Trial Outcomes & Findings for Masked Faces in Parkinson Disease: Mechanism and Treatment (NCT NCT00350402)
NCT ID: NCT00350402
Last Updated: 2012-04-06
Results Overview
Primary outcome is change in entropy score from baseline to immediate completion of 4 week intervention. Entropy is a computer derived index of facial movement that is computed by quantifying changes in pixel intensity as the face moves over a series of video frames. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity (desired). In this condition ("off dopamine), entropy scores were obtained when participants were tested "off" their normal dopamine medications. Off-dopamine testing occurred after a 12-hour overnight washout period.
COMPLETED
PHASE2
44 participants
Baseline and 4 weeks (i.e., immediate after 4-week treatment)
2012-04-06
Participant Flow
Parkinson participants were recruited from the University of Florida Center for Movement Disorders and Neurorestoration. Recruitment began in 2004 and ended in 2009.
Several participants were enrolled, but subsequently excluded (prior to randomization) when it was learned that they had medical conditions that had not initially been divulged or detected (i.e., seizure disorder, "booster" ECT for treatment of depression).
Participant milestones
| Measure |
Inspiratory Muscle Strength Training (IMST)
high intensity respiratory muscle strength training, 75% MIP
|
Sham MST
Low intensity muscle strength training (5% MIP)
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Inspiratory Muscle Strength Training (IMST)
high intensity respiratory muscle strength training, 75% MIP
|
Sham MST
Low intensity muscle strength training (5% MIP)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Masked Faces in Parkinson Disease: Mechanism and Treatment
Baseline characteristics by cohort
| Measure |
Inspiratory Muscle Strength Training (IMST)
n=21 Participants
high intensity respiratory muscle strength training, 75% MIP
|
Sham MST
n=21 Participants
Low intensity muscle strength training (5% MIP)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66.2 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Education
|
16.76 years
STANDARD_DEVIATION 2.57 • n=5 Participants
|
15.52 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
16.14 years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
|
Dementia Rating Scale-2
|
140 Units on a scale
STANDARD_DEVIATION 3.49 • n=5 Participants
|
138 Units on a scale
STANDARD_DEVIATION 4.44 • n=7 Participants
|
139 Units on a scale
STANDARD_DEVIATION 4.07 • n=5 Participants
|
|
Hoehn-Yahr Scale
|
2.1 units on a scale
STANDARD_DEVIATION .301 • n=5 Participants
|
2.29 units on a scale
STANDARD_DEVIATION .463 • n=7 Participants
|
2.19 units on a scale
STANDARD_DEVIATION .397 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks (i.e., immediate after 4-week treatment)Population: All participants who completed baseline, intervention, and post-testing. Two participants, one from each group, dropped out during first week of intervention.
Primary outcome is change in entropy score from baseline to immediate completion of 4 week intervention. Entropy is a computer derived index of facial movement that is computed by quantifying changes in pixel intensity as the face moves over a series of video frames. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity (desired). In this condition ("off dopamine), entropy scores were obtained when participants were tested "off" their normal dopamine medications. Off-dopamine testing occurred after a 12-hour overnight washout period.
Outcome measures
| Measure |
Inspiratory Muscle Strength Training (IMST): 75% MIP
n=20 Participants
High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take "deep breaths" and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff.
|
Sham IMST: 5% MIP
n=20 Participants
The Sham IMST intervention was identical to the "real" intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training.
|
|---|---|---|
|
Change in Facial Entropy Score From Baseline [Off Dopamine Medication]
|
5.649 units on a scale
Standard Deviation 6.66
|
-1.605 units on a scale
Standard Deviation 6.16
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks (i.e., immediate after 4-week intervention)Population: Based on individuals who completed baseline and post-treatment assessment following 4 weeks of intervention. One individual from each treatment group dropped out during the first week of intervention and were not included in analyses.
Outcome is entropy change from baseline to immediate completion of 4 week intervention when participants remained on their normal dosage of dopamine medication. Entropy is quantitative index of facial movement that is computed from changes in pixel intensity as the face moves. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity. Greater expressivity is desired outcome.
Outcome measures
| Measure |
Inspiratory Muscle Strength Training (IMST): 75% MIP
n=20 Participants
High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take "deep breaths" and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff.
|
Sham IMST: 5% MIP
n=20 Participants
The Sham IMST intervention was identical to the "real" intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training.
|
|---|---|---|
|
Change in Facial Entropy Score From Baseline [On Dopamine Medication]
|
3.559 Units on a scale
Standard Deviation 9.995
|
-1.569 Units on a scale
Standard Deviation 4.931
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks (i.e., immediate post-intervention)Population: Participants who completed baseline,intervention, and post-intervention testing. Two individuals, one from each group, dropped out of the study during the first week of intervention.
The PDQ-39 is a widely used quality of life measure that is specific to Parkinson disease. Total raw score on the PDQ-39 ranges from 0 to 156. Higher scores reflect worse quality of life rating. Total score on PDQ-39 was used to compute pre-post treatment changes.
Outcome measures
| Measure |
Inspiratory Muscle Strength Training (IMST): 75% MIP
n=20 Participants
High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take "deep breaths" and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff.
|
Sham IMST: 5% MIP
n=20 Participants
The Sham IMST intervention was identical to the "real" intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training.
|
|---|---|---|
|
Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)
|
1.850 units on a scale
Standard Deviation 10.16
|
-1.550 units on a scale
Standard Deviation 17.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 weeks (i.e., immediate after 4-week intervention)Population: Included participants who underwent baseline, intervention, and post-treatment assessment. Two individuals dropped out during the first week of intervention, one from each intervention group. Additionally, there was faulty data, due to equipment failure for one individual in the sham group, thereby reducing N in this group to 19.
The dependent variable is the change in maximal inspiratory pressure (MIP) from baseline to immediate completion of 4-week intervention. MIP refers to how much air pressure force an individual creates by inhaling through the mouth as hard as possible. This was measured over 5-7 trials by placement of lips around a mouthpiece attached to a calibrated fluke digital pressure gauge. From these trials, an average maximum inspiratory pressure (MIP) was computed. This was done at baseline and post-treatment. Greater MIP changes correspond to greater treatment-related effects of exercise.
Outcome measures
| Measure |
Inspiratory Muscle Strength Training (IMST): 75% MIP
n=20 Participants
High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take "deep breaths" and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff.
|
Sham IMST: 5% MIP
n=19 Participants
The Sham IMST intervention was identical to the "real" intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training.
|
|---|---|---|
|
Change From Baseline in Maximal Inspiratory Pressure (MIP)
|
13.9 units of pressure (cmH20)
Standard Deviation 12.16
|
3.47 units of pressure (cmH20)
Standard Deviation 14.16
|
Adverse Events
Inspiratory Muscle Strength Training (IMST)
Sham MST
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place