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Expiratory Muscle Training for Persons With Neurodegenerative Disease

Expiratory Muscle Training for Persons With Neurodegenerative Disease

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00856518
Acronym
EMST
Enrollment
42
Registered
2009-03-05
Start date
2009-03-31
Completion date
2014-08-31
Last updated
2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Parkinson's Disease

Keywords

Multiple Sclerosis, Parkinson's disease, Dysphagia

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.

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.

Interventions

DEVICEEMST

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

DEVICESham

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

Sponsors

University of Florida
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum Expiratory Pressure (MEP)at baseline and again after 5-week EMST exerciseExpiratory pressure generating capacity assessed via handheld manometer.
Penetration-Aspiration Scale Scoreat baseline and again after 5-week EMST exerciseThe 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.
Swallow-related Quality of Life (SWAL-QOL)at baseline and after 5-week of EMST exerciseThe 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%).

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1: EMST
Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
24
Arm 2: Sham Group
Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
18
Total42

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up42

Baseline characteristics

CharacteristicArm 1: EMSTArm 2: Sham GroupTotal
Age, Continuous53 years
STANDARD_DEVIATION 9
58 years
STANDARD_DEVIATION 8
55 years
STANDARD_DEVIATION 9
Gender
Female
18 Participants13 Participants31 Participants
Gender
Male
6 Participants5 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 240 / 18
serious
Total, serious adverse events
0 / 240 / 18

Outcome results

Primary

Maximum Expiratory Pressure (MEP)

Expiratory pressure generating capacity assessed via handheld manometer.

Time frame: at baseline and again after 5-week EMST exercise

Population: Out of the 42 recruited patients, 6 withdrew following the baseline MEP testing, citing travel or loss of interest as the reason. Therefore, 36 subjects were reported for the MEP test (n = 20 for EMST, n = 16 for sham).

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: EMSTMaximum Expiratory Pressure (MEP)baseline78.6 cm H2OStandard Deviation 30.72
Arm 1: EMSTMaximum Expiratory Pressure (MEP)post-training99.00 cm H2OStandard Deviation 32.97
Arm 2: ShamMaximum Expiratory Pressure (MEP)baseline75.56 cm H2OStandard Deviation 27.68
Arm 2: ShamMaximum Expiratory Pressure (MEP)post-training99.38 cm H2OStandard Deviation 37.59
p-value: 0.899Wilcoxon (Mann-Whitney)
p-value: 0.946Plum Ordinal Regression Test
p-value: 0.00042t-test, 2 sided
p-value: 0.0019t-test, 2 sided
Primary

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.

Time frame: at baseline and again after 5-week EMST exercise

Population: Out of the 42 recruited patients, 8 failed to complete the PAS test either at baseline or post training testing. Therefore, 34 subjects were reported for the PAS test (n = 20 for EMST, n = 14 for sham).

ArmMeasureGroupValue (NUMBER)
Arm 1: EMSTPenetration-Aspiration Scale Scorewith improved PAS after training40.0 percentage of group participants
Arm 1: EMSTPenetration-Aspiration Scale Scorewith unchanged PAS after training45.0 percentage of group participants
Arm 1: EMSTPenetration-Aspiration Scale Scorewith worsened PAS after training15.0 percentage of group participants
Arm 2: ShamPenetration-Aspiration Scale Scorewith improved PAS after training14.3 percentage of group participants
Arm 2: ShamPenetration-Aspiration Scale Scorewith unchanged PAS after training64.3 percentage of group participants
Arm 2: ShamPenetration-Aspiration Scale Scorewith worsened PAS after training21.4 percentage of group participants
Primary

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%).

Time frame: at baseline and after 5-week of EMST exercise

Population: Out of the total 42 recruited study participants, ten either did not show up for the SWAL-QOL test or only partially answered the questionnaire. Thus, 32 remaining participants (n = 19 for EMST, and n = 13 for Sham) were reported.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)post-traing total SWAL-QOL88.1 percentage of possible perfect scoreStandard Deviation 10.8
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)post-training Mental Health94.1 percentage of possible perfect scoreStandard Deviation 18.2
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)pre-training total SWAL-QOL83.3 percentage of possible perfect scoreStandard Deviation 11.5
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)pre-training Burden90.0 percentage of possible perfect scoreStandard Deviation 20
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)post-training Burden97.4 percentage of possible perfect scoreStandard Deviation 7.3
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)pre-training Pharyngeal73.5 percentage of possible perfect scoreStandard Deviation 16.9
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)post-training Pharyngeal82.4 percentage of possible perfect scoreStandard Deviation 16.6
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)pre-training Saliva84.2 percentage of possible perfect scoreStandard Deviation 16.2
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)post-training Saliva92.3 percentage of possible perfect scoreStandard Deviation 9.5
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)pre-training Oral95.3 percentage of possible perfect scoreStandard Deviation 7
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)post-training Oral96.9 percentage of possible perfect scoreStandard Deviation 4.5
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)pre-training Fear80.5 percentage of possible perfect scoreStandard Deviation 22.2
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)post-training Fear89.2 percentage of possible perfect scoreStandard Deviation 20.4
Arm 1: EMSTSwallow-related Quality of Life (SWAL-QOL)pre-training Mental Health87.2 percentage of possible perfect scoreStandard Deviation 21.5
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)post-training Mental Health90.2 percentage of possible perfect scoreStandard Deviation 13
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)post-training Oral91.2 percentage of possible perfect scoreStandard Deviation 9.8
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)pre-training Saliva83.1 percentage of possible perfect scoreStandard Deviation 13.5
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)pre-training Fear79.2 percentage of possible perfect scoreStandard Deviation 14.8
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)pre-training total SWAL-QOL81.4 percentage of possible perfect scoreStandard Deviation 10.9
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)post-traing total SWAL-QOL84.4 percentage of possible perfect scoreStandard Deviation 8.5
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)post-training Saliva83.6 percentage of possible perfect scoreStandard Deviation 15.8
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)pre-training Burden80.8 percentage of possible perfect scoreStandard Deviation 25
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)pre-training Mental Health83.4 percentage of possible perfect scoreStandard Deviation 16.5
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)post-training Burden86.2 percentage of possible perfect scoreStandard Deviation 18.9
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)pre-training Oral91.2 percentage of possible perfect scoreStandard Deviation 13.1
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)pre-training Pharyngeal75.4 percentage of possible perfect scoreStandard Deviation 13
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)post-training Fear84.6 percentage of possible perfect scoreStandard Deviation 11.3
Arm 2: ShamSwallow-related Quality of Life (SWAL-QOL)post-training Pharyngeal77.6 percentage of possible perfect scoreStandard Deviation 11.6
p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05Plum Ordinal Regression Test
p-value: 0.014Plum Ordinal Regression Test
p-value: 0.022Plum Ordinal Regression test
p-value: >0.05Wilcoxon Signed Ranks Test
p-value: 0.038Wilcoxon Signed Ranks Test
p-value: 0.031Wilcoxon Signed Ranks Test
p-value: 0.027Wilcoxon Signed Ranks Test
p-value: 0.016Wilcoxon Signed Ranks Test
p-value: 0.007Wilcoxon Signed Ranks Test
p-value: 0.036Wilcoxon Signed Ranks Test
p-value: 0.004Wilcoxon Signed Ranks Test
p-value: 0.016Wilcoxon Signed Ranks Test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026