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NCT01156714

Exercise and Cognitive Training in Parkinson's Disease

Completed NA Results posted Last updated 5 March 2019
What this trial tests

NA trial testing Treadmill training with aerobic exercise in Parkinson's Disease in 59 participants. Completed in 30 June 2017.

Timeline
1 October 2010
Primary endpoint
28 February 2017
30 June 2017

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment59
Start date1 October 2010
Primary completion28 February 2017
Estimated completion30 June 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 40 to 90, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dual Task Function #1 Primary · 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).

Cycle Time- baseline
GroupValue95% CI
Arm 1: Treadmill Training1.15± 0.152
Arm 2: Memory Training1.12± .04
Arm 3: Treadmill and Memory Training.987± .037
Cycle Time- 3 months
GroupValue95% CI
Arm 1: Treadmill Training1.068± .0375
Arm 2: Memory Training1.09± .052
Arm 3: Treadmill and Memory Training.951± .035
Dual Task Function #2 Primary · 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).

Velocity- baseline
GroupValue95% CI
Arm 1: Treadmill Training131.194± 19.921
Arm 2: Memory Training116.944± 8.213
Arm 3: Treadmill and Memory Training165.165± 11.179
Velocity- 3 months
GroupValue95% CI
Arm 1: Treadmill Training134.7± 9.016
Arm 2: Memory Training127.353± 10.177
Arm 3: Treadmill and Memory Training174.581± 12.985
Cognitive Function #1 Primary · 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.

Two Choice Reaction- baseline
GroupValue95% CI
Arm 1: Treadmill Training89.3535± 6.939
Arm 2: Memory Training93.413± 6.227
Arm 3: Treadmill and Memory Training101.236± 4.588
Two Choice Reaction- 3 months
GroupValue95% CI
Arm 1: Treadmill Training105.677± 7.278
Arm 2: Memory Training103.4767± 5.497
Arm 3: Treadmill and Memory Training119.6465± 5.117
Cognitive Function #2 Primary · 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.

Stroop- baseline
GroupValue95% CI
Arm 1: Treadmill Training48.37± 1.278
Arm 2: Memory Training41.74± 2.581
Arm 3: Treadmill and Memory Training48.4± 1.54
Stroop- 3 months
GroupValue95% CI
Arm 1: Treadmill Training48.9± 1.642
Arm 2: Memory Training47.8± 2.522
Arm 3: Treadmill and Memory Training47.941± 1.93
Timed Instrumental Activities of Daily Living (TIADL) Function #1 Primary · 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

Timed IADL's Composite- baseline
GroupValue95% CI
Arm 1: Treadmill Training0.131± 0.203
Arm 2: Memory Training.234± .164
Arm 3: Treadmill and Memory Training-.2435± 0.080
Timed IADL's Composite- 3 months
GroupValue95% CI
Arm 1: Treadmill Training0.075± .370
Arm 2: Memory Training.1928± .13866
Arm 3: Treadmill and Memory Training-.34± 0.065
Timed Instrumental Activities of Daily Living (TIADL) Function #2 Primary · 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.

TIADL Shopping- baseline
GroupValue95% CI
Arm 1: Treadmill Training7.339± 3.856
Arm 2: Memory Training6.01± 1.62
Arm 3: Treadmill and Memory Training3.213± 1.05
TIADL Shopping- 3 months
GroupValue95% CI
Arm 1: Treadmill Training3.493± 0.980
Arm 2: Memory Training4.746± 1.346
Arm 3: Treadmill and Memory Training2.39± 0.591

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1: Treadmill Training
Serious: 0/20 (0%)
Deaths: 0/20
Arm 2: Memory Training
Serious: 0/19 (0%)
Deaths: 0/19
Arm 3: Treadmill and Memory Training
Serious: 1/20 (5%)
Deaths: 0/20

Serious adverse events (1 terms)

ReactionSystemArm 1: Treadmill TrainingArm 2: Memory TrainingArm 3: Treadmill and Memor…
Idiopathic orthostatic hypotensionCardiac disorders
Other adverse events (8 terms — click to expand)

ReactionSystemArm 1: Treadmill TrainingArm 2: Memory TrainingArm 3: Treadmill and Memor…
fell at homeMusculoskeletal and connective tissue disorders
dystoniaMusculoskeletal and connective tissue disorders
Grover's diseaseSkin and subcutaneous tissue disorders
Fell outside at study siteMusculoskeletal and connective tissue disorders
migraine headacheGeneral disorders
mild skin irritationSkin and subcutaneous tissue disorders
muscular pain in armMusculoskeletal and connective tissue disorders
aggravated pre-existing back painMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Idiopathic orthostatic hypotension.

Data from ClinicalTrials.gov NCT01156714 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cognitive training interventions for dementia and mild cognitive impairment in Parkinson's disease.
    Orgeta V, McDonald KR, Poliakoff E, Hindle JV, et al · · 2020 · cited 78× · PMID 32101639 · DOI 10.1002/14651858.cd011961.pub2
  2. Effects of motor-cognitive training on dual-task performance in people with Parkinson's disease: a systematic review and meta-analysis.
    Johansson H, Folkerts AK, Hammarström I, Kalbe E, et al · · 2023 · cited 56× · PMID 36820916 · DOI 10.1007/s00415-023-11610-8
  3. Complementary Therapies for Parkinson's Disease: What's Promoted, Rationale, Potential Risks and Benefits.
    Rabin ML, Stevens-Haas C, Havrilla E, Rosenstein A, et al · · 2015 · cited 12× · PMID 30363487 · DOI 10.1002/mdc3.12170

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Other recruiting trials for Parkinson's Disease

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