Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Exercise and Cognitive Training in Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01156714
First received: March 11, 2010
Last updated: July 14, 2016
Last verified: July 2016
  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 VA Office of Research and Development:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 121
Study Start Date: October 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (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. 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 are also comparing each intervention against a control group, to assess the natural history of EF in the investigators' sample and provide insight as to which intervention may delay or even reverse the progression of EF deficits in 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 or compared to "no intervention" (control group).

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
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

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
University of Maryland
Investigators
Principal Investigator: Frederick M Ivey, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01156714     History of Changes
Other Study ID Numbers: E7158-R 
Study First Received: March 11, 2010
Last Updated: July 14, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
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 December 09, 2016