Expiratory Muscle Training for Persons With Neurodegenerative Disease (EMST)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Expiratory Muscle Training for Persons With Neurodegenerative Disease|
- Maximum Expiratory Pressure (MEP) [ Time Frame: at baseline and again after 5-week EMST exercise ] [ Designated as safety issue: No ]Expiratory pressure generating capacity assessed via handheld manometer.
- Penetration-Aspiration Scale Score [ Time Frame: at baseline and again after 5-week EMST exercise ] [ Designated as safety issue: No ]The Penetration-Aspiration Scale (PAS) was used as a measure of 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). Categorization of PAS scores may be useful in denoting clinically significant change (e.g. moderate to mild) resulting from treatment or disease progression. Exploratory quantification of those participants with or without changes in PAS category expressed as the percentage of the respective group total participants in following either the EMST or Sham treatment was reported below (not involving statistical analysis).
- Swallow-related Quality of Life (SWAL-QOL) [ Time Frame: at baseline and after 5-week of EMST exercise ] [ Designated as safety issue: No ]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%).
|Study Start Date:||March 2009|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1: EMST
The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device
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
The same device just like the EMST but does not provide a load on the target muscle group
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856518
|United States, Florida|
|North Florida/South Georgia Veterans Health System, Gainesville, FL|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Janis J. Daly, PhD MS||North Florida/South Georgia Veterans Health System, Gainesville, FL|