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Exercise and Cognitive Training in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01156714
First received: March 11, 2010
Last updated: October 29, 2014
Last verified: October 2014

March 11, 2010
October 29, 2014
October 2010
September 2015   (final data collection date for primary outcome measure)
  • Improved dual task ability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Executive Function on a Neuropsychological Test Battery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in instrumental activities of daily living [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improved executive function on a neuropsychological test battery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01156714 on ClinicalTrials.gov Archive Site
Not Provided
  • Improved dual task ability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in instrumental activities of daily living [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Exercise and Cognitive Training in Parkinson's Disease
Effects of Exercise and Cognitive Training on Executive Function in Parkinson's Disease

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).

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. Our 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, our 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 our Baltimore VA study show that we can reproduce similar gains in cardiopulmonary fitness in PD, as reported in the Cochrane review, with a 3-month aerobic exercise program. Our 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, we 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 our sample of veterans and others with PD. We are also comparing each intervention against a control group, to assess the natural history of EF in our sample and provide insight as to which intervention may delay or even reverse the progression of EF deficits in PD.

Our 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 or compared to "no intervention" (control group).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
  • Behavioral: treadmill training
    walk on treadmill for aerobic exercise
  • Behavioral: computerized memory training
    memory testing and training on computer program
  • Arm 1
    Treadmill training with aerobic exercise
    Intervention: Behavioral: treadmill training
  • Arm 2
    Memory training with computerized memory program
    Intervention: Behavioral: computerized memory training
  • Arm 3
    Combination of treadmill training and computerized memory program
    Interventions:
    • Behavioral: treadmill training
    • Behavioral: computerized memory training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
121
June 2016
September 2015   (final data collection date for primary outcome measure)

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
Both
40 Years to 90 Years
No
Contact: Terra Hill (410) 328-5800 thill@som.umaryland.edu
United States
 
NCT01156714
E7158-R
Yes
Department of Veterans Affairs
Department of Veterans Affairs
University of Maryland
Principal Investigator: Fred M Ivey, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Department of Veterans Affairs
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP