Exercise and Cognitive Training in Parkinson's Disease

NCT01156714, Not applicable, Completed, VA Office of Research and Development; results first posted 2019-03-05

Trial 12

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

Field	Value	Source
Title	Exercise and Cognitive Training in Parkinson's Disease	ClinicalTrials.gov
NCT number	NCT01156714	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	59 participants, actual	ClinicalTrials.gov
Lead sponsor	VA Office of Research and Development	ClinicalTrials.gov
Conditions	Parkinson's Disease	ClinicalTrials.gov
Interventions	Treadmill training with aerobic exercise, Memory training with computerized memory program, Combination of treadmill training and computerized memory	ClinicalTrials.gov
First posted	2010-07-05	ClinicalTrials.gov
Last updated	2019-03-05	ClinicalTrials.gov
Results first posted	2019-03-05	ClinicalTrials.gov
Limitations and caveats	High drop-out rate across the board, but particularly in Arm 1.	ClinicalTrials.gov

Registered outcomes 6

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

List	Outcome	Time frame	Description	Source
Primary	Dual Task Function #1	baseline and 3 months	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).	ClinicalTrials.gov
Primary	Dual Task Function #2	baseline and 3 months	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).	ClinicalTrials.gov
Primary	Cognitive Function #1	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.	ClinicalTrials.gov
Primary	Cognitive Function #2	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.	ClinicalTrials.gov
Primary	Timed Instrumental Activities of Daily Living (TIADL) Function #1	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)	ClinicalTrials.gov
Primary	Timed Instrumental Activities of Daily Living (TIADL) Function #2	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.	ClinicalTrials.gov

Outcomes 6

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

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Dual Task Function #1	baseline and 3 months	\\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.	seconds	MEAN	ClinicalTrials.gov
PRIMARY	Dual Task Function #2	baseline and 3 months	\\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.	cm/sec	MEAN	ClinicalTrials.gov
PRIMARY	Cognitive Function #1	baseline and 3 months		correct responses/ minute	MEAN	ClinicalTrials.gov
PRIMARY	Cognitive Function #2	baseline and 3 months		t-score	MEAN	ClinicalTrials.gov
PRIMARY	Timed Instrumental Activities of Daily Living (TIADL) Function #1	baseline and 3 months		z-score	MEAN	ClinicalTrials.gov
PRIMARY	Timed Instrumental Activities of Daily Living (TIADL) Function #2	baseline and 3 months		seconds	MEAN	ClinicalTrials.gov

Results by group 36

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

Outcome	Group	Category	Value	Spread	Units	Source
Dual Task Function #1	Arm 1: Treadmill Training	Cycle Time- baseline	1.15	Standard Error 0.152	seconds	ClinicalTrials.gov
Dual Task Function #1	Arm 2: Memory Training	Cycle Time- baseline	1.12	Standard Error .04	seconds	ClinicalTrials.gov
Dual Task Function #1	Arm 3: Treadmill and Memory Training	Cycle Time- baseline	.987	Standard Error .037	seconds	ClinicalTrials.gov
Dual Task Function #1	Arm 1: Treadmill Training	Cycle Time- 3 months	1.068	Standard Error .0375	seconds	ClinicalTrials.gov
Dual Task Function #1	Arm 2: Memory Training	Cycle Time- 3 months	1.09	Standard Error .052	seconds	ClinicalTrials.gov
Dual Task Function #1	Arm 3: Treadmill and Memory Training	Cycle Time- 3 months	.951	Standard Error .035	seconds	ClinicalTrials.gov
Dual Task Function #2	Arm 1: Treadmill Training	Velocity- baseline	131.194	Standard Error 19.921	cm/sec	ClinicalTrials.gov
Dual Task Function #2	Arm 2: Memory Training	Velocity- baseline	116.944	Standard Error 8.213	cm/sec	ClinicalTrials.gov
Dual Task Function #2	Arm 3: Treadmill and Memory Training	Velocity- baseline	165.165	Standard Error 11.179	cm/sec	ClinicalTrials.gov
Dual Task Function #2	Arm 1: Treadmill Training	Velocity- 3 months	134.7	Standard Error 9.016	cm/sec	ClinicalTrials.gov
Dual Task Function #2	Arm 2: Memory Training	Velocity- 3 months	127.353	Standard Error 10.177	cm/sec	ClinicalTrials.gov
Dual Task Function #2	Arm 3: Treadmill and Memory Training	Velocity- 3 months	174.581	Standard Error 12.985	cm/sec	ClinicalTrials.gov
Cognitive Function #1	Arm 1: Treadmill Training	Two Choice Reaction- baseline	89.3535	Standard Error 6.939	correct responses/ minute	ClinicalTrials.gov
Cognitive Function #1	Arm 2: Memory Training	Two Choice Reaction- baseline	93.413	Standard Error 6.227	correct responses/ minute	ClinicalTrials.gov
Cognitive Function #1	Arm 3: Treadmill and Memory Training	Two Choice Reaction- baseline	101.236	Standard Error 4.588	correct responses/ minute	ClinicalTrials.gov
Cognitive Function #1	Arm 1: Treadmill Training	Two Choice Reaction- 3 months	105.677	Standard Error 7.278	correct responses/ minute	ClinicalTrials.gov
Cognitive Function #1	Arm 2: Memory Training	Two Choice Reaction- 3 months	103.4767	Standard Error 5.497	correct responses/ minute	ClinicalTrials.gov
Cognitive Function #1	Arm 3: Treadmill and Memory Training	Two Choice Reaction- 3 months	119.6465	Standard Error 5.117	correct responses/ minute	ClinicalTrials.gov
Cognitive Function #2	Arm 1: Treadmill Training	Stroop- baseline	48.37	Standard Error 1.278	t-score	ClinicalTrials.gov
Cognitive Function #2	Arm 2: Memory Training	Stroop- baseline	41.74	Standard Error 2.581	t-score	ClinicalTrials.gov

Participant flow 9

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

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Arm 1: Treadmill Training	20	ClinicalTrials.gov
Overall Study	STARTED	Arm 2: Memory Training	19	ClinicalTrials.gov
Overall Study	STARTED	Arm 3: Treadmill and Memory Training	20	ClinicalTrials.gov
Overall Study	COMPLETED	Arm 1: Treadmill Training	11	ClinicalTrials.gov
Overall Study	COMPLETED	Arm 2: Memory Training	15	ClinicalTrials.gov
Overall Study	COMPLETED	Arm 3: Treadmill and Memory Training	17	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Arm 1: Treadmill Training	9	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Arm 2: Memory Training	4	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Arm 3: Treadmill and Memory Training	3	ClinicalTrials.gov

Adverse events 27

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	Events	Source
other	fell at home	Musculoskeletal and connective tissue disorders	Arm 1: Treadmill Training	3	20	5	ClinicalTrials.gov
other	fell at home	Musculoskeletal and connective tissue disorders	Arm 2: Memory Training	1	19	2	ClinicalTrials.gov
other	fell at home	Musculoskeletal and connective tissue disorders	Arm 3: Treadmill and Memory Training	4	20	11	ClinicalTrials.gov
other	Grover's disease	Skin and subcutaneous tissue disorders	Arm 1: Treadmill Training	0	20	0	ClinicalTrials.gov
other	Grover's disease	Skin and subcutaneous tissue disorders	Arm 2: Memory Training	1	19	1	ClinicalTrials.gov
other	Grover's disease	Skin and subcutaneous tissue disorders	Arm 3: Treadmill and Memory Training	0	20	0	ClinicalTrials.gov
other	Fell outside at study site	Musculoskeletal and connective tissue disorders	Arm 1: Treadmill Training	0	20	0	ClinicalTrials.gov
other	Fell outside at study site	Musculoskeletal and connective tissue disorders	Arm 2: Memory Training	1	19	1	ClinicalTrials.gov
other	Fell outside at study site	Musculoskeletal and connective tissue disorders	Arm 3: Treadmill and Memory Training	0	20	0	ClinicalTrials.gov
other	migraine headache	General disorders	Arm 1: Treadmill Training	1	20	2	ClinicalTrials.gov
other	migraine headache	General disorders	Arm 2: Memory Training	0	19	0	ClinicalTrials.gov
other	migraine headache	General disorders	Arm 3: Treadmill and Memory Training	1	20	1	ClinicalTrials.gov
other	mild skin irritation	Skin and subcutaneous tissue disorders	Arm 1: Treadmill Training	0	20	0	ClinicalTrials.gov
other	mild skin irritation	Skin and subcutaneous tissue disorders	Arm 2: Memory Training	0	19	0	ClinicalTrials.gov
other	mild skin irritation	Skin and subcutaneous tissue disorders	Arm 3: Treadmill and Memory Training	1	20	1	ClinicalTrials.gov
other	muscular pain in arm	Musculoskeletal and connective tissue disorders	Arm 1: Treadmill Training	1	20	3	ClinicalTrials.gov
other	muscular pain in arm	Musculoskeletal and connective tissue disorders	Arm 2: Memory Training	0	19	0	ClinicalTrials.gov
other	muscular pain in arm	Musculoskeletal and connective tissue disorders	Arm 3: Treadmill and Memory Training	0	20	0	ClinicalTrials.gov
other	aggravated pre-existing back pain	Musculoskeletal and connective tissue disorders	Arm 1: Treadmill Training	1	20	2	ClinicalTrials.gov
other	aggravated pre-existing back pain	Musculoskeletal and connective tissue disorders	Arm 2: Memory Training	0	19	0	ClinicalTrials.gov

Adverse event totals 9

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Arm 1: Treadmill Training	0	20	ClinicalTrials.gov
Total, all-cause mortality	Arm 2: Memory Training	0	19	ClinicalTrials.gov
Total, all-cause mortality	Arm 3: Treadmill and Memory Training	0	20	ClinicalTrials.gov
Total, other adverse events	Arm 1: Treadmill Training	5	20	ClinicalTrials.gov
Total, other adverse events	Arm 2: Memory Training	3	19	ClinicalTrials.gov
Total, other adverse events	Arm 3: Treadmill and Memory Training	4	20	ClinicalTrials.gov
Total, serious adverse events	Arm 1: Treadmill Training	0	20	ClinicalTrials.gov
Total, serious adverse events	Arm 2: Memory Training	0	19	ClinicalTrials.gov
Total, serious adverse events	Arm 3: Treadmill and Memory Training	1	20	ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

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

Trial comparisons 0

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

Comparison	Source

Tests 2

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
Choice Reaction Time	Primary outcome	ConductCognition
Stroop Color-Word Test	Primary 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)