Trial Outcomes & Findings for Exercise and Cognitive Training in Parkinson's Disease (NCT NCT01156714)

NCT ID: NCT01156714

Last Updated: 2019-03-05

Results Overview

Dual task tested functional and cognitive performance while walking and talking simultaneously. Walking spatial and temporal parameters were measured using the Gaitrite 24 foot gaitmat with existing hardware and software for analysis. Cycle time refers to the amount of time taken for a participant to complete a single stride. Lower scores indicate better outcomes. The range of scores for Cycle Time is: Pre (0.73-2.47), Post (0.72-1.45).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: baseline and 3 months
• Results posted on: 2019-03-05

Participant Flow

Participant milestones

Measure	Arm 1: Treadmill Training Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Overall Study STARTED	20	19	20
Overall Study COMPLETED	11	15	17
Overall Study NOT COMPLETED	9	4	3

Reasons for withdrawal

Measure	Arm 1: Treadmill Training Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Overall Study Withdrawal by Subject	9	4	3

Baseline Characteristics

Exercise and Cognitive Training in Parkinson's Disease

Baseline characteristics by cohort

Measure	Arm 1: Treadmill Training n=20 Participants Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=19 Participants Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=20 Participants Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program	Total n=59 Participants Total of all reporting groups
Age, Continuous	63.2 Years STANDARD_DEVIATION 11.28 • n=5 Participants	73.68 Years STANDARD_DEVIATION 8.38 • n=7 Participants	64.55 Years STANDARD_DEVIATION 7.07 • n=5 Participants	67.00 Years STANDARD_DEVIATION 9.36 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants	44 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	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 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	3 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 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
Hoehn & Yahr Parkinson's Disease Severity Rating	2.34 units on a scale STANDARD_DEVIATION .41 • n=5 Participants	2.42 units on a scale STANDARD_DEVIATION .42 • n=7 Participants	2.35 units on a scale STANDARD_DEVIATION .54 • n=5 Participants	2.42 units on a scale STANDARD_DEVIATION .55 • n=4 Participants

PRIMARY outcome

Timeframe: baseline and 3 months

Population: \*\*Please note that initiation of dual-task testing was delayed by the original PI at the start of this study, such that some early participants were missed. This caused the dual-task outcome category to have lower numbers analyzed than other outcomes.

Dual task tested functional and cognitive performance while walking and talking simultaneously. Walking spatial and temporal parameters were measured using the Gaitrite 24 foot gaitmat with existing hardware and software for analysis.

Cycle time refers to the amount of time taken for a participant to complete a single stride. Lower scores indicate better outcomes. The range of scores for Cycle Time is: Pre (0.73-2.47), Post (0.72-1.45).

Outcome measures

Measure	Arm 1: Treadmill Training n=8 Participants Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=13 Participants Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=15 Participants Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Dual Task Function #1 Cycle Time- baseline	1.15 seconds Standard Error 0.152	1.12 seconds Standard Error .04	.987 seconds Standard Error .037
Dual Task Function #1 Cycle Time- 3 months	1.068 seconds Standard Error .0375	1.09 seconds Standard Error .052	.951 seconds Standard Error .035

PRIMARY outcome

Timeframe: baseline and 3 months

Population: \*\*Please note that initiation of dual-task testing was delayed by the original PI at the start of this study, such that some early participants were missed. This caused the dual-task outcome category to have lower numbers analyzed than other outcomes.

Dual task tested functional and cognitive performance while walking and talking simultaneously. Walking spatial and temporal parameters were measured using the Gaitrite 24 foot gaitmat with existing hardware and software for analysis.

Velocity was calculated by dividing the distance by the time it takes to travel that same distance, with consideration for direction. Higher values represent better outcomes. The range of scores for this study was: Pre (36.4 - 269.4), Post (76.3 - 267.6).

Outcome measures

Measure	Arm 1: Treadmill Training n=8 Participants Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=13 Participants Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=15 Participants Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Dual Task Function #2 Velocity- baseline	131.194 cm/sec Standard Error 19.921	116.944 cm/sec Standard Error 8.213	165.165 cm/sec Standard Error 11.179
Dual Task Function #2 Velocity- 3 months	134.7 cm/sec Standard Error 9.016	127.353 cm/sec Standard Error 10.177	174.581 cm/sec Standard Error 12.985

PRIMARY outcome

Timeframe: baseline and 3 months

2-Choice Reaction Time measures patients' ability to shift mental set. One of two stimuli are presented on the screen ("+ "or "*"). Subjects press a specified response button on the keyboard corresponding to the presented stimulus. Units are "Throughput", which reflects efficiency of performance by being based on both accuracy and speed. Throughput represents correct responses/ minute.

Outcome measures

Measure	Arm 1: Treadmill Training n=11 Participants Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=15 Participants Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=17 Participants Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Cognitive Function #1 Two Choice Reaction- baseline	89.3535 correct responses/ minute Standard Error 6.939	93.413 correct responses/ minute Standard Error 6.227	101.236 correct responses/ minute Standard Error 4.588
Cognitive Function #1 Two Choice Reaction- 3 months	105.677 correct responses/ minute Standard Error 7.278	103.4767 correct responses/ minute Standard Error 5.497	119.6465 correct responses/ minute Standard Error 5.117

PRIMARY outcome

Timeframe: baseline and 3 months

The Stroop is a measure of selective attention and cognitive flexibility in which the subject must inhibit a preponderant response. Subjects are asked to complete three parts under timed conditions: (1) reading words describing colors written in black-and-white, (2) naming those colors when printed as X's, (3) naming the ink color when words describing the colors are mismatched with the colors (suppressing verbal content). Stroop interference scores from condition 3 are t-scores and higher scores equate with better outcomes.

Outcome measures

Measure	Arm 1: Treadmill Training n=11 Participants Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=15 Participants Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=17 Participants Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Cognitive Function #2 Stroop- baseline	48.37 t-score Standard Error 1.278	41.74 t-score Standard Error 2.581	48.4 t-score Standard Error 1.54
Cognitive Function #2 Stroop- 3 months	48.9 t-score Standard Error 1.642	47.8 t-score Standard Error 2.522	47.941 t-score Standard Error 1.93

PRIMARY outcome

Timeframe: baseline and 3 months

The Timed IADL involves the timing of performance of 5 tasks that mimic everyday instrumental activities of daily living: 1) finding a telephone number in the telephone directory, 2) counting out correct change from a group of coins, 3) finding then reading the ingredients on a food can label, 4) finding two food items in an array of food items (shopping), 5) finding then reading the directions on a medicine container. For each task there is a 2 minute time limit, with the exception of the telephone number task which has a limit of 3 mins. If the task is not completed within the time limit it is terminated. Error codes are assigned for each task. For the tasks completed with minor errors, a time penalty of 1 SD of those who completed the task is added to the completion time. Higher single item scores mean worse performance.The times for each of the tasks are transformed into Z scores which are then summed to form a composite score. Range for shopping item (0.61- 69.9 sec)

Outcome measures

Measure	Arm 1: Treadmill Training n=11 Participants Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=15 Participants Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=17 Participants Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Timed Instrumental Activities of Daily Living (TIADL) Function #1 Timed IADL's Composite- baseline	0.131 z-score Standard Error 0.203	.234 z-score Standard Error .164	-.2435 z-score Standard Error 0.080
Timed Instrumental Activities of Daily Living (TIADL) Function #1 Timed IADL's Composite- 3 months	0.075 z-score Standard Error .370	.1928 z-score Standard Error .13866	-.34 z-score Standard Error 0.065

PRIMARY outcome

Timeframe: baseline and 3 months

The Timed IADL for Shopping involved finding two food items in an array of food items. The task was timed in seconds and if completed with minor errors, a time penalty was added to the completion time. Higher scores/times meant worse performance. The range for shopping task completion was 0.61 to 69.9 seconds.

Outcome measures

Measure	Arm 1: Treadmill Training n=11 Participants Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=15 Participants Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=17 Participants Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Timed Instrumental Activities of Daily Living (TIADL) Function #2 TIADL Shopping- baseline	7.339 seconds Standard Error 3.856	6.01 seconds Standard Error 1.62	3.213 seconds Standard Error 1.05
Timed Instrumental Activities of Daily Living (TIADL) Function #2 TIADL Shopping- 3 months	3.493 seconds Standard Error 0.980	4.746 seconds Standard Error 1.346	2.39 seconds Standard Error 0.591

Adverse Events

Arm 1: Treadmill Training

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 2: Memory Training

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 3: Treadmill and Memory Training

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1: Treadmill Training n=20 participants at risk Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=19 participants at risk Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=20 participants at risk Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Cardiac disorders Idiopathic orthostatic hypotension	0.00% 0/20 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/19 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	5.0% 1/20 • Number of events 1 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.

Other adverse events

Measure	Arm 1: Treadmill Training n=20 participants at risk Treadmill training with aerobic exercise treadmill training: walk on treadmill for aerobic exercise	Arm 2: Memory Training n=19 participants at risk Memory training with computerized memory program computerized memory training: memory testing and training on computer program	Arm 3: Treadmill and Memory Training n=20 participants at risk Combination of treadmill training and computerized memory program treadmill training: walk on treadmill for aerobic exercise computerized memory training: memory testing and training on computer program
Musculoskeletal and connective tissue disorders fell at home	15.0% 3/20 • Number of events 5 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	5.3% 1/19 • Number of events 2 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	20.0% 4/20 • Number of events 11 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.
Skin and subcutaneous tissue disorders Grover's disease	0.00% 0/20 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	5.3% 1/19 • Number of events 1 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/20 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.
Musculoskeletal and connective tissue disorders Fell outside at study site	0.00% 0/20 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	5.3% 1/19 • Number of events 1 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/20 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.
General disorders migraine headache	5.0% 1/20 • Number of events 2 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/19 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	5.0% 1/20 • Number of events 1 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.
Skin and subcutaneous tissue disorders mild skin irritation	0.00% 0/20 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/19 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	5.0% 1/20 • Number of events 1 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.
Musculoskeletal and connective tissue disorders muscular pain in arm	5.0% 1/20 • Number of events 3 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/19 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/20 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.
Musculoskeletal and connective tissue disorders aggravated pre-existing back pain	5.0% 1/20 • Number of events 2 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/19 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	5.0% 1/20 • Number of events 1 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.
Musculoskeletal and connective tissue disorders dystonia	10.0% 2/20 • Number of events 2 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/19 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.	0.00% 0/20 • Adverse events were collected during a 5 month subject participation period which included 1 month of baseline testing, 3 months of intervention, and 1 month of post-testing.

Additional Information

Fred Ivey

VAORD

Phone: 410-605-7000

Email: Frederick.Ivey@va.gov

Results disclosure agreements

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