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NCT Number: NCT00856518

Expiratory Muscle Training for Persons With Neurodegenerative Disease

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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Key information

Conditions

Parkinson's Disease Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deglutition Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Immune System Diseases Movement Disorders Multiple Sclerosis Nervous System Diseases Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinson Disease Parkinsonian Disorders Pharyngeal Diseases Synucleinopathies

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMST

Device

Pressure threshold device (Expiratory Muscle Strength Trainer) targeted at increase muscle force generation of expiratory and submental muscles.

Other names: EMST 150

SHAM

Device

The same device just like the EMST but does not provide a load on the target muscle group

Primary outcomes

  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%).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Florida

Registry information

Acronym: EMST

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2009
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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