View Clinical Trial (Medical Research Study)
Expiratory Muscle Training for Persons With Neurodegenerative Disease
| City: |
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Gainesville |
| State: |
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Florida |
| Zip Code: |
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32608 |
| Conditions: |
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Parkinson's Disease - Multiple Sclerosis |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT00856518 |
| Primary Contact: |
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Principal Investigator
Christine Sapienza, PhD MA BA
North Florida/South Georgia Veterans Health System
Erin Silverman, PhD
Phone: (352) 376-1611
Email: Erin.Silverman@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Gainesville, Florida 32608
United States
Erin Silverman, PhD
Phone: 352-376-1611
Email: Erin.Silverman@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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