Parkinson's DiseaseNCT01156714
Exercise and Cognitive Training in Parkinson's Disease
A study testing Treadmill training with aerobic exercise, Memory training with computerized memory program and Combination of treadmill training and computerized memory in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Treadmill training with aerobic exercise, Memory training with computerized memory program and Combination of treadmill training and computerized memory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2010to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease stage 1-3 Hoehn and Yahr
- Balance problems
Who cannot join
- unstable medical illness
- unstable psychiatric illness
- exercising too much on own
- doing computerized memory training on own
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: 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).
Read the 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' 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.
- Conditions
- Parkinson's Disease
- Being tested
- Treadmill training with aerobic exercise, Memory training with computerized memory program, Combination of treadmill training and computerized memory
- Keywords
- Parkinson's Disease, Treadmill Training, Exercise, Cognitive Training, Executive Function, Dual Task
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill training with aerobic exerciseBehavioural
walk on treadmill for aerobic exercise
Memory training with computerized memory programBehavioural
memory testing and training on computer program
Combination of treadmill training and computerized memoryBehavioural
both exercise and cognitive computer training
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Treadmill Training | Other | Treadmill training with aerobic exercise Receives: Behavioral: Treadmill training with aerobic exercise |
| Arm 2: Memory Training | Other | Memory training with computerized memory program Receives: Behavioral: Memory training with computerized memory program |
| Arm 3: Treadmill and Memory Training | Other | Combination of treadmill training and computerized memory program Receives: Behavioral: Combination of treadmill training and computerized memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study start1 Oct 2010
- Primary completion28 Feb 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
- Investigators
- Frederick M Ivey, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156714
- Sponsor's protocol ID
- E7158-R
- Status last verified
- Feb 2019
- First submitted
- 11 Mar 2010
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Cognitive Training on Executive Function in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01156714
- Acronym / sponsor ID
- E7158-R
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Treadmill Training, Exercise, Cognitive Training, Executive Function, Dual Task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Maryland
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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' 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Treadmill Training | Other | Behavioral: Treadmill training with aerobic exerciseTreadmill training with aerobic exercise |
| Arm 2: Memory Training | Other | Behavioral: Memory training with computerized memory programMemory training with computerized memory program |
| Arm 3: Treadmill and Memory Training | Other | Behavioral: Combination of treadmill training and computerized memoryCombination of treadmill training and computerized memory program |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson's disease stage 1-3 Hoehn and Yahr
- Balance problems
Key exclusion criteria (4 listed)
- unstable medical illness
- unstable psychiatric illness
- exercising too much on own
- doing computerized memory training on own
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill training with aerobic exercisewalk on treadmill for aerobic exercise | Behavioural | Arm 1: Treadmill Training |
| Memory training with computerized memory programmemory testing and training on computer program | Behavioural | Arm 2: Memory Training |
| Combination of treadmill training and computerized memoryboth exercise and cognitive computer training | Behavioural | Arm 3: Treadmill and Memory Training |
Primary outcome
Dual Task Function #1
Time frame: 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).
Dual Task Function #2
Time frame: 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).
Cognitive Function #1
Time frame: 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.
Cognitive Function #2
Time frame: 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.
Timed Instrumental Activities of Daily Living (TIADL) Function #1
Time frame: 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 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)
Timed Instrumental Activities of Daily Living (TIADL) Function #2
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick M Ivey, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training with aerobic exercise, Memory training with computerized memory program and Combination of treadmill training and computerized memory in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Task Function #1 (time frame: baseline and 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.