NCT00856518|CompletedPhase 2/3Results
Expiratory Muscle Training for Persons With Neurodegenerative Disease
EMST
Loading search results
Sponsor study identifier
interventional
42
1 country
1
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 3, 2009
Actual (reported)March 5, 2009
Actual (reported)August 2014
Actual (reported)August 2014
Actual (reported)November 29, 2016
Actual (reported)Maximum Expiratory Pressure (MEP)
Expiratory pressure generating capacity assessed via handheld manometer.
at baseline and again after 5-week EMST exercise
Penetration-Aspiration Scale Score
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.
at baseline and again after 5-week EMST exercise
Swallow-related Quality of Life (SWAL-QOL)
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%).
The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device
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
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
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608, United States
Janis J. Daly, PhD MS
North Florida/South Georgia Veterans Health System, Gainesville, FL
42 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2009
First Posted
March 5, 2009
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease
at baseline and after 5-week of EMST exercise
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
February 10, 2017
Results First Posted
November 29, 2016
Record last verified: 2016-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: