Trial Outcomes & Findings for The Effect of Exercise on Individuals With Parkinson's Disease (NCT NCT00591344)
NCT ID: NCT00591344
Last Updated: 2015-03-05
Results Overview
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.
COMPLETED
NA
51 participants
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
2015-03-05
Participant Flow
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).
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.
Participant milestones
| Measure |
1 Progressive Resistance Training
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.
|
2 Modified Fitness Counts
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
Completed the 6 Month Test
|
24
|
24
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
1 Progressive Resistance Training
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.
|
2 Modified Fitness Counts
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.
|
|---|---|---|
|
Overall Study
Transportation issues
|
1
|
0
|
|
Overall Study
Moved out of state
|
1
|
0
|
|
Overall Study
Medical complications
|
1
|
3
|
|
Overall Study
Underwent DBS
|
2
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Did not want to come off medication
|
0
|
1
|
Baseline Characteristics
The Effect of Exercise on Individuals With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
1 Progressive Resistance Training
n=26 Participants
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.
|
2 Flexibility Training
n=25 Participants
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.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodUPDRS 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.
Outcome measures
| Measure |
Modified Fitness Counts
n=24 Participants
Baseline Assessment- off medication UPDRS part III, motor subscale score
|
Progressive Resistance Exercise
n=24 Participants
Baseline Assessment - off medication UPDRS part III, motor subscale score
|
|---|---|---|
|
Off Medication UPDRS Part III, Motor Subscale Score
baseline
|
34.7 units on a scale
Standard Deviation 11.5
|
34.5 units on a scale
Standard Deviation 11.9
|
|
Off Medication UPDRS Part III, Motor Subscale Score
6 month
|
29.3 units on a scale
Standard Deviation 12.2
|
28.0 units on a scale
Standard Deviation 10.9
|
|
Off Medication UPDRS Part III, Motor Subscale Score
12 month
|
32.8 units on a scale
Standard Deviation 12.4
|
28.4 units on a scale
Standard Deviation 10.8
|
|
Off Medication UPDRS Part III, Motor Subscale Score
18 month
|
32.8 units on a scale
Standard Deviation 12.3
|
28.6 units on a scale
Standard Deviation 9.4
|
|
Off Medication UPDRS Part III, Motor Subscale Score
24 month
|
34.0 units on a scale
Standard Deviation 12.6
|
25.8 units on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodUPDRS 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.
Outcome measures
| Measure |
Modified Fitness Counts
n=24 Participants
Baseline Assessment- off medication UPDRS part III, motor subscale score
|
Progressive Resistance Exercise
n=24 Participants
Baseline Assessment - off medication UPDRS part III, motor subscale score
|
|---|---|---|
|
On Medication UPDRS-III
12 month
|
19.1 units on a scale
Standard Deviation 8.4
|
19.4 units on a scale
Standard Deviation 8.5
|
|
On Medication UPDRS-III
Baseline
|
20.9 units on a scale
Standard Deviation 8.0
|
21.6 units on a scale
Standard Deviation 10.1
|
|
On Medication UPDRS-III
6 month
|
17.7 units on a scale
Standard Deviation 8.6
|
19.1 units on a scale
Standard Deviation 9.0
|
|
On Medication UPDRS-III
18 month
|
18.1 units on a scale
Standard Deviation 9.7
|
18.4 units on a scale
Standard Deviation 6.5
|
|
On Medication UPDRS-III
24 month
|
19.3 units on a scale
Standard Deviation 9.7
|
17.9 units on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.
Outcome measures
| Measure |
Modified Fitness Counts
n=24 Participants
Baseline Assessment- off medication UPDRS part III, motor subscale score
|
Progressive Resistance Exercise
n=24 Participants
Baseline Assessment - off medication UPDRS part III, motor subscale score
|
|---|---|---|
|
L-dopa equivalent-mg/Day
Baseline
|
704.5 mg/day
Standard Deviation 405.3
|
597.8 mg/day
Standard Deviation 355.2
|
|
L-dopa equivalent-mg/Day
6 month
|
741.2 mg/day
Standard Deviation 443.5
|
619.0 mg/day
Standard Deviation 370.6
|
|
L-dopa equivalent-mg/Day
12 month
|
772.2 mg/day
Standard Deviation 472.7
|
638.1 mg/day
Standard Deviation 352.2
|
|
L-dopa equivalent-mg/Day
18 month
|
907.9 mg/day
Standard Deviation 546.9
|
691.4 mg/day
Standard Deviation 384.5
|
|
L-dopa equivalent-mg/Day
24 month
|
934.1 mg/day
Standard Deviation 557.2
|
753.6 mg/day
Standard Deviation 369.4
|
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is the MVC for elbow flexion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is a measure of the MVC for ankle plantar flexion strength
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is a measure of the MVC for elbow extension
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is a measure of the MVC for ankle dorsiflexion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThe Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThe integral of the first 30 msec of the agonist EMG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodthe area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodMagnitude of the agonist burst reflects the amount of agonist activation during movement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodTime 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is the number of agonist bursts prior to peak velocity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained during initial evaluation & then every 6 six months to end of 2-yr training periodthe amount of agonist and antagonist activity present during limb acceleration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThe integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodTime of the onset of the movement to peak velocity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is how fast an individual can perform a 72 degree elbow flexion movement
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodTime for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodSpatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is how far an individual can walk in 6 minutes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is an overall measure of physical fuction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is a overall measure of balance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThe distance one can reach forward without taking a step.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is a cognitive test of an individuals ability to remember number. It is a test of working memory.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis tests a persons ability to remember that were read to them both forward and then backwards.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained during initial evaluation & then every 6 six months to end of 2-yr training periodPDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThe Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThis is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained during initial evaluation & then every 6 six months to end of 2-yr training periodTime it takes to walk 50 feet
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThe speed that aerson walks over 50 feet
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Obtained during initial evaluation & then every 6 six months to end of 2-yr training periodThe time it takes to stand up and sit down five times
Outcome measures
Outcome data not reported
Adverse Events
1 Progressive Resistance Training
2 Modified Fitness Counts
Serious adverse events
| Measure |
1 Progressive Resistance Training
n=25 participants at risk
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.
|
2 Modified Fitness Counts
n=26 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Passed away
|
0.00%
0/25 • SAE's and AE's were collected for 2 years for each study participant.
|
3.8%
1/26 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Nervous system disorders
DBS surgery
|
8.0%
2/25 • Number of events 2 • SAE's and AE's were collected for 2 years for each study participant.
|
7.7%
2/26 • Number of events 2 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Musculoskeletal and connective tissue disorders
ALS
|
0.00%
0/25 • SAE's and AE's were collected for 2 years for each study participant.
|
3.8%
1/26 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/25 • SAE's and AE's were collected for 2 years for each study participant.
|
3.8%
1/26 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Gastrointestinal disorders
Bowel obstruction
|
4.0%
1/25 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
0.00%
0/26 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Musculoskeletal and connective tissue disorders
Elbow pain
|
4.0%
1/25 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
0.00%
0/26 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Musculoskeletal and connective tissue disorders
Back surgery
|
0.00%
0/25 • SAE's and AE's were collected for 2 years for each study participant.
|
3.8%
1/26 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Musculoskeletal and connective tissue disorders
Bilateral hip replacement
|
4.0%
1/25 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
0.00%
0/26 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Musculoskeletal and connective tissue disorders
unilateral knee replacement
|
4.0%
1/25 • Number of events 2 • SAE's and AE's were collected for 2 years for each study participant.
|
0.00%
0/26 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Musculoskeletal and connective tissue disorders
Knee surgery
|
4.0%
1/25 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
0.00%
0/26 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
4.0%
1/25 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
0.00%
0/26 • SAE's and AE's were collected for 2 years for each study participant.
|
|
Musculoskeletal and connective tissue disorders
Foot surgery
|
4.0%
1/25 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
0.00%
0/26 • SAE's and AE's were collected for 2 years for each study participant.
|
Other adverse events
| Measure |
1 Progressive Resistance Training
n=25 participants at risk
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.
|
2 Modified Fitness Counts
n=26 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Wrist pain
|
0.00%
0/25 • SAE's and AE's were collected for 2 years for each study participant.
|
3.8%
1/26 • Number of events 1 • SAE's and AE's were collected for 2 years for each study participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place