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Exercise and Cognitive Training in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01156714
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Behavioral: Treadmill training with aerobic exercise
Behavioral: Memory training with computerized memory program
Behavioral: Combination of treadmill training and computerized memory
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Hide Arm/Group Description

Treadmill training with aerobic exercise

treadmill training: walk on treadmill for aerobic exercise

Memory training with computerized memory program

computerized memory training: memory testing and training on computer program

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

Period Title: Overall Study
Started 20 19 20
Completed 11 15 17
Not Completed 9 4 3
Reason Not Completed
Withdrawal by Subject             9             4             3
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training Total
Hide Arm/Group Description

Treadmill training with aerobic exercise

treadmill training: walk on treadmill for aerobic exercise

Memory training with computerized memory program

computerized memory training: memory testing and training on computer program

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 of all reporting groups
Overall Number of Baseline Participants 20 19 20 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 20 participants 59 participants
63.2  (11.28) 73.68  (8.38) 64.55  (7.07) 67.00  (9.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 20 participants 59 participants
Female
6
  30.0%
5
  26.3%
4
  20.0%
15
  25.4%
Male
14
  70.0%
14
  73.7%
16
  80.0%
44
  74.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 20 participants 59 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  10.0%
0
   0.0%
1
   5.0%
3
   5.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  15.0%
5
  26.3%
1
   5.0%
9
  15.3%
White
15
  75.0%
14
  73.7%
18
  90.0%
47
  79.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hoehn & Yahr Parkinson's Disease Severity Rating   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 20 participants 59 participants
2.34  (.41) 2.42  (.42) 2.35  (.54) 2.42  (.55)
[1]
Measure Description: The Hoehn & Yahr scale measures general staging of Parkinson's disease progression. Classification ranges from 1 to 5, with higher scores indicating greater disability. The range of scale scores acceptable for this study was 1 to 3 (1 = Unilateral involvement only, usually with minimal or no functional impairment, 2 = Bilateral or midline involvement, without impairment of balance, 3= First sign of impaired righting reflexes; patients are physically capable of leading independent lives, and their disability is mild to moderate). This assessment was performed by a movement disorders specialist.
1.Primary Outcome
Title Dual Task Function #1
Hide Description

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).

Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
**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.
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Hide Arm/Group Description:

Treadmill training with aerobic exercise

treadmill training: walk on treadmill for aerobic exercise

Memory training with computerized memory program

computerized memory training: memory testing and training on computer program

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 Number of Participants Analyzed 8 13 15
Mean (Standard Error)
Unit of Measure: seconds
Cycle Time- baseline 1.15  (0.152) 1.12  (.04) .987  (.037)
Cycle Time- 3 months 1.068  (.0375) 1.09  (.052) .951  (.035)
2.Primary Outcome
Title Dual Task Function #2
Hide Description

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).

Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
**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.
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Hide Arm/Group Description:

Treadmill training with aerobic exercise

Treadmill training with aerobic exercise: walk on treadmill for aerobic exercise

Memory training with computerized memory program

Memory training with computerized memory program: memory testing and training on computer program

Combination of treadmill training and computerized memory program

Combination of treadmill training and computerized memory: both exercise and cognitive computer training

Overall Number of Participants Analyzed 8 13 15
Mean (Standard Error)
Unit of Measure: cm/sec
Velocity- baseline 131.194  (19.921) 116.944  (8.213) 165.165  (11.179)
Velocity- 3 months 134.7  (9.016) 127.353  (10.177) 174.581  (12.985)
3.Primary Outcome
Title Cognitive Function #1
Hide Description 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.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Hide Arm/Group Description:

Treadmill training with aerobic exercise

treadmill training: walk on treadmill for aerobic exercise

Memory training with computerized memory program

computerized memory training: memory testing and training on computer program

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 Number of Participants Analyzed 11 15 17
Mean (Standard Error)
Unit of Measure: correct responses/ minute
Two Choice Reaction- baseline 89.3535  (6.939) 93.413  (6.227) 101.236  (4.588)
Two Choice Reaction- 3 months 105.677  (7.278) 103.4767  (5.497) 119.6465  (5.117)
4.Primary Outcome
Title Cognitive Function #2
Hide Description 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.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Hide Arm/Group Description:

Treadmill training with aerobic exercise

Treadmill training with aerobic exercise: walk on treadmill for aerobic exercise

Memory training with computerized memory program

Memory training with computerized memory program: memory testing and training on computer program

Combination of treadmill training and computerized memory program

Combination of treadmill training and computerized memory: both exercise and cognitive computer training

Overall Number of Participants Analyzed 11 15 17
Mean (Standard Error)
Unit of Measure: t-score
Stroop- baseline 48.37  (1.278) 41.74  (2.581) 48.4  (1.54)
Stroop- 3 months 48.9  (1.642) 47.8  (2.522) 47.941  (1.93)
5.Primary Outcome
Title Timed Instrumental Activities of Daily Living (TIADL) Function #1
Hide Description 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)
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Hide Arm/Group Description:

Treadmill training with aerobic exercise

treadmill training: walk on treadmill for aerobic exercise

Memory training with computerized memory program

computerized memory training: memory testing and training on computer program

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 Number of Participants Analyzed 11 15 17
Mean (Standard Error)
Unit of Measure: z-score
Timed IADL's Composite- baseline 0.131  (0.203) .234  (.164) -.2435  (0.080)
Timed IADL's Composite- 3 months 0.075  (.370) .1928  (.13866) -.34  (0.065)
6.Primary Outcome
Title Timed Instrumental Activities of Daily Living (TIADL) Function #2
Hide Description 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.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Hide Arm/Group Description:

Treadmill training with aerobic exercise

Treadmill training with aerobic exercise: walk on treadmill for aerobic exercise

Memory training with computerized memory program

Memory training with computerized memory program: memory testing and training on computer program

Combination of treadmill training and computerized memory program

Combination of treadmill training and computerized memory: both exercise and cognitive computer training

Overall Number of Participants Analyzed 11 15 17
Mean (Standard Error)
Unit of Measure: seconds
TIADL Shopping- baseline 7.339  (3.856) 6.01  (1.62) 3.213  (1.05)
TIADL Shopping- 3 months 3.493  (0.980) 4.746  (1.346) 2.39  (0.591)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Hide Arm/Group Description

Treadmill training with aerobic exercise

treadmill training: walk on treadmill for aerobic exercise

Memory training with computerized memory program

computerized memory training: memory testing and training on computer program

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

All-Cause Mortality
Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/19 (0.00%)      0/20 (0.00%)    
Hide Serious Adverse Events
Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/19 (0.00%)      1/20 (5.00%)    
Cardiac disorders       
Idiopathic orthostatic hypotension  [1]  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
Participant arrived for study visit and per protocol blood pressure readings were taken which endorsed orthostasis. Participant was taken to ER accompanied by study staff and recovered. Orthostasis is a symptom of PD.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Treadmill Training Arm 2: Memory Training Arm 3: Treadmill and Memory Training
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      3/19 (15.79%)      4/20 (20.00%)    
General disorders       
migraine headache  [1]  1/20 (5.00%)  2 0/19 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders       
fell at home  [2]  3/20 (15.00%)  5 1/19 (5.26%)  2 4/20 (20.00%)  11
Fell outside at study site  [3]  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
muscular pain in arm  [4]  1/20 (5.00%)  3 0/19 (0.00%)  0 0/20 (0.00%)  0
aggravated pre-existing back pain  [5]  1/20 (5.00%)  2 0/19 (0.00%)  0 1/20 (5.00%)  1
dystonia  [6]  2/20 (10.00%)  2 0/19 (0.00%)  0 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Grover's disease  [7]  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
mild skin irritation  [8]  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
participant experienced migraine headache at home.
[2]
fall
[3]
Participant fell outside study site on curb following intervention visit.
[4]
participant reported arm pain while doing treadmill intervention. Physician assessed participant and suggested he might be holding too tightly to the railing. Participant reported this event on 3 different occasions.
[5]
During treadmill intervention participants reported aggravated back pain.
[6]
increase in PD symptom
[7]
Pt diagnosed during study participation, sought treatment, and was provided prescription topical treatment.
[8]
skin irritation from harness used in treadmill training intervention. Participant sought treatment, was given topical ointment, rash cleared.
High drop-out rate across the board, but particularly in Arm 1.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fred Ivey
Organization: VAORD
Phone: 410-605-7000 ext 6582
EMail: Frederick.Ivey@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01156714    
Other Study ID Numbers: E7158-R
First Submitted: March 11, 2010
First Posted: July 5, 2010
Results First Submitted: January 19, 2018
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019