Parkinson's Disease
Conditions
Keywords
Parkinson's disease, PD, masked faces, diminished facial expressivity, diminished facial expression, high intensity respiratory muscle strength training, MST
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRespiratory 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.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of idiopathic Parkinson disease * Hoeh-Yahr Stage 1-3 when off medication * Stable and optimal medical regimen for at least 3 months * No previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation) * Participants will include men and women between the ages of 45 and 80 years
Exclusion criteria
* Evidence of dementia based on neurocognitive testing * Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse). Participants who are taking anti-depressants will not be excluded as long as they are not currently depressed (Beck Depression, SCID) * Other neurologic disturbance (e.g., tumor, stroke, traumatic brain injury, epilepsy) or severe chronic medical illness (e.g., HIV, metastatic cancer) * Presence of oro-facial dyskinesias * Previous surgeries to the larynx that result in poor vocal fold closure and/or positive history of head and neck cancer * History of smoking in the past 5 years * Untreated hypertension * Failing a baseline test of pulmonary function during baseline respiratory evaluation * Known respiratory complications such as chronic obstructive pulmonary disease (POCD), asthma * Previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Facial Entropy Score From Baseline [Off Dopamine Medication] | Baseline and 4 weeks (i.e., immediate after 4-week treatment) | 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. |
| Change in Facial Entropy Score From Baseline [On Dopamine Medication] | Baseline and 4 weeks (i.e., immediate after 4-week intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39) | Baseline and 4 weeks (i.e., immediate post-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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Maximal Inspiratory Pressure (MIP) | Baseline and 4 weeks (i.e., immediate after 4-week intervention) | 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. |
Countries
United States
Participant flow
Recruitment details
Parkinson participants were recruited from the University of Florida Center for Movement Disorders and Neurorestoration. Recruitment began in 2004 and ended in 2009.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Inspiratory Muscle Strength Training (IMST) high intensity respiratory muscle strength training, 75% MIP | 21 |
| Sham MST Low intensity muscle strength training (5% MIP) | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Sham MST | Total | Inspiratory Muscle Strength Training (IMST) |
|---|---|---|---|
| Age Continuous | 68.4 years STANDARD_DEVIATION 6.9 | 67.3 years STANDARD_DEVIATION 6.7 | 66.2 years STANDARD_DEVIATION 7.3 |
| Dementia Rating Scale-2 | 138 Units on a scale STANDARD_DEVIATION 4.44 | 139 Units on a scale STANDARD_DEVIATION 4.07 | 140 Units on a scale STANDARD_DEVIATION 3.49 |
| Education | 15.52 years STANDARD_DEVIATION 3.1 | 16.14 years STANDARD_DEVIATION 2.88 | 16.76 years STANDARD_DEVIATION 2.57 |
| Hoehn-Yahr Scale | 2.29 units on a scale STANDARD_DEVIATION 0.463 | 2.19 units on a scale STANDARD_DEVIATION 0.397 | 2.1 units on a scale STANDARD_DEVIATION 0.301 |
| Region of Enrollment United States | 21 participants | 42 participants | 21 participants |
| Sex: Female, Male Female | 8 Participants | 14 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 28 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training (IMST): 75% MIP | Change in Facial Entropy Score From Baseline [Off Dopamine Medication] | 5.649 units on a scale | Standard Deviation 6.66 |
| Sham IMST: 5% MIP | Change in Facial Entropy Score From Baseline [Off Dopamine Medication] | -1.605 units on a scale | Standard Deviation 6.16 |
Comparison: Hypothesis: Parkinson patients assigned to high intensity IMST will show greater improvement in facial movement (entropy) relative to those undergoing Sham IMST.p-value: <0.00195% CI: [3.147, 11.362]t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training (IMST): 75% MIP | Change in Facial Entropy Score From Baseline [On Dopamine Medication] | 3.559 Units on a scale | Standard Deviation 9.995 |
| Sham IMST: 5% MIP | Change in Facial Entropy Score From Baseline [On Dopamine Medication] | -1.569 Units on a scale | Standard Deviation 4.931 |
Comparison: Hypothesis: Facial entropy changes would be greater in IMST group than sham treatment group. Sample size was based on preliminary data suggesting total N of 40 would be adequate for detecting change in entropy (of approximately 50%).p-value: <0.04795% CI: [0.0834, 10.17]t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training (IMST): 75% MIP | Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39) | 1.850 units on a scale | Standard Deviation 10.16 |
| Sham IMST: 5% MIP | Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39) | -1.550 units on a scale | Standard Deviation 17.57 |
Comparison: Hypothesis: Scores on PDQ-39 would show bigger change for the IMST group than the Sham treatment group. The sample size was not powered for the PDQ-39 (but rather for the primary outcome variable).p-value: <0.45995% CI: [-16.41, 3.68]t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training (IMST): 75% MIP | Change From Baseline in Maximal Inspiratory Pressure (MIP) | 13.9 units of pressure (cmH20) | Standard Deviation 12.16 |
| Sham IMST: 5% MIP | Change From Baseline in Maximal Inspiratory Pressure (MIP) | 3.47 units of pressure (cmH20) | Standard Deviation 14.16 |
Comparison: Hypothesis: Changes in MIP following treatment would be greater for participants in the IMST versus the Sham treatment group. This is a validity check on for the IMST intervention.p-value: <0.01895% CI: [1.874, 18.978]t-test, 2 sided