Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00350402
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2006-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Masked Faces in Parkinson Disease: Mechanism and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dawnbowers@phhp.ufl.edu', 'phone': '(352) 392-3450', 'title': 'Dr. Dawn Bowers', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data collected for 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Inspiratory Muscle Strength Training (IMST)', 'description': 'high intensity respiratory muscle strength training, 75% MIP', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham MST', 'description': 'Low intensity muscle strength training (5% MIP)', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Facial Entropy Score From Baseline [Off Dopamine Medication]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inspiratory Muscle Strength Training (IMST): 75% MIP', 'description': '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.'}, {'id': 'OG001', 'title': 'Sham IMST: 5% MIP', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.649', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '-1.605', 'spread': '6.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.254', 'ciLowerLimit': '3.147', 'ciUpperLimit': '11.362', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.028', 'estimateComment': "Treatment effect size: Cohen's D =1.142", 'groupDescription': 'Hypothesis: Parkinson patients assigned to high intensity IMST will show greater improvement in facial movement (entropy) relative to those undergoing Sham IMST.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'df = 38; t = 3.576', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (i.e., immediate after 4-week treatment)', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed baseline, intervention, and post-testing. Two participants, one from each group, dropped out during first week of intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inspiratory Muscle Strength Training (IMST): 75% MIP', 'description': 'Same as previously described. 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.'}, {'id': 'OG001', 'title': 'Sham IMST: 5% MIP', 'description': 'Same as previously described. 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.850', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '-1.550', 'spread': '17.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.459', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.36', 'ciLowerLimit': '-16.41', 'ciUpperLimit': '3.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.955', 'groupDescription': '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).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (i.e., immediate post-intervention)', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Maximal Inspiratory Pressure (MIP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inspiratory Muscle Strength Training (IMST): 75% MIP', 'description': 'high intensity respiratory muscle strength training, 75% MIP'}, {'id': 'OG001', 'title': 'Sham IMST: 5% MIP', 'description': 'Low intensity muscle strength training (5% MIP)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '12.16', 'groupId': 'OG000'}, {'value': '3.47', 'spread': '14.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.426', 'ciLowerLimit': '1.874', 'ciUpperLimit': '18.978', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.221', 'groupDescription': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 't-value = 2.47, with 37 df', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (i.e., immediate after 4-week intervention)', 'description': '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.', 'unitOfMeasure': 'units of pressure (cmH20)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change in Facial Entropy Score From Baseline [On Dopamine Medication]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inspiratory Muscle Strength Training (IMST): 75% MIP', 'description': 'Same as previously described. This intervention involves high intensity respiratory muscle strength training over 4 week period, 5 days a week, with training device set at 75% maximal inspiratory pressure (MIP). The MIP is determined weekly and the training device recalibrated to take into account changes.'}, {'id': 'OG001', 'title': 'Sham IMST: 5% MIP', 'description': 'This intervention is identical in all ways to "real" treatment, except that training device requires less inspiratory effort. The training device is set at 5% MIP. )'}], 'classes': [{'categories': [{'measurements': [{'value': '3.559', 'spread': '9.995', 'groupId': 'OG000'}, {'value': '-1.569', 'spread': '4.931', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.129', 'ciLowerLimit': '.0834', 'ciUpperLimit': '10.17', 'pValueComment': 'No adjustment necessary', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.492', 'groupDescription': '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%).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '38 df, t= 2.058 However, due to inequality of variance (Levine test), the adjusted p-value = \\<0.049, and adjusted df = 27.3', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks (i.e., immediate after 4-week intervention)', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inspiratory Muscle Strength Training (IMST)', 'description': 'high intensity respiratory muscle strength training, 75% MIP'}, {'id': 'FG001', 'title': 'Sham MST', 'description': 'Low intensity muscle strength training (5% MIP)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Parkinson participants were recruited from the University of Florida Center for Movement Disorders and Neurorestoration. Recruitment began in 2004 and ended in 2009.', 'preAssignmentDetails': '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inspiratory Muscle Strength Training (IMST)', 'description': 'high intensity respiratory muscle strength training, 75% MIP'}, {'id': 'BG001', 'title': 'Sham MST', 'description': 'Low intensity muscle strength training (5% MIP)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '67.3', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'categories': [{'measurements': [{'value': '16.76', 'spread': '2.57', 'groupId': 'BG000'}, {'value': '15.52', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '16.14', 'spread': '2.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Education refers to total years in school, up to a maxium of 20 years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dementia Rating Scale-2', 'classes': [{'categories': [{'measurements': [{'value': '140', 'spread': '3.49', 'groupId': 'BG000'}, {'value': '138', 'spread': '4.44', 'groupId': 'BG001'}, {'value': '139', 'spread': '4.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hoehn-Yahr Scale', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '.301', 'groupId': 'BG000'}, {'value': '2.29', 'spread': '.463', 'groupId': 'BG001'}, {'value': '2.19', 'spread': '.397', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-04', 'studyFirstSubmitDate': '2006-07-05', 'resultsFirstSubmitDate': '2012-02-06', 'studyFirstSubmitQcDate': '2006-07-05', 'lastUpdatePostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-07', 'studyFirstPostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Maximal Inspiratory Pressure (MIP)', 'timeFrame': 'Baseline and 4 weeks (i.e., immediate after 4-week intervention)', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change in Facial Entropy Score From Baseline [Off Dopamine Medication]', 'timeFrame': 'Baseline and 4 weeks (i.e., immediate after 4-week treatment)', 'description': '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.'}, {'measure': 'Change in Facial Entropy Score From Baseline [On Dopamine Medication]', 'timeFrame': 'Baseline and 4 weeks (i.e., immediate after 4-week intervention)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)', 'timeFrame': 'Baseline and 4 weeks (i.e., immediate post-intervention)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'PD', 'masked faces', 'diminished facial expressivity', 'diminished facial expression', 'high intensity respiratory muscle strength training', 'MST'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nUnfortunately, 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.\n\nThe 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.\n\nStudy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A clinical diagnosis of idiopathic Parkinson disease\n* Hoeh-Yahr Stage 1-3 when off medication\n* Stable and optimal medical regimen for at least 3 months\n* No previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation)\n* Participants will include men and women between the ages of 45 and 80 years\n\nExclusion Criteria:\n\n* Evidence of dementia based on neurocognitive testing\n* 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)\n* Other neurologic disturbance (e.g., tumor, stroke, traumatic brain injury, epilepsy) or severe chronic medical illness (e.g., HIV, metastatic cancer)\n* Presence of oro-facial dyskinesias\n* Previous surgeries to the larynx that result in poor vocal fold closure and/or positive history of head and neck cancer\n* History of smoking in the past 5 years\n* Untreated hypertension\n* Failing a baseline test of pulmonary function during baseline respiratory evaluation\n* Known respiratory complications such as chronic obstructive pulmonary disease (POCD), asthma\n* Previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation)"}, 'identificationModule': {'nctId': 'NCT00350402', 'briefTitle': 'Masked Faces in Parkinson Disease: Mechanism and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Masked Faces in Parkinson Disease: A Randomized Double-blind Sham-treatment Controlled Clinical Trial of High Intensity Respiratory Muscle Strength Training (MST) for Treatment of Reduced Facial Expression in Parkinson Disease', 'orgStudyIdInfo': {'id': 'R01NS050633', 'link': 'https://reporter.nih.gov/quickSearch/R01NS050633', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01NS050633', 'link': 'https://reporter.nih.gov/quickSearch/R01NS050633', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Intensity Muscle Strength Training', 'description': "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.", 'interventionNames': ['Behavioral: Respiratory muscle strength training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham MST', 'description': '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.', 'interventionNames': ['Behavioral: Respiratory muscle strength training']}], 'interventions': [{'name': 'Respiratory muscle strength training', 'type': 'BEHAVIORAL', 'otherNames': ['Respiratory Training', 'Inspiratory Training', 'Expiratory Training'], 'description': '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.', 'armGroupLabels': ['High Intensity Muscle Strength Training', 'Sham MST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32601', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Dawn Bowers, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and Area Head, Department of Clinical and Health Psychology, University of Florida'}, {'name': 'Christine Sapienza, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and Chair, Department of Communication Sciences and Disorders, University of Florida'}, {'name': 'Michael S. Okun, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor, Co-Director Movement Disorders Program, Medical Director, National Parkinson Foundation, Department of Neurology'}, {'name': 'Hubert Fernandez, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor and Director of Clinical Trials, Movement Disorder Program, Department of Neurology, University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}