Expiratory Muscle Training for Persons With Neurodegenerative Disease (EMST)

• ClinicalTrials.gov Identifier: NCT00856518
• Recruitment Status: Completed
• First Posted: March 5, 2009
• Results First Posted: November 29, 2016
• Last Update Posted: February 10, 2017
• Sponsor: VA Office of Research and Development
• Collaborator: University of Florida
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease; Multiple Sclerosis	Device: EMST; Device: Sham	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Expiratory Muscle Training for Persons With Neurodegenerative Disease
• Study Start Date: March 2009
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

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	Device: EMST; Pressure threshold device (Expiratory Muscle Strength Trainer) targeted at increase muscle force generation of expiratory and submental muscles.; Other Name: EMST 150
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	Device: Sham; The same device just like the EMST but does not provide a load on the target muscle group

Outcome Measures

Primary Outcome Measures :

1. Maximum Expiratory Pressure (MEP) [ Time Frame: at baseline and again after 5-week EMST exercise ]
   Expiratory pressure generating capacity assessed via handheld manometer.
2. Penetration-Aspiration Scale Score [ Time Frame: at baseline and again after 5-week EMST exercise ]
   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.
3. Swallow-related Quality of Life (SWAL-QOL) [ Time Frame: at baseline and after 5-week of EMST exercise ]
   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%).

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States, 32608

Sponsors and Collaborators

VA Office of Research and Development

University of Florida

Investigators

• Principal Investigator: Janis J. Daly, PhD MS; North Florida/South Georgia Veterans Health System, Gainesville, FL

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00856518
• Other Study ID Numbers: B6576-R
• First Posted: March 5, 2009
• Results First Posted: November 29, 2016
• Last Update Posted: February 10, 2017
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:

Multiple Sclerosis; Parkinson's disease; Dysphagia

Additional relevant MeSH terms:

Parkinson Disease; Multiple Sclerosis; Neurodegenerative Diseases; Sclerosis; Pathologic Processes; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases