- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00856518
Expiratory Muscle Training for Persons With Neurodegenerative Disease (EMST)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Multiple Sclerosis Participants
- Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist
- Over 85% of the patient populations that come from the study sites demonstrate relapsing-remitting MS with an average relapse frequency of once every 3 years
Parkinson's Disease Participants
- Hoehn & Yahr, stage II and III as indicated by certified movement disorders neurologist
All Participants
- Between 35 and 80 years of age
- Non-smoking or no smoking within the previous five years
- No history of head and neck cancer, asthma or COPD, untreated hypertension
- Sufficient facial muscle strength so as to achieve and maintain adequate lip closure around a circular mouthpiece
- Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE; 1975No neurological (other than MS or PD) condition which adversely affects respiratory muscle or gas exchange system
- Reduced MEP's compared to published normative data for age and sex
- Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s for 65 and older) during voluntary cough production for age and sex (Bolser, personal communication; Smith-Hammond & Goldstein, 2006)
- Participant report of symptoms related to swallow impairment
Exclusion Criteria:
- DBS
- COPD
- Asthma
- Smoking or smoking within preceding 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1: EMST
The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device
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Pressure threshold device (Expiratory Muscle Strength Trainer) targeted at increase muscle force generation of expiratory and submental muscles.
Other Names:
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Sham Comparator: Arm 2: Sham group
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
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The same device just like the EMST but does not provide a load on the target muscle group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Expiratory Pressure (MEP)
Time Frame: at baseline and again after 5-week EMST exercise
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Expiratory pressure generating capacity assessed via handheld manometer.
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at baseline and again after 5-week EMST exercise
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Penetration-Aspiration Scale Score
Time Frame: at baseline and again after 5-week EMST exercise
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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.
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at baseline and again after 5-week EMST exercise
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Swallow-related Quality of Life (SWAL-QOL)
Time Frame: at baseline and after 5-week of EMST exercise
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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%).
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at baseline and after 5-week of EMST exercise
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Janis J. Daly, PhD MS, North Florida/South Georgia Veterans Health System, Gainesville, FL
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Multiple Sclerosis
- Sclerosis
- Parkinson Disease
- Neurodegenerative Diseases
Other Study ID Numbers
- B6576-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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