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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS050633 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Muscle Strength Training | Active Comparator | 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. |
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| Sham MST | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory muscle strength training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and 4 weeks (i.e., immediate after 4-week intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4 weeks (i.e., immediate post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Bowers, Ph.D. | Professor and Area Head, Department of Clinical and Health Psychology, University of Florida | Principal Investigator |
| Christine Sapienza, Ph.D. | Professor and Chair, Department of Communication Sciences and Disorders, University of Florida | Principal Investigator |
| Michael S. Okun, M.D. | Assistant Professor, Co-Director Movement Disorders Program, Medical Director, National Parkinson Foundation, Department of Neurology | Principal Investigator |
| Hubert Fernandez, M.D. | Associate Professor and Director of Clinical Trials, Movement Disorder Program, Department of Neurology, University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida | Gainesville | Florida | 32601 | United States |
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).
Parkinson participants were recruited from the University of Florida Center for Movement Disorders and Neurorestoration. Recruitment began in 2004 and ended in 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inspiratory Muscle Strength Training (IMST) | high intensity respiratory muscle strength training, 75% MIP |
| FG001 | Sham MST | Low intensity muscle strength training (5% MIP) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Inspiratory Muscle Strength Training (IMST) | high intensity respiratory muscle strength training, 75% MIP |
| BG001 | Sham MST | Low intensity muscle strength training (5% MIP) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who completed baseline, intervention, and post-testing. Two participants, one from each group, dropped out during first week of intervention. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks (i.e., immediate after 4-week treatment) |
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Data collected for 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inspiratory Muscle Strength Training (IMST) | high intensity respiratory muscle strength training, 75% MIP |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dawn Bowers | University of Florida | (352) 392-3450 | dawnbowers@phhp.ufl.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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| Baseline and 4 weeks (i.e., immediate after 4-week intervention) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Education refers to total years in school, up to a maxium of 20 years | Mean | Standard Deviation | years |
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| Dementia Rating Scale-2 | The DRS-2 is a cognitive screening measure for ruling out dementia. Raw scores range from 0 to 144, where higher scores reflect better performance. Scores below 130 are associated with significant cognitive disturbance. | Mean | Standard Deviation | Units on a scale |
|
| Hoehn-Yahr Scale | This scale is used to stage the severity of Parkinson disease symptoms. The scale ranges from Stages 0 to 5. Higher scores (i.e., 5) reflect more severe stage of Parkinson disease. | Mean | Standard Deviation | units on a scale |
|
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. |
| OG001 | Sham IMST: 5% MIP | 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. |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks (i.e., immediate post-intervention) |
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| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | units of pressure (cmH20) | Baseline and 4 weeks (i.e., immediate after 4-week intervention) |
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|
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 4 weeks (i.e., immediate after 4-week intervention) |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Sham MST | Low intensity muscle strength training (5% MIP) | 0 | 21 | 0 | 21 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D026741 |
| Physical Therapy Modalities |