A Phase 2 interventional study of Respiratory muscle strength training in Parkinson's Disease, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-06.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
The purpose of this study is to examine the effectiveness of high intensity respiratory muscle strength training in treating blunted facial expression in people with Parkinson disease.
Facial expressions are complex signals that last only a few minutes and are important for communicating intention, motivation, and emotional states. In humans, a variety of neurological and psychiatric conditions alter the tendency to use facial signals. One of the main symptoms of Parkinson disease (PD) is diminished facial expressivity or "masked facies," which refers to the expressionless appearance of individuals with the disorder.
Unfortunately, little progress has been made over the years regarding the basis of "masked faces" or strategies that might improve facial expressivity among individuals with PD. This is unfortunate because the particular symptom can have significant medical and social consequences ranging from misdiagnosis of depression to the misattribution of negative emotional states and motivation by family members and healthcare providers.
The goal of this trial is to study the effectiveness of a novel, behavioral treatment approach-high intensity respiratory muscle strength training (MST)-for blunting of facial expressions in people with PD. The MST device, a mouthpiece that the participant uses to inspire against resistance, may improve the strength and mobility of muscles around the mouth that are involved in forming facial expressions.
Study participation includes screening, baseline evaluations, 4 weeks of behavioral intervention, immediate post-treatment followup, and a 3-month follow-up. Participants will be randomly assigned to take part in high intensity respiratory MST, or a Sham MST. Participation in the study will last for approximately 5 months.
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This arm involved high intensity muscle strength training at 75% maximum inspiratory pressure (MIP). Training took place for 4 weeks, 5 days a week. Each daily session involved 5 sets of breathing exercises that required participants to take deep breaths (i.e., inspire) using use a breathing device. Settings on the breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP)using a specialized breathing gauge. The MIP was determined at the beginning of each week and the training device was adjusted and set at 75% MIP. Exercises took place in home setting, with weekly visit by staff. Participants kept daily exercise log.
Behavioral: Respiratory muscle strength training
This arm (low intensity MST) was identical to the real intervention in all ways except that the training device was set at 5% maximum inspiratory pressure (MIP). Thus less muscle and breathing effort was required during this sham treatment.
Behavioral: Respiratory muscle strength training
The Muscle Stength Training (MST)device is a mouthpiece that the participant uses to inspire against controlled resistance; Intervention involves use of this device for breathing exercises over 4 week period, 5 days a week, approximately 20 minutes/day.
Also known as: Respiratory Training, Inspiratory Training, Expiratory Training
Change in Facial Entropy Score From Baseline [Off Dopamine Medication]
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.
Time frame: Baseline and 4 weeks (i.e., immediate after 4-week treatment)
Change in Facial Entropy Score From Baseline [On Dopamine Medication]
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.
Time frame: Baseline and 4 weeks (i.e., immediate after 4-week intervention)
Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)
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.
Time frame: Baseline and 4 weeks (i.e., immediate post-intervention)
Change From Baseline in Maximal Inspiratory Pressure (MIP)
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.
Time frame: Baseline and 4 weeks (i.e., immediate after 4-week intervention)
Parkinson participants were recruited from the University of Florida Center for Movement Disorders and Neurorestoration. Recruitment began in 2004 and ended in 2009.
| Milestone | Inspiratory Muscle Strength Training (IMST) | Sham MST |
|---|---|---|
| Started | 21 | 21 |
| Completed | 20 | 20 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
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.
| units on a scale | Inspiratory Muscle Strength Training (IMST): 75% MIP | Sham IMST: 5% MIP |
|---|---|---|
| Change in Facial Entropy Score From Baseline [Off Dopamine Medication] | 5.649 ± 6.66 | -1.605 ± 6.16 |
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.
| units on a scale | Inspiratory Muscle Strength Training (IMST): 75% MIP | Sham IMST: 5% MIP |
|---|---|---|
| Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39) | 1.850 ± 10.16 | -1.550 ± 17.57 |
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.
| units of pressure (cmH20) | Inspiratory Muscle Strength Training (IMST): 75% MIP | Sham IMST: 5% MIP |
|---|---|---|
| Change From Baseline in Maximal Inspiratory Pressure (MIP) | 13.9 ± 12.16 | 3.47 ± 14.16 |
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.
| Units on a scale | Inspiratory Muscle Strength Training (IMST): 75% MIP | Sham IMST: 5% MIP |
|---|---|---|
| Change in Facial Entropy Score From Baseline [On Dopamine Medication] | 3.559 ± 9.995 | -1.569 ± 4.931 |
Collected over Data collected for 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inspiratory Muscle Strength Training (IMST) | — | 0/21 (0%) | 0/21 (0%) |
| Sham MST | — | 0/21 (0%) | 0/21 (0%) |
| Age Continuous(years) | Inspiratory Muscle Strength Training (IMST) | Sham MST | Total |
|---|---|---|---|
| Mean | 66.2 ± 7.3 | 68.4 ± 6.9 | 67.3 ± 6.7 |
| Sex: Female, Male(Participants) | Inspiratory Muscle Strength Training (IMST) | Sham MST | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 15 | 13 | 28 |
| Region of Enrollment(participants) | Inspiratory Muscle Strength Training (IMST) | Sham MST | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
| Education(years) | Inspiratory Muscle Strength Training (IMST) | Sham MST | Total |
|---|---|---|---|
| Mean | 16.76 ± 2.57 | 15.52 ± 3.1 | 16.14 ± 2.88 |
| Dementia Rating Scale-2(Units on a scale) | Inspiratory Muscle Strength Training (IMST) | Sham MST | Total |
|---|---|---|---|
| Mean | 140 ± 3.49 | 138 ± 4.44 | 139 ± 4.07 |
| Hoehn-Yahr Scale(units on a scale) | Inspiratory Muscle Strength Training (IMST) | Sham MST | Total |
|---|---|---|---|
| Mean | 2.1 ± .301 | 2.29 ± .463 | 2.19 ± .397 |
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