Expiratory Muscle Training for Persons With Neurodegenerative Disease
Condition: Parkinson's Disease; Multiple Sclerosis
MeSH terms: Parkinson Disease; Multiple Sclerosis; Neurodegenerative Diseases; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): EMST; Sham
Intervention type(s): Device; Device
Intervention description(s): Pressure threshold device (Expiratory Muscle Strength Trainer) targeted at increase muscle force generation of expiratory and submental muscles.; The same device just like the EMST but does not provide a load on the target muscle group
Other intervention name(s): EMST 150
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Parkinson's disease; Dysphagia