation 15.9	337.6 meters Standard Deviation 18.5
Functional Capacity 3 months	311.1 meters Standard Deviation 20.0	358.8 meters Standard Deviation 16.9	388.4 meters Standard Deviation 20.2
Functional Capacity 6 months	321.2 meters Standard Deviation 20.2	374.9 meters Standard Deviation 18.7	374.9 meters Standard Deviation 20.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

To evaluate change in cardio-respiratory fitness Peak V02 was assessed at baseline and 3 months using a motorized treadmill test across 3 arms of the study

Outcome measures

Measure	Exercise and Cognitive Retraining n=11 Participants Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.	Exercise Only n=14 Participants Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only	Stretching and Flexibility n=14 Participants Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility
Peak V02 3 months	15.9 mL/kg/min Standard Deviation 1.3	16.2 mL/kg/min Standard Deviation 1.0	19.3 mL/kg/min Standard Deviation 1.2
Peak V02 baseline	15.3 mL/kg/min Standard Deviation 1.3	16.0 mL/kg/min Standard Deviation 1.0	19.3 mL/kg/min Standard Deviation 1.1

Adverse Events

Exercise and Cognitive Retraining

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stretching and Flexibility

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gary

Emory University

Phone: 404-727-8360

Email: ragary@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place