search
Back to results

Exercise and Cognitive Training in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill training with aerobic exercise
Memory training with computerized memory program
Combination of treadmill training and computerized memory
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Treadmill Training, Exercise, Cognitive Training, Executive Function, Dual Task

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parkinson's disease stage 1-3 Hoehn and Yahr
  • Balance problems

Exclusion Criteria:

  • unstable medical illness
  • unstable psychiatric illness
  • exercising too much on own
  • doing computerized memory training on own

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Arm 1: Treadmill Training

Arm 2: Memory Training

Arm 3: Treadmill and Memory Training

Arm Description

Treadmill training with aerobic exercise

Memory training with computerized memory program

Combination of treadmill training and computerized memory program

Outcomes

Primary Outcome Measures

Dual Task Function #1
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).
Dual Task Function #2
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).
Cognitive Function #1
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.
Cognitive Function #2
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.
Timed Instrumental Activities of Daily Living (TIADL) Function #1
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)
Timed Instrumental Activities of Daily Living (TIADL) Function #2
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.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2010
Last Updated
February 28, 2019
Sponsor
VA Office of Research and Development
Collaborators
University of Maryland
search

1. Study Identification

Unique Protocol Identification Number
NCT01156714
Brief Title
Exercise and Cognitive Training in Parkinson's Disease
Official Title
Effects of Exercise and Cognitive Training on Executive Function in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2010 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Maryland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study compares the effects treadmill exercise, computerized cognitive training, or the combination of the two on executive function, dual-task performance, and performance on several Instrumental Activities of Daily Living (IADLs).
Detailed Description
Parkinson's Disease (PD) is recognized as both a motor and nonmotor disorder. Gait and mobility impairments are often associated with a decline of cognitive function, particularly executive function (EF), among other non-motor signs. EF is a broad category of cognitive functions that is generally defined as those processes necessary for purposeful, goal-directed behavior and supervision of ongoing cognitive processes. Deficits in EF are frequently seen early in PD4 and progress with time, often resulting in disruption of daily activities. People with PD are often impaired in real life situations in which more than one activity needs to be performed at a time. Dual tasking (DT) is defined as the performance of two different tasks simultaneously, commonly a gait plus a cognitive task. This study investigates the interaction of motor (gait) and non-motor (cognitive) impairments in PD. Studies of DT suggest that reciprocal interactions exist between gait and mental functions that are fundamental to the performance of daily activities. Therefore, the model of DT encompasses 2 major areas of PD-related impairment in a single outcome measure that is highly correlated with daily function. Performance on DT generally results in degradation of gait and/or cognitive performance. The investigators' pilot study in 125 people with PD has shown significant DT interference producing a 22% decline in gait velocity. This demonstrates deterioration of gait performance when subjects allocate attention to the cognitive task. Importantly, deficits on DT correlates with in problems in daily function, especially instrumental activities of daily living (IADLs), and is associated with increased risk of falling and driving impairment. Similarly, the investigators' pilot data in patients with moderate stage PD shows that deficits in DT performance are associated with poor IADL performance. Although cognitive deficits contribute to disability in PD, there are no treatments that effectively address this problem, and no studies have systematically investigated the potential benefits of rehabilitation strategies to improve cognitive function and related disability in this population. Emerging evidence suggests the potential of physical exercise and cognitive training to improve cognitive function in healthy elderly and individuals with chronic neurologic conditions. A Cochrane meta-analysis on the cognitive effects of aerobic exercise in older adults has shown that improvement of peak VO2 levels by a mean of 14% (range 5-20%) was associated with improvement in cognitive function, particularly EF domains including speed of motor processing and attention. These are the same EF domains in which deficits commonly occur in PD. Pilot data from the investigators' Baltimore VA study show that the investigators can reproduce similar gains in cardiopulmonary fitness in PD, as reported in the Cochrane review, with a 3-month aerobic exercise program. The investigators' group has also reported improvement of selected EF domains (attention and speed of processing) following 2 months of aerobic exercise in stroke patients12. Cognitive training is another potential rehabilitation modality to improve cognitive function. Recent studies in numerous neurological conditions and healthy older adults show that cognitive training improves cognition, with EF most likely to respond among all cognitive domains. In this project, the investigators are comparing the effectiveness of a treadmill aerobic exercise program (TAEX) versus a cognitive training program (TCOG) versus the combination of TAEX + TCOG for improving EF, DT performance and IADLs in the investigators' sample of Veterans and others with PD. The investigators' fundamental hypothesis is that 3 months of combined TAEX+TCOG will be most effective in improving EF, DT performance, and IADLs, compared to either regimen alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Treadmill Training, Exercise, Cognitive Training, Executive Function, Dual Task

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Treadmill Training
Arm Type
Other
Arm Description
Treadmill training with aerobic exercise
Arm Title
Arm 2: Memory Training
Arm Type
Other
Arm Description
Memory training with computerized memory program
Arm Title
Arm 3: Treadmill and Memory Training
Arm Type
Other
Arm Description
Combination of treadmill training and computerized memory program
Intervention Type
Behavioral
Intervention Name(s)
Treadmill training with aerobic exercise
Intervention Description
walk on treadmill for aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Memory training with computerized memory program
Intervention Description
memory testing and training on computer program
Intervention Type
Behavioral
Intervention Name(s)
Combination of treadmill training and computerized memory
Intervention Description
both exercise and cognitive computer training
Primary Outcome Measure Information:
Title
Dual Task Function #1
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
Title
Dual Task Function #2
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
Title
Cognitive Function #1
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
Title
Cognitive Function #2
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
Title
Timed Instrumental Activities of Daily Living (TIADL) Function #1
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
Title
Timed Instrumental Activities of Daily Living (TIADL) Function #2
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parkinson's disease stage 1-3 Hoehn and Yahr Balance problems Exclusion Criteria: unstable medical illness unstable psychiatric illness exercising too much on own doing computerized memory training on own
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick M Ivey, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise and Cognitive Training in Parkinson's Disease

We'll reach out to this number within 24 hrs