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The Effect of Exercise on Individuals With Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive resistance training
Modified Fitness Counts
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, exercise

Eligibility Criteria

50 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a diagnosis of PD
  • Up to the age of 67
  • on at least 1 DA drug, may be on several PD medications
  • able to walk for six minutes (may take rest breaks)
  • able to come off their PD medication for testing (12 hour overnight withdrawal of antiparkinsonian medications)
  • able to stay on stable PD medications for at least 6 months
  • live within a 30 mile radius of Chicago
  • Hoehn and Yahr Score: II - III while in the "Off" PD medication state

Exclusion Criteria:

  • history of any other neurological disorder as determined by medical history and neurological exam
  • history of a known injury, disease, or other disorder that might interfere with motor function in the proposed experiments
  • a score less than 23 on the Mini-Mental State Examination
  • currently involved in an active, ongoing formal exercise program deep brain stimulation surgery
  • known cardiac problem or significant hypertension
  • depression that may interfere with regular exercise
  • hallucinations or being treated for hallucinations

Sites / Locations

  • Physical Therapy Department at the University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Progressive resistance training

Modified Fitness Counts

Arm Description

Subjects will perform between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.

Subjects will perform between 60 and 90 minutes of modified Fitness Counts two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.

Outcomes

Primary Outcome Measures

Off Medication UPDRS Part III, Motor Subscale Score
UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.

Secondary Outcome Measures

On Medication UPDRS-III
UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for the UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.
L-dopa equivalent-mg/Day
This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.
Elbow Flexion Strength
This is the MVC for elbow flexion
Ankle Plantar Flexion Strength
This is a measure of the MVC for ankle plantar flexion strength
Elbow Extension Strength
This is a measure of the MVC for elbow extension
Ankle Dorsiflexion Strength
This is a measure of the MVC for ankle dorsiflexion
Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions
This is a measure of the percentage of the EMG signal that is contained in different frequency bins during a MVC (elbow flexion/extension; ankle DF/PF), a 50% of MVC elbow fleixon contraction, and a 5 NM elbow flexion contraction.
The Integral of the First Agonist Burst
The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity
Magnitude of the First 30 ms of the Agonist Burst
The integral of the first 30 msec of the agonist EMG.
Magnitude of the Antagonist Burst
the area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.
Magnitude of the Agonist Burst
Magnitude of the agonist burst reflects the amount of agonist activation during movement.
Duration of First Agonist Burst
Time in (ms) for the duration of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity
Number of Agonist Bursts
This is the number of agonist bursts prior to peak velocity.
Co-contraction During Limb Acceleration
the amount of agonist and antagonist activity present during limb acceleration.
Qant
The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement
Time to Peak Velocity
Time of the onset of the movement to peak velocity.
Peak Movement Velocity
This is how fast an individual can perform a 72 degree elbow flexion movement
Relaxation Time
Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC
Rise Time
This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.
Spatiotemporal Gait Analysis
Spatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.
Distance Walked in 6 Minutes
This is how far an individual can walk in 6 minutes
Modified Physical Performance Test
This is an overall measure of physical fuction
Time on the Timed up and go Test
This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.
Berg Balance Scale Score
This is a overall measure of balance
Functional Reach
The distance one can reach forward without taking a step.
Cognitive Function - Stroop Test
This is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.
Cognitive Function - Brief Test of Attention
This is a cognitive test of an individuals ability to remember number. It is a test of working memory.
Cognitive Function - Digit Span Forward/Backward
This tests a persons ability to remember that were read to them both forward and then backwards.
Parkinson 's Disease Quality of Life
PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.
Beck's Depression Inventory
This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.
50 ft Walk Time
Time it takes to walk 50 feet
50 Foot Walk Speed
The speed that aerson walks over 50 feet
5 Time Sit to Stand
The time it takes to stand up and sit down five times

Full Information

First Posted
December 26, 2007
Last Updated
February 16, 2015
Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00591344
Brief Title
The Effect of Exercise on Individuals With Parkinson's Disease
Official Title
The Effect of Exercise on Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this trial is to compare the effect of two different exercise programs on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease to determine which program is most beneficial.
Detailed Description
Parkinson's disease (PD) negatively affects the quality of life for a million individuals in the United States. While medication and surgery are the most effective treatments for PD, physicians and people with PD often delay using these treatments because of their considerable adverse side effects. Until a cure for PD is discovered, there is a compelling need to develop interventions that provide relief of symptoms without causing negative side effects. Recent research suggests that exercise may provide symptom relief in some characteristics of PD. While various exercise interventions appear to effectively improve motor, functional, and quality-of-life issues, the research is mixed regarding the nature, extent and duration of these improvements. Understanding how multiple characteristics of PD change and whether they can be modified by different exercise programs is essential to determining if an exercise program is clinically effective for PD. This study is designed to compare the initial (six months), and then long-term (2 years) effect that 2 different exercise programs (progressive resistance program or flexibility program) have on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease. The goal is to determine which program is most beneficial. Results from this study will be used to determine which exercise program produces the most beneficial effects on neuro-physiological, motor, functional and quality-of-life measures. NOTE: Recruitment for Parkinson's disease participants is now closed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive resistance training
Arm Type
Active Comparator
Arm Description
Subjects will perform between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Arm Title
Modified Fitness Counts
Arm Type
Active Comparator
Arm Description
Subjects will perform between 60 and 90 minutes of modified Fitness Counts two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Intervention Type
Behavioral
Intervention Name(s)
Progressive resistance training
Intervention Description
Exercise twice a week for 2 years doing either progressive resistance training. The The PRE program consisted of 11 strengthening exercises: chest press, latissimus pull downs, reverse flys, double leg press, hip extension, shoulder press, biceps curl, rotary calf (ankle plantar flexion), triceps extension, seated quadriceps extension and back extension.
Intervention Type
Behavioral
Intervention Name(s)
Modified Fitness Counts
Intervention Description
The modified Fitness Counts program was taken from Chapters 2 and 3 of the Parkinson's disease: Fitness Counts booklet and focused on non-progressive stretching, strengthening and balance exercises.
Primary Outcome Measure Information:
Title
Off Medication UPDRS Part III, Motor Subscale Score
Description
UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Secondary Outcome Measure Information:
Title
On Medication UPDRS-III
Description
UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for the UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
L-dopa equivalent-mg/Day
Description
This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Elbow Flexion Strength
Description
This is the MVC for elbow flexion
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Ankle Plantar Flexion Strength
Description
This is a measure of the MVC for ankle plantar flexion strength
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Elbow Extension Strength
Description
This is a measure of the MVC for elbow extension
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Ankle Dorsiflexion Strength
Description
This is a measure of the MVC for ankle dorsiflexion
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions
Description
This is a measure of the percentage of the EMG signal that is contained in different frequency bins during a MVC (elbow flexion/extension; ankle DF/PF), a 50% of MVC elbow fleixon contraction, and a 5 NM elbow flexion contraction.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
The Integral of the First Agonist Burst
Description
The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Magnitude of the First 30 ms of the Agonist Burst
Description
The integral of the first 30 msec of the agonist EMG.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Magnitude of the Antagonist Burst
Description
the area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Magnitude of the Agonist Burst
Description
Magnitude of the agonist burst reflects the amount of agonist activation during movement.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Duration of First Agonist Burst
Description
Time in (ms) for the duration of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Number of Agonist Bursts
Description
This is the number of agonist bursts prior to peak velocity.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Co-contraction During Limb Acceleration
Description
the amount of agonist and antagonist activity present during limb acceleration.
Time Frame
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Qant
Description
The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Time to Peak Velocity
Description
Time of the onset of the movement to peak velocity.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Peak Movement Velocity
Description
This is how fast an individual can perform a 72 degree elbow flexion movement
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Relaxation Time
Description
Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Rise Time
Description
This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Spatiotemporal Gait Analysis
Description
Spatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Distance Walked in 6 Minutes
Description
This is how far an individual can walk in 6 minutes
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Modified Physical Performance Test
Description
This is an overall measure of physical fuction
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Time on the Timed up and go Test
Description
This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Berg Balance Scale Score
Description
This is a overall measure of balance
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Functional Reach
Description
The distance one can reach forward without taking a step.
Time Frame
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Cognitive Function - Stroop Test
Description
This is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Cognitive Function - Brief Test of Attention
Description
This is a cognitive test of an individuals ability to remember number. It is a test of working memory.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Cognitive Function - Digit Span Forward/Backward
Description
This tests a persons ability to remember that were read to them both forward and then backwards.
Time Frame
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Parkinson 's Disease Quality of Life
Description
PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.
Time Frame
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Epworth Sleepiness Scale
Description
The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.
Time Frame
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
Beck's Depression Inventory
Description
This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Time Frame
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
50 ft Walk Time
Description
Time it takes to walk 50 feet
Time Frame
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
50 Foot Walk Speed
Description
The speed that aerson walks over 50 feet
Time Frame
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Title
5 Time Sit to Stand
Description
The time it takes to stand up and sit down five times
Time Frame
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a diagnosis of PD Up to the age of 67 on at least 1 DA drug, may be on several PD medications able to walk for six minutes (may take rest breaks) able to come off their PD medication for testing (12 hour overnight withdrawal of antiparkinsonian medications) able to stay on stable PD medications for at least 6 months live within a 30 mile radius of Chicago Hoehn and Yahr Score: II - III while in the "Off" PD medication state Exclusion Criteria: history of any other neurological disorder as determined by medical history and neurological exam history of a known injury, disease, or other disorder that might interfere with motor function in the proposed experiments a score less than 23 on the Mini-Mental State Examination currently involved in an active, ongoing formal exercise program deep brain stimulation surgery known cardiac problem or significant hypertension depression that may interfere with regular exercise hallucinations or being treated for hallucinations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Corcos, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy Department at the University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26148003
Citation
David FJ, Robichaud JA, Leurgans SE, Poon C, Kohrt WM, Goldman JG, Comella CL, Vaillancourt DE, Corcos DM. Exercise improves cognition in Parkinson's disease: The PRET-PD randomized, clinical trial. Mov Disord. 2015 Oct;30(12):1657-63. doi: 10.1002/mds.26291. Epub 2015 Jul 6.
Results Reference
derived

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The Effect of Exercise on Individuals With Parkinson's Disease

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