Exercise and Cognitive Training in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 14, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Parkinson's Disease
Behavioral: treadmill training
Behavioral: computerized memory training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Exercise and Cognitive Training on Executive Function in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Executive Function on a Neuropsychological Test Battery [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 121
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Treadmill training with aerobic exercise
Behavioral: treadmill training
walk on treadmill for aerobic exercise
Arm 2
Memory training with computerized memory program
Behavioral: computerized memory training
memory testing and training on computer program
Arm 3
Combination of treadmill training and computerized memory program
Behavioral: treadmill training
walk on treadmill for aerobic exercise
Behavioral: computerized memory training
memory testing and training on computer program

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. 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).

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156714

Contacts
Contact: Terra Hill (410) 328-5800 thill@som.umaryland.edu
Contact: Ashley Thomas, BS (410) 637-3218

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Terra Hill    410-328-5800    thill@som.umaryland.edu   
Principal Investigator: Fred Ivey, PhD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Fred Ivey, PhD VA Maryland Health Care System, Baltimore
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01156714     History of Changes
Other Study ID Numbers: E7158-R
Study First Received: March 11, 2010
Last Updated: May 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Parkinson's Disease
Treadmill Training
Exercise
Cognitive Training
Executive Function
Dual Task

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 18, 2014