Parkinson's Disease
Conditions
Keywords
Parkinson's disease, exercise
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Off Medication UPDRS Part III, Motor Subscale Score | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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
| Measure | Time frame | Description |
|---|---|---|
| L-dopa equivalent-mg/Day | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications. |
| Elbow Flexion Strength | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is the MVC for elbow flexion |
| Ankle Plantar Flexion Strength | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is a measure of the MVC for ankle plantar flexion strength |
| Elbow Extension Strength | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is a measure of the MVC for elbow extension |
| Ankle Dorsiflexion Strength | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | The integral of the first 30 msec of the agonist EMG. |
| Magnitude of the Antagonist Burst | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | Magnitude of the agonist burst reflects the amount of agonist activation during movement. |
| Duration of First Agonist Burst | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is the number of agonist bursts prior to peak velocity. |
| Co-contraction During Limb Acceleration | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | the amount of agonist and antagonist activity present during limb acceleration. |
| Qant | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement |
| Time to Peak Velocity | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | Time of the onset of the movement to peak velocity. |
| Peak Movement Velocity | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is how fast an individual can perform a 72 degree elbow flexion movement |
| On Medication UPDRS-III | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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. |
| Rise Time | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is how far an individual can walk in 6 minutes |
| Modified Physical Performance Test | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is an overall measure of physical fuction |
| Time on the Timed up and go Test | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is a overall measure of balance |
| Functional Reach | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | The distance one can reach forward without taking a step. |
| Cognitive Function - Stroop Test | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This tests a persons ability to remember that were read to them both forward and then backwards. |
| Parkinson 's Disease Quality of Life | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease. |
| Epworth Sleepiness Scale | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness. |
| Beck's Depression Inventory | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression. |
| 50 ft Walk Time | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | Time it takes to walk 50 feet |
| 50 Foot Walk Speed | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | The speed that aerson walks over 50 feet |
| 5 Time Sit to Stand | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | The time it takes to stand up and sit down five times |
| Relaxation Time | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC |
Countries
United States
Participant flow
Recruitment details
Patients with Parkinson's disease, confirmed by a Movement Disorders specialist, were self-referred or recruited from Rush University Medical Center (RUMC) between 9/2007 and 7/2011 for PD subjects. Patients were evaluated at the University of Illinois at Chicago (UIC).
Pre-assignment details
Patients were 50 to 67 years; on stable PD meds; and can walk for 6 minutes. Patients were ineligible if they had a neurological history other than PD; significant arthritis; failed the Physical Activity Readiness Questionnaire; had cognitive impairment (indicated by Mini-Mental State Examination score); actively exercising; or had surgery for PD.
Participants by arm
| Arm | Count |
|---|---|
| 1 Progressive Resistance Training 25 PD Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were 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.
Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training. | 26 |
| 2 Flexibility Training 25 PD subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were 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.
Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Did not want to come off medication | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Medical complications | 1 | 3 |
| Overall Study | Moved out of state | 1 | 0 |
| Overall Study | Transportation issues | 1 | 0 |
| Overall Study | Underwent DBS | 2 | 2 |
Baseline characteristics
| Characteristic | 1 Progressive Resistance Training | 2 Flexibility Training | Total |
|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 5.6 | 59.0 years STANDARD_DEVIATION 4.6 | 58.8 years STANDARD_DEVIATION 5.1 |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 1 / 26 |
| serious Total, serious adverse events | 8 / 25 | 6 / 26 |
Outcome results
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Fitness Counts | Off Medication UPDRS Part III, Motor Subscale Score | baseline | 34.7 units on a scale | Standard Deviation 11.5 |
| Modified Fitness Counts | Off Medication UPDRS Part III, Motor Subscale Score | 18 month | 32.8 units on a scale | Standard Deviation 12.3 |
| Modified Fitness Counts | Off Medication UPDRS Part III, Motor Subscale Score | 12 month | 32.8 units on a scale | Standard Deviation 12.4 |
