Trial Outcomes & Findings for Expiratory Muscle Training for Persons With Neurodegenerative Disease (NCT NCT00856518)

NCT ID: NCT00856518

Last Updated: 2017-02-10

Results Overview

Expiratory pressure generating capacity assessed via handheld manometer.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

42 participants

Primary outcome timeframe

at baseline and again after 5-week EMST exercise

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: EMST Experimental Group Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.	Arm 2: Sham Group sham group sham device: Looks just like the EMST device but does not provide a load on the target muscle group
Overall Study STARTED	24	18
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: EMST Experimental Group Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.	Arm 2: Sham Group sham group sham device: Looks just like the EMST device but does not provide a load on the target muscle group
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

Expiratory Muscle Training for Persons With Neurodegenerative Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: EMST n=24 Participants Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.	Arm 2: Sham Group n=18 Participants Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group	Total n=42 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 9 • n=5 Participants	58 years STANDARD_DEVIATION 8 • n=7 Participants	55 years STANDARD_DEVIATION 9 • n=5 Participants
Gender Female	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Expiratory pressure generating capacity assessed via handheld manometer.

Outcome measures

Outcome measures
Measure	Arm 1: EMST n=20 Participants EMST Group Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.	Arm 2: Sham n=16 Participants Sham group sham device: Looks just like the EMST device but does not provide a load on the target muscle group
Maximum Expiratory Pressure (MEP) baseline	78.6 cm H2O Standard Deviation 30.72	75.56 cm H2O Standard Deviation 27.68
Maximum Expiratory Pressure (MEP) post-training	99.00 cm H2O Standard Deviation 32.97	99.38 cm H2O Standard Deviation 37.59

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Arm 1: EMST n=20 Participants EMST Group Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.	Arm 2: Sham n=14 Participants Sham group sham device: Looks just like the EMST device but does not provide a load on the target muscle group
Penetration-Aspiration Scale Score with worsened PAS after training	15.0 percentage of group participants	21.4 percentage of group participants
Penetration-Aspiration Scale Score with improved PAS after training	40.0 percentage of group participants	14.3 percentage of group participants
Penetration-Aspiration Scale Score with unchanged PAS after training	45.0 percentage of group participants	64.3 percentage of group participants

PRIMARY outcome

Timeframe: 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.

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%).

Outcome measures

Outcome measures
Measure	Arm 1: EMST n=19 Participants EMST Group Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.	Arm 2: Sham n=13 Participants Sham group sham device: Looks just like the EMST device but does not provide a load on the target muscle group
Swallow-related Quality of Life (SWAL-QOL) pre-training Saliva	84.2 percentage of possible perfect score Standard Deviation 16.2	83.1 percentage of possible perfect score Standard Deviation 13.5
Swallow-related Quality of Life (SWAL-QOL) pre-training total SWAL-QOL	83.3 percentage of possible perfect score Standard Deviation 11.5	81.4 percentage of possible perfect score Standard Deviation 10.9
Swallow-related Quality of Life (SWAL-QOL) post-traing total SWAL-QOL	88.1 percentage of possible perfect score Standard Deviation 10.8	84.4 percentage of possible perfect score Standard Deviation 8.5
Swallow-related Quality of Life (SWAL-QOL) pre-training Burden	90.0 percentage of possible perfect score Standard Deviation 20.0	80.8 percentage of possible perfect score Standard Deviation 25.0
Swallow-related Quality of Life (SWAL-QOL) post-training Burden	97.4 percentage of possible perfect score Standard Deviation 7.3	86.2 percentage of possible perfect score Standard Deviation 18.9
Swallow-related Quality of Life (SWAL-QOL) pre-training Pharyngeal	73.5 percentage of possible perfect score Standard Deviation 16.9	75.4 percentage of possible perfect score Standard Deviation 13.0
Swallow-related Quality of Life (SWAL-QOL) post-training Pharyngeal	82.4 percentage of possible perfect score Standard Deviation 16.6	77.6 percentage of possible perfect score Standard Deviation 11.6
Swallow-related Quality of Life (SWAL-QOL) post-training Saliva	92.3 percentage of possible perfect score Standard Deviation 9.5	83.6 percentage of possible perfect score Standard Deviation 15.8
Swallow-related Quality of Life (SWAL-QOL) pre-training Oral	95.3 percentage of possible perfect score Standard Deviation 7.0	91.2 percentage of possible perfect score Standard Deviation 13.1
Swallow-related Quality of Life (SWAL-QOL) post-training Oral	96.9 percentage of possible perfect score Standard Deviation 4.5	91.2 percentage of possible perfect score Standard Deviation 9.8
Swallow-related Quality of Life (SWAL-QOL) pre-training Fear	80.5 percentage of possible perfect score Standard Deviation 22.2	79.2 percentage of possible perfect score Standard Deviation 14.8
Swallow-related Quality of Life (SWAL-QOL) post-training Fear	89.2 percentage of possible perfect score Standard Deviation 20.4	84.6 percentage of possible perfect score Standard Deviation 11.3
Swallow-related Quality of Life (SWAL-QOL) pre-training Mental Health	87.2 percentage of possible perfect score Standard Deviation 21.5	83.4 percentage of possible perfect score Standard Deviation 16.5
Swallow-related Quality of Life (SWAL-QOL) post-training Mental Health	94.1 percentage of possible perfect score Standard Deviation 18.2	90.2 percentage of possible perfect score Standard Deviation 13.0

Adverse Events

Arm 1: EMST

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Sham Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Janis Daly

North Florida/South Georgia Veterans Health System

Phone: 352-376-1611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place