Exercise and Cognitive Training in Parkinson's Disease

NCT01156714 | Completed Results DMC

• 1 other identifier: E7158-R
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Treadmill Training; Exercise; Cognitive Training; Executive Function; Dual Task

Outcome Measures

Primary Outcomes (6)

• 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).

  baseline and 3 months

• 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).

  baseline and 3 months

• 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.

  baseline and 3 months

• 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.

  baseline and 3 months

• 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)

  baseline and 3 months

• 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.

  baseline and 3 months

Study Arms (3)

Arm 1: Treadmill Training

OTHER

Treadmill training with aerobic exercise

Behavioral: Treadmill training with aerobic exercise

Arm 2: Memory Training

OTHER

Memory training with computerized memory program

Behavioral: Memory training with computerized memory program

Arm 3: Treadmill and Memory Training

OTHER

Combination of treadmill training and computerized memory program

Behavioral: Combination of treadmill training and computerized memory

Interventions

Treadmill training with aerobic exercise BEHAVIORAL

walk on treadmill for aerobic exercise

Arm 1: Treadmill Training

Memory training with computerized memory program BEHAVIORAL

memory testing and training on computer program

Arm 2: Memory Training

Combination of treadmill training and computerized memory BEHAVIORAL

both exercise and cognitive computer training

Arm 3: Treadmill and Memory Training

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Maryland: collaborator

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise; Cognitive Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

High drop-out rate across the board, but particularly in Arm 1.

Results Point of Contact

• Title: Fred Ivey
• Organization: VAORD

Frederick.Ivey@va.gov

410-605-7000

Study Officials

• Frederick M Ivey, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: July 5, 2010
• Study Start: October 1, 2010
• Primary Completion: February 28, 2017
• Study Completion: June 30, 2017
• Last Updated: March 5, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)