| Modified Fitness Counts | Off Medication UPDRS Part III, Motor Subscale Score | 24 month | 34.0 units on a scale | Standard Deviation 12.6 |
| Modified Fitness Counts | Off Medication UPDRS Part III, Motor Subscale Score | 6 month | 29.3 units on a scale | Standard Deviation 12.2 |
| Progressive Resistance Exercise | Off Medication UPDRS Part III, Motor Subscale Score | 24 month | 25.8 units on a scale | Standard Deviation 10.6 |
| Progressive Resistance Exercise | Off Medication UPDRS Part III, Motor Subscale Score | 6 month | 28.0 units on a scale | Standard Deviation 10.9 |
| Progressive Resistance Exercise | Off Medication UPDRS Part III, Motor Subscale Score | 12 month | 28.4 units on a scale | Standard Deviation 10.8 |
| Progressive Resistance Exercise | Off Medication UPDRS Part III, Motor Subscale Score | 18 month | 28.6 units on a scale | Standard Deviation 9.4 |
| Progressive Resistance Exercise | Off Medication UPDRS Part III, Motor Subscale Score | baseline | 34.5 units on a scale | Standard Deviation 11.9 |
50 Foot Walk Speed
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
50 ft Walk Time
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
5 Time Sit to Stand
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
Ankle Dorsiflexion Strength
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
Ankle Plantar Flexion Strength
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
Beck's Depression Inventory
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
Berg Balance Scale Score
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
Co-contraction During Limb Acceleration
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
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Cognitive Function - Digit Span Forward/Backward
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
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Distance Walked in 6 Minutes
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
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
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Elbow Extension Strength
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
Elbow Flexion Strength
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
Epworth Sleepiness Scale
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
Functional Reach
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
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Fitness Counts | L-dopa equivalent-mg/Day | 6 month | 741.2 mg/day | Standard Deviation 443.5 |
| Modified Fitness Counts | L-dopa equivalent-mg/Day | 18 month | 907.9 mg/day | Standard Deviation 546.9 |
| Modified Fitness Counts | L-dopa equivalent-mg/Day | Baseline | 704.5 mg/day | Standard Deviation 405.3 |
| Modified Fitness Counts | L-dopa equivalent-mg/Day | 24 month | 934.1 mg/day | Standard Deviation 557.2 |
| Modified Fitness Counts | L-dopa equivalent-mg/Day | 12 month | 772.2 mg/day | Standard Deviation 472.7 |
| Progressive Resistance Exercise | L-dopa equivalent-mg/Day | 24 month | 753.6 mg/day | Standard Deviation 369.4 |
| Progressive Resistance Exercise | L-dopa equivalent-mg/Day | 6 month | 619.0 mg/day | Standard Deviation 370.6 |
| Progressive Resistance Exercise | L-dopa equivalent-mg/Day | 12 month | 638.1 mg/day | Standard Deviation 352.2 |
| Progressive Resistance Exercise | L-dopa equivalent-mg/Day | 18 month | 691.4 mg/day | Standard Deviation 384.5 |
| Progressive Resistance Exercise | L-dopa equivalent-mg/Day | Baseline | 597.8 mg/day | Standard Deviation 355.2 |
Magnitude of the Agonist Burst
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
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Magnitude of the First 30 ms of the Agonist Burst
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
Modified Physical Performance Test
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
Number of Agonist Bursts
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
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Fitness Counts | On Medication UPDRS-III | 6 month | 17.7 units on a scale | Standard Deviation 8.6 |
| Modified Fitness Counts | On Medication UPDRS-III | 18 month | 18.1 units on a scale | Standard Deviation 9.7 |
| Modified Fitness Counts | On Medication UPDRS-III | 12 month | 19.1 units on a scale | Standard Deviation 8.4 |
| Modified Fitness Counts | On Medication UPDRS-III | 24 month | 19.3 units on a scale | Standard Deviation 9.7 |
| Modified Fitness Counts | On Medication UPDRS-III | Baseline | 20.9 units on a scale | Standard Deviation 8 |
| Progressive Resistance Exercise | On Medication UPDRS-III | 24 month | 17.9 units on a scale | Standard Deviation 8.7 |
| Progressive Resistance Exercise | On Medication UPDRS-III | Baseline | 21.6 units on a scale | Standard Deviation 10.1 |
| Progressive Resistance Exercise | On Medication UPDRS-III | 6 month | 19.1 units on a scale | Standard Deviation 9 |
| Progressive Resistance Exercise | On Medication UPDRS-III | 12 month | 19.4 units on a scale | Standard Deviation 8.5 |
| Progressive Resistance Exercise | On Medication UPDRS-III | 18 month | 18.4 units on a scale | Standard Deviation 6.5 |
Parkinson 's Disease Quality of Life
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
Peak Movement Velocity
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
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Qant
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
Relaxation Time
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
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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.
Time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Time to Peak Velocity
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