EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy
Phase: NA
Conditions: Voice Disorder, Vocal Cord Atrophy, Presbyphonia
Sponsor: Emory University

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Phonation Resistance Training (PhoRTE) With And Without 
Expiratory Muscle Strength Training (EMST) For Patients With Presbyphonia 
 
NCT03696576 
 
Date: August 05, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Phonation Resistance Training (PhoRTE) With And Without 
Expiratory Muscle Strength Training (EMST) For Patients With Presbyphonia 
 
(PhoRTE/EMST Study) 
 
 
Amanda Gillespie, PhD, Co-I: Assistant Professor of Otolaryngology at Emory University School 
of Medicine, Director of Speech Pathology and Co-Director of Emory University Voice Center 
 
External Collaborators (University of Pittsburgh’s IRB will review their engagement in human 
subject research) 
Michael Belsky, BS, PI: Medical Student, University of Pittsburgh School of Medicine 
Jackie Gartner-Schmidt, PhD, PI: Co-Director of UPMC Voice Center and Professor, Department 
of Otolaryngology at the University of Pittsburgh School of Medicine 
Tina Harrison, BS, Study Coordinator: University of Pittsburgh Voice Center 
Scott Rothenberger, PhD, Statistician: Assistant Professor of Medicine and Clinical and 
Translational Science at the University of Pittsburgh School of Medicine 

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Abstract 
Respiratory and phonatory systems undergo various changes with age that can lead to changes 
in voice production. This condition is known as Presbyphonia. As respiratory muscles play a 
pivotal role in voice production. We aim to use an expiratory muscle strengthening training 
(EMST) device , in addition to standard therapy (Phonation resistant training exercise - PhoRTE) 
to improve voice outcomes in patients with Presbyphonia. The subjects with vocal atrophy will 
be enrolled and randomized into two groups: (a) Only Phonation resistant training exercise 
(PhoRTE) (b) PhoRTE with EMST. The outcomes measures will be pre and post acoustic and 
aerodynamic measures, Voice Handicap Index - 10 (VHI – 10), and Aging Voice Index (AVI). 
 
Background and Introduction 
The phonatory and respiratory systems undergo many age-related changes in their anatomy 
and physiology that can lead to undesirable effects on the voice. These changes have 
detrimental effects on the lives of elderly individuals. Few studies have evaluated the use of 
voice therapy treatment options for age-related voice disorders. The aim of this study is to 
compare a voice therapy program developed specifically for patients diagnosed with 
presbyphonia, Phonation Resistant Training Exercises (PhoRTE), with and without the addition 
of an expiratory muscle strength training (EMST) protocol that has been shown to strengthen 
the expiratory respiratory muscles. We hypothesize that the addition of EMST to PhoRTE is at 
least as effective as PhoRTE alone in treating vocal fold atrophy in elderly patients. 
 
Objective 
The primary objective of this study is to identify if there is additional benefit of providing EMST 
training to the individuals with Presbyphonia. We aim to compare the outcome measures 
between the two groups to conclude the results. 
 
Outcomes 
Outcomes will be collected at the start of the study, at the start of each therapy session, and 
during one-week post-therapy follow-up. 
 
This study is a two arm, prospective randomized investigation to examine the impact of PhoRTE 
and EMST on VHI-10, AVI, acoustic, aerodynamic, and auditory-perceptual outcomes collected 
pre-(baseline) and post-intervention (short-term follow-up). 
 
VHI-10 
The primary outcome is the Voice Handicap Index-10 (VHI-10) score.25 The VHI-10 is a patient- 
centered outcome that quantifies a patient’s perception of handicap caused by a voice disorder 
and will be measured at every session. VHI-10 will be anchored to baseline VHI-10 score (each 
item anchored) for the 1 week follow-up (will be administered without anchoring. Secondary 
outcomes include the following: 

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AVI 
The Aging Voice Index (AVI) is a new patient-centered outcome that quantifies quality of life 
impact a voice disorder has on older adults. It will be compared at baseline and during the final 
1-week follow up. 
 
Aerodynamic Measures 
Average airflow in speech, average number of breaths, average duration of a standard reading 
passage (The Rainbow Passage). Our prior work has demonstrated sensitivity to change 
following treatment for these acoustic and aerodynamic measures. 
 
Acoustic Measures 
Cepstral Spectral Index of Dysphonia (CSID), a multifactorial estimate of dysphonia severity that 
correlates with the visual analog scale for overall voice severity used in the Consensus Auditory- 
Perceptual Evaluation of Voice (CAPE-V), Cepstral Peak Prominence and its standard deviation, 
Cepstral Peak Prominence Fundamental Frequency (CPP F0) and its standard deviation, and 
average vocal intensity in dB SPL. 
 
Voice Quality by Blinded Raters 
Overall voice severity determined by CAPE-V score provided by blinded raters. 
 
Study design and Methods 
This is a prospective study. University of Pittsburgh will be recruiting patients as well under 
their own IRB. Emory participants will be voice patients from the Emory University Voice 
Center. A research coordinator will review clinic schedules to identify potential participants 
and will alert the clinical team members by affixing a notice to the potential participant’s chart. 
Once the clinical team has determined eligibility for the study based on evaluation/diagnosis, 
potential participants will be contacted and offered the opportunity to participate in the study. 
If the patient agree to participate they will be randomized to either of the study arms: (a) Only 
PhoRTE (b) PhoRTE with EMST. A randomization table will be created prior to recruit to 
determine the treatment assignment for each patient. 
 
Participants 
N=28 male and female participants diagnosed with vocal fold atrophy. 14 patients will be 
recruited for each arm of the study. 
 
Inclusion/Exclusion 
Age 65 years or older with chief complaint of a voice problem with VHI-10 >=1. Primary 
diagnosis of vocal fold atrophy only as determined by a multi-disciplinary team of fellowship- 
trained laryngologist and voice-specialized speech-language pathologist, and willingness to be 
randomized to treatment option. No concomitant laryngeal diagnoses or diseases known to 
affect voice function, including: amyloidosis, arytenoid dislocation, laryngeal cancer, 
cricoarytenoid fixation, vocal fold cyst(s), vocal nodules, vocal fold polyp(s), dysplasia, vocal fold 
fibrous mass(es), glottal web, vocal fold immobility, laryngeal stenosis, laryngocele, leukoplakia, 

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Parkinson’s disease, Reinke’s edema, respiratory recurrent pneumonia, sarcoidosis, spasmodic 
dysphonia; any chronic lower airway disease such as chronic obstructive pulmonary disease 
(COPD), asthma, chronic bronchitis, emphysema, cystic fibrosis; history of acute stroke, 
untreated hypertension, or untreated gastroesophageal reflux disease (GERD). 
 
Consent 
A trained study team member will be responsible for recruiting patients. On the day of their 
first visit, the informed consent will be obtained. The informed consent process will occur in a 
private room before starting any therapy. The participants will be randomized to either of the 
study arms, if they consent. 
 
 
Intervention/Experimental Protocol 
Outline Of Procedures 
The experimental protocol consists of pre-treatment and post-treatment acoustic and 
aerodynamic data collection and four 45-minute sessions of voice therapy. All subjects will 
complete PhoRTE therapy, and those in the EMST+PhoRTE arm in the study will also undergo 
EMST training. Before each PhoRTE therapy, subjects will report to the PI so that therapists are 
blinded as to which treatment group each subject is in. 
 
Baseline 
Pre-Tx Acoustic and 
Aerodynamic 
Measurements, 
VHI-10, AVI, MEP 
Therapy 1 
PhoRTE 
+/- EMST 
VHI-10 
MEP 
Therapy 2 
PhoRTE 
+/- EMST 
VHI-10 
MEP 
Therapy 3 
PhoRTE 
+/- EMST 
VHI-10 
MEP 
Therapy 4 
PhoRTE 
+/- EMST 
VHI-10 
MEP 
Post-Tx 
Acoustic and 
Aerodynamic 
Measurements, 
VHI-10, AVI, MEP 
 
PhoRTE Therapy (Standard of Care Treatment) 
Each therapy session will last for 45 minutes. 
1st PhoRTE treatment session 
- 
Check in with your patient about current status 
o Do you have any questions since we last met? Do you have any concerns about 
your ability to commit to PhoRTE? 
- 
Check in with the patient to verify implementation of voice care program 
o Dehydration, non-phonatory inflammation (reflux, illness) 
o Phonotrauma (throat clearing, cough) 
o Caffeine 
- 
Provide patients with PhoRTE therapy information sheets, phrase list, and practice 
sheets 
- 
Set up the patient for home practice 
o Verify that patient is able to download a decibel meter app successfully, and 
configure the app’s settings with a sound pressure level meter for home practice 

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o Orient the patient to the app; teach them how to open and utilize the app for 
home practice; demonstrate for the patient how to standardize mic-to-mouth 
distance 
o Verify that 10 functional phrases for practice are written. Review phrases for 
length and that they are representative of typical communication 
- 
Teaching proper breathing form 
o Establish efficient respiratory mechanisms to effectively execute PhoRTE 
exercises 
o Ex. “Place your hand on your upper abdomen just above your belly button. Now, 
I want you to sustain the sound “sh” for as long as is comfortable. Notice the 
inward movement of your hand as you exhale and sustain “sh.” Let’s practice 
this breathing a few more times until you feel comfortable with this task.” 
o Tip for clinician  monitor for hyper-functional muscle use in the abdomen and 
throat during these breathing tasks by visually or auditorily identifying any 
extraneous tension as well as by eliciting patient report 
- 
Teaching increased pulmonary drive 
o Clinician: “Now let’s practice the same task but make the “sh” stronger. This 
type of breathing is what you’ll need to effectively exercise your voice during 
PhoRTE. Notice that your hand moves in further and faster because you have to 
use more air to produce that “sh” with strength. Let’s practice this breathing a 
few more times until you feel comfortable with the task.” 
 
Before therapy sessions 
- 
Determine noise level in treatment room 
- 
Position sound level meter 12 inches from patient’s mouth 
- 
Sustain /a/ at modal pitch and comfortable loudness; have patient use speaking voice in 
two takes – Rainbow Passage and monologue of 30-60 sec 
- 
Calculate the patient’s vocal intensity range (i.e. maximum dB SPL minus minimum dB 
SPL 
- 
The starting PhoRTE vocal exercise target is 50-60% of dynamic range, and add dB SPL 
amount to average vocal intensity of monologue 
- 
Complete EMST calibration and MEP measurement (see description below) 
 
Exercise 1 – Phonation-Respiratory Isotonics (PhoRTE-ISO) 
- 
Clinician: “Place your hand on your upper abdomen. Now, I want you to sustain the 
sound “ah” with a strong, energized voice for as long as your are able. Your starting 
vocal intensity is 
dB. You will need to achieve your target vocal intensity and 
maintain it during the entire “ah” to get maximal benefit from this PhoRTE exercise. I 
want you to check that your mouth is at the appropriate distance from the app. Let’s 
practice this first PhoRTE exercise a few times until you feel comfortable with the task. 
Remember to record on your PhoRTE log the length of time you are able to hold each 
“ah.” 

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Exercise 2 – Eccentric-Concentric Cricothyroid Contraction (PhoRTE-EC) 
- 
Clinician: “Just like stretching exercises are good for your arms and legs to keep you 
young and flexible, first we are going to produce an ascending and descending pitch 
glide with a strong, energized voice without strain. Place your hand back on your upper 
abdomen. Again, your starting target vocal intensity is 
dB. You will need to achieve 
your target intensity and maintain it during the entire pitch glide. If you have difficulties 
achieving a strong, energized voice at the low wend of your range, don’t worry. That’s 
typical. After completing five ascending-descending glides, then reverse and produce 
five descending-ascending glides with a strong, energized voice without strain.” 
 
Exercise 3 – Phonation-Respiratory Power Endurance (PhoRTE-PE) 
- 
Exercise A  functional phrases in a higher, energized calling voice 
o Clinician: “Place your hand back on your upper abdomen. Again, your starting 
target vocal intensity is 
dB. You will need to achieve your target intensity 
and maintain it during the production of functional phrases. The first time we 
are going to say the phrases in a higher pitch with an energized voice as if we are 
calling to our neighbor by throwing your voice.” (Clinician demonstrates 
megaphone gesture with hands around mouth). Breathe as you feel necessary 
but avoid overtly large breaths before each subsequent 
- 
Exercise B  functional phrases in a lower, energized voice of authority 
o Clinician: “Place your hand back on your upper abdomen. Again, your starting 
target vocal intensity is 
dB. You will need to achieve your target intensity 
and maintain it during the production of functional phrases. This time we are 
going to say them in a lower pitch with an energized voice of authority. Breathe 
as you feel necessary but avoid overly large breaths before each subsequent 
sentence.” 
- 
Tips to the clinician 
o Start at resting expiratory level (the point in the breathing cycle at the end of 
quiet expiration). Beware they are not breath holding or using a 
strained/pressed production. The goal is for the patient to increase muscle 
activity of the abdominal musculature rather than over-utilizing/straining 
laryngeal musculature. Encourage the patient to, at most, take a small 
replenishing breath between each phrase. 
o Natural variability in vocal intensity around the target dB will exist due to 
differences in speech sound sonority and linguistic stress patterns. 
o Some patients have more difficulty with the voice of authority (vs. the calling 
voice). This difficulty may be due to a number of sources: (1) the positive nature 
of the phrase does not lend itself to a voice of authority, for example, “I love 
you; (2) structurally, the nature of presbyphonia results in patients using 
laryngeal compensation to achieve better vocal fold closure, which leads to a 
higher pitch; (3) some people’s personality or past experiences makes it 
uncomfortable for the patient to produce a voice of authority. The key for 
patients is to remember that this manner of production promotes the natural 

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pitch variability in conversation, and is not meant to conjure up negative feelings 
or emotions. 
o Have the patient observe an appropriate recovery period in which they sit silenty 
for a duration of 10-20 seconds between completion of exercises 3a and 3b. The 
purpose of the rest period is to, theoretically, clear lactic acid and other short- 
term metabolic effects of exercise. 
o Start at resting expiratory level (the point in the breathing cycle at the end of 
quiet expiration). Beware they are not breath holding or using a 
strained/pressed production. The goal is for the patient to increase muscle 
activity of the abdominal musculature rather than over-utilizing/straining 
laryngeal musculature. Encourage the patient to, at most, take a small 
replenishing breath between each phrase. 
 
Exercise 4 – Phonation-Respiratory Muscular Endurance-Short (PhoRTE-ME) 
- 
Clinician: “Place your hand back on your upper abdomen. Again, your starting vocal 
intensity is 
dB. You will need to achieve your target intensity and maintain it while 
you are speaking. We are going to speak in a strong, energized voice for a minimum of 
30 seconds but no more than 2 minutes. Breathe as you feel necessary but avoid overly 
large breaths before each subsequent sentence. 
 
EMST Training (Study procedure) 
The EMST device will be used to incrementally strengthen the respiratory muscles each week. 
The device will be calibrated each week using a manometer. Maximum expiratory pressure 
(MEP) will be measured before beginning each therapy session, and this will be used to 
calibrate the device for the weekly exercises. The device will be set to 75% of MEP for the 
week’s exercises. 
 
Recording Baseline and Post-Treatment Acoustic and Aerodynamic Measures 
Participants will read the following sentences/exercises for measurement of acoustic and 
aerodynamic values: 
Acoustic… 
1) “The blue spot is on the key again.” 
2) “How hard did he hit him?” 
3) “We were away a year ago.” 
4) “We eat eggs every Easter.” 
5) “My mama makes lemon muffins.” 
6) “Peter will keep at the park.” 
Aerodynamic… 
The Rainbow Passage: “When the sunlight strikes raindrops in the air, they act like a 
prism and form a rainbow. The rainbow is a division of white light into many beautiful colors. 
These take the shape of a long round arch, with its path high above, and its two ends 
apparently beyond the horizon. There is, according to legend, a boiling pot of gold at one end.” 

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Home Practice Forms 
 

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PhoRTE'"Voit:e ThDtapy Cli3'1ing Form 
PhoRTE PhrasK 
 
Write 10 phrases to speak us ng your strong PhoRTE voice.Sec the table below 
for gu dance onwriting 10 functional phrases for PhoRTE Exercises 3 and 4. 
 
Good Examples 
Poor Examples 
Hello,how are you? (5syllables) 
Hello.(too short) 
Ineed my medication.[7 sylables) 
Ineed my blood pressure medication that 
Itake every morning.(too long) 
Lefs go fora walk this morning. (8syllables) 
Lefs watch the solar ecipse.(not 
representative of daily demands) 
 
 
 
 
 
 
 
 
 
 
 
·1
.-- 
 
--------------------------- 
6.--------------------------- 
 
7.--------------------------- 
 
8.------------------------- 
 
9.------------------------- 
10. 
_ 

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Data collection and Management 
Research Electronic Data Capture (REDCap), will be used to manage all participant data from 
initial screening through study completion. Each subject will be given a subject number and 
patient’s identifying information will be stored in the database. Once the data collection is 
completed, the data will be downloaded from the REDcap application in a way that all personal 
health identifiers are removed. The deidentifed data will be stored in a secure Emory server and 
shared with University of Pittsburgh for the purpose of analysis. All the personal identifiers will 
be kept only in REDcap database until the completion of study. 

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Database Design 
Data will be collected and managed through REDcap database. It is a secure web application 
designed to support data capture for research studies, providing user friendly web-based case 
reports, data validation and a DE identified data export mechanism to statistical packages such 
as SAS, SPSS, STATA. 
 
Data Entry 
At the start of each therapy session, the study coordinator (PI or Co-I if study coordinator is not 
available) will have the participant sit in the Voice Research Lab and complete the following 
outcomes: 
- 
MEP measurement through the manometer 
- 
Complete VHI-10 in REDCap 
The study coordinator will enter the following data into REDCap: 
- 
Weekly practice logs for PhoRTE and/or EMST 
 
Data Reduction 
The PI will reduce the data according to the following protocol. 
 
Acoustic 
The sentence, “we were away a year ago” will be spliced and saved. File name: 
SubjectID_acoustic_timepoint. Ex: 06_acoustic_week1. 
Next, the ADSV software will be used to compute: CSID, CPP, CPP F0, CPP F0 sd, avg vocal 
intensity in dB SPL. 
Data entered in REDCap. 
 
Aerodynamic 
The passage will be reviewed and any errors or pauses deleted. The file will be saved. File 
name: SubjID_aero_timepoint. Ex: 06_aero_week3. 
The User Protocol One software in PAS will be used to calculate Average airflow in speech, 
average number of breaths, average duration of reading passage. 
Data entered in REDCap. 
 
Auditory Perceptual Analysis 
3 blinded raters (tbd) will listen to the sentence “we were away a year ago” and rate on 100mm 
VAS in REDCap. The initial and final evaluations will be rated, for a total of 2 samples per 
participant x 28 participants = 56 samples. 
Raters will be paid $20/hour for ratings. Ratings should take in total 2 hour-long sessions. 
 
 
Participant Payment 
Participants will be compensated $100 in total, $10 for the initial intake measurements, $10 for 
each therapy session attended, and $50 for the 1-week follow-up after therapy is completed. 

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Safety 
Adverse Events 
An interim analysis will be conducted at the midpoint of the study to ensure that PhoRTE+EMST 
is safe. During the study, each participant will be asked if they perceive their treatment to be 
harmful to them. If participants evince a VHI-10 increase of greater than 5 points34 in addition to 
reporting that voice therapy is harmful, then the study will be paused, re-evaluated, and 
possibly terminated. The study statistician (Dr. Rothenberger) will perform this interim analysis: 
clinical investigators will remain blinded to the results in order to avoid bias. Clinical 
investigators will only be informed of results if there is a substantial safety concern by the 
midpoint of the study. 
 
Fidelity Checks 
Each therapy session will be video-taped for future fidelity checks by the PI. These checks will 
ensure SLP accuracy in delivering CTT skill instructions, homework instructions, and maintaining 
conversation as the sole therapeutic stimulus. The review will occur after session 2 and 4 so  
that the PI can provide feedback to the SLP. 
 
Data Analysis Plan 
The purpose of the study is to measure any differences in the two study arms. Thus, t-test will 
be performed. Descriptive statistics will be utilized to identify the normality of the data. 
 
Summary 
The results from this study will allow the clinicians to improve patient outcomes. Hopefully, this 
study will be a precursor to future studies, aimed at treating Presbyphonia. 
 
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