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| Name | Class |
|---|---|
| University of Florida | OTHER |
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Respiratory difficulty is one of the primary factors leading to death in patients with Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating diseases that cause difficulties in breathing, airway protection and swallowing. Patients with PD and MS typically become sedentary and lose endurance, maximal fitness levels and overall pulmonary function. Much of the research focus has been on the motor symptoms of PD and MS yet the pulmonary and swallowing complications are perhaps ultimately the most important disability as the diseases progress. The inability to generate adequate respiratory pressure is responsible for reduced cough magnitudes and cough response times. Cough is critical for the clearance of foreign materials in the airway helping to reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough function an increased risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are a number of promising outcomes from an expiratory strength-training program. By increasing expiratory muscle strength and expiratory pressure generation, effective breathing, clearance of the airway, and improved swallowing can occur. These explicit outcomes are predicted based on our experience with the use of an innovative device-driven, home-based expiratory strength training program focused on the expiratory muscles of respiration. This project focuses on following patients with PD and MS for an initial 5 weeks of strength training and them testing the outcome of a caregiver program for maintaining treatment effects.
The proposed investigation will:
Determine if 5 weeks of Expiratory Muscle Strength Training (EMST) increases maximal expiratory driving pressure (MEP) and improves swallow, cough and breathing function in individuals with PD and MS. Following the post assessment of the 5 week EMST program we will then evaluate three different modules for monitoring the continuation of the treatment while assessing patient quality of life and caregiver burden/satisfaction. This will help us determine if one particular home training method results in different physiological and functional outcomes.
Aim 1. Determine the effects of an EMST program on swallow function, voluntary cough production and breathing function in individuals with PD and MS identified as below normal limits for their age and sex (via physiological measures).
Hypothesis 1: There will significant and positive treatment effects following 5 weeks of EMST on the measures of swallow, cough production and breathing function in those with PD and MS following 5 weeks of treatment.
Aim 2: Determine the outcome of three uniquely structured home treatment monitoring programs in maintaining the EMST post treatment effect for patients with MS and PD. These programs are referred to as: Education Module (A), Question Only (B), and Education Module plus Question (C). The monitoring system will be provided by VitelNet, a leading provider of home health monitoring, clinician-based telemedicine Hypothesis 2: Program C will provide greater maintenance of the EMST treatment effect for both patient groups compared to programs A and B.
Aim 3: Determine the effects of the home monitoring programs for improving patient quality of life and caregiver burden/satisfaction.
Hypothesis 3: Program C will provide greater improvements in patient quality of life and caregiver burden compared to programs A and B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: EMST | Active Comparator | The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device |
|
| Arm 2: Sham group | Sham Comparator | The Sham group undergoes the same 5-week EMST exercise as the experimental group using the same device but without a spring for minimal pressure load |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMST | Device | Pressure threshold device (Expiratory Muscle Strength Trainer) targeted at increase muscle force generation of expiratory and submental muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Expiratory Pressure (MEP) | Expiratory pressure generating capacity assessed via handheld manometer. | at baseline and again after 5-week EMST exercise |
| Penetration-Aspiration Scale Score | The Penetration-Aspiration Scale (PAS) was used to measure swallow safety. PAS is an 8 point ordinal scale for quantification of penetration and aspiration. PAS measures the depth to which material enters the airway and if the material is expelled following penetration or aspiration. Categorical groupings of PAS scores include "normal to mild" (1-2), "moderate" (3-5) and "severe" (6-8, indicating that material has passed into the lower airway). These PAS scores may be useful in denoting clinically significant changes (e.g. moderate to mild) resulting from treatment or disease progression. The following table reports the percentage of participants (out of the respective total group participants in EMST and Sham) with changed PAS score of 1 point or more (improving or worsening) and without PAS score changes from pre- to post treatment. The data represent an exploratory quantification without statistical analysis. | at baseline and again after 5-week EMST exercise |
| Swallow-related Quality of Life (SWAL-QOL) | The SWAL-QOL is a validated and standardized tool that measures burden; symptom status including pharyngeal, oral, and saliva; fear; and mental health subdomains. Responses are determined according to an ordinal scale where 1 equals a severe problem and 5 equals no problem. The SWAL-QOL provides an overall score as well as subscale scores. Subjects rate quality of life as follows (expressed as percentage of the possible perfect score): little to no impact (81% - 100%), mild impact (61% - 80%), moderate impact (41% - 60%), severe impact (21% - 40%), and profound impact (0% - 20%). | at baseline and after 5-week of EMST exercise |
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Inclusion Criteria:
Parkinson's Disease Participants
All Participants
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janis J. Daly, PhD MS | North Florida/South Georgia Veterans Health System, Gainesville, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: EMST | Experimental Group Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles. |
| FG001 | Arm 2: Sham Group | sham group sham device: Looks just like the EMST device but does not provide a load on the target muscle group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: EMST | Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles. |
| BG001 | Arm 2: Sham Group |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Maximum Expiratory Pressure (MEP) | Expiratory pressure generating capacity assessed via handheld manometer. | Out of the 42 recruited patients, 6 withdrew following the baseline MEP testing, citing travel or loss of interest as the reason. Therefore, 36 subjects were reported for the MEP test (n = 20 for EMST, n = 16 for sham). | Posted | Mean | Standard Deviation | cm H2O | at baseline and again after 5-week EMST exercise |
|
Seven-week period (baseline testing at week 1, then 5 weeks of the experimental training, and post-training testing at week 7)
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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 | Arm 1: EMST | Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Janis Daly | North Florida/South Georgia Veterans Health System | 352-376-1611 | 5223 | janis.daly@neurology.ufl.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009103 | Multiple Sclerosis |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Sham | Device | The same device just like the EMST but does not provide a load on the target muscle group |
|
Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
|
|
|
| Primary | Penetration-Aspiration Scale Score | The Penetration-Aspiration Scale (PAS) was used to measure swallow safety. PAS is an 8 point ordinal scale for quantification of penetration and aspiration. PAS measures the depth to which material enters the airway and if the material is expelled following penetration or aspiration. Categorical groupings of PAS scores include "normal to mild" (1-2), "moderate" (3-5) and "severe" (6-8, indicating that material has passed into the lower airway). These PAS scores may be useful in denoting clinically significant changes (e.g. moderate to mild) resulting from treatment or disease progression. The following table reports the percentage of participants (out of the respective total group participants in EMST and Sham) with changed PAS score of 1 point or more (improving or worsening) and without PAS score changes from pre- to post treatment. The data represent an exploratory quantification without statistical analysis. | Out of the 42 recruited patients, 8 failed to complete the PAS test either at baseline or post training testing. Therefore, 34 subjects were reported for the PAS test (n = 20 for EMST, n = 14 for sham). | Posted | Number | percentage of group participants | at baseline and again after 5-week EMST exercise |
|
|
|
| Primary | Swallow-related Quality of Life (SWAL-QOL) | The SWAL-QOL is a validated and standardized tool that measures burden; symptom status including pharyngeal, oral, and saliva; fear; and mental health subdomains. Responses are determined according to an ordinal scale where 1 equals a severe problem and 5 equals no problem. The SWAL-QOL provides an overall score as well as subscale scores. Subjects rate quality of life as follows (expressed as percentage of the possible perfect score): little to no impact (81% - 100%), mild impact (61% - 80%), moderate impact (41% - 60%), severe impact (21% - 40%), and profound impact (0% - 20%). | Out of the total 42 recruited study participants, ten either did not show up for the SWAL-QOL test or only partially answered the questionnaire. Thus, 32 remaining participants (n = 19 for EMST, and n = 13 for Sham) were reported. | Posted | Mean | Standard Deviation | percentage of possible perfect score | at baseline and after 5-week of EMST exercise |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Arm 2: Sham Group | Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group | 0 | 18 | 0 | 18 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| with worsened PAS after training |
|
| pre-training Burden |
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| post-training Burden |
|
| pre-training Pharyngeal |
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| post-training Pharyngeal |
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| pre-training Saliva |
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| post-training Saliva |
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| pre-training Oral |
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| post-training Oral |
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| pre-training Fear |
|
| post-training Fear |
|
| pre-training Mental Health |
|
| post-training Mental Health |
|
EMST arm vs. Sham arm group comparison of treatment response for total score and all subscale scores except for Burden and Pharyngeal domains
| > 0.05 |
| No |
| Superiority or Other |
| Plum Ordinal Regression Test | EMST arm vs. Sham arm group comparison of treatment response in Burden domain | 0.014 | No | Superiority or Other |
| Plum Ordinal Regression test | EMST arm vs. Sham arm group comparison of treatment response in Pharyngeal domain | 0.022 | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | >0.05 | Sham arm post vs. pre-treatment comparison for the total SWAL-QOL score and subscale scores except for the Burden and Mental Health domains. | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | Sham arm post vs. pre-treatment comparison in Burden domain | 0.038 | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | Sham arm post vs. pre-treatment comparison in Mental Health domain | 0.031 | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | EMST arm post vs. pre-treatment comparison in Burden domain | 0.027 | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | EMST arm post vs. pre-treatment comparison in Mental Health domain | 0.016 | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | EMST arm post vs. pre-treatment comparison in Pharyngeal domain | 0.007 | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | EMST arm post vs. pre-treatment comparison in Saliva domain | 0.036 | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | EMST arm post vs. pre-treatment comparison in Fear domain | 0.004 | No | Superiority or Other |
| Wilcoxon Signed Ranks Test | EMST arm post vs. pre-treatment comparison in Total SWAL-QOL score | 0.016 | No | Superiority or Other